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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02227108
Registration number
NCT02227108
Ethics application status
Date submitted
21/08/2014
Date registered
27/08/2014
Date last updated
6/04/2017
Titles & IDs
Public title
Study in Pediatrics With Relapsed or Refractory Pediatric Acute Lymphoblastic Leukemia (pALL) or Lymphoblastic Lymphoma
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Scientific title
A Phase 2, Multicenter, Single-arm Study of Moxetumomab Pasudotox in Pediatric Subjects With Relapsed or Refractory Pediatric Acute Lymphoblastic Leukemia (pALL) or Lymphoblastic Lymphoma of B-cell Origin
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Secondary ID [1]
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CD-ON-CAT-8015-1036
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
B-Cell Pediatric ALL
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Moxetumomab Pasudotox
Experimental: Moxetumomab Pasudotox 40 mcg/kg - Participants received 6 doses of moxetumomab pasudotox 40 microgram per kilogram (mcg/kg) intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
Treatment: Drugs: Moxetumomab Pasudotox
Participants received 6 doses of moxetumomab pasudotox 40 microgram per kilogram (mcg/kg) intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Composite Complete Response (CRc)
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Assessment method [1]
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The CRc is defined as achieving complete response (CR), or CR with incomplete count recovery [CRi]) in participants with relapsed or refractory B-cell ALL or B-cell lymphoblastic lymphoma. Complete response (CR) as per International Working Group (IWG) is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Morphologic CR with incomplete blood count recovery (CRi) is defined as the above CR criteria without specified blood counts. The efficacy assessments were evaluated as per investigator assessment.
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Timepoint [1]
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Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year
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Secondary outcome [1]
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Percentage of Participants With Minimal Residual Disease (MRD)-Negative CRc Rate
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Assessment method [1]
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The MRD-negative CRc rate was defined as the percentage of participants who achieved CRc and became MRD-negative as determined by flow cytometry performed by a central analysis laboratory. The CRc is defined as complete response (CR), or complete response with incomplete count recovery (CRi). Complete response (CR) as per International Working Group (IWG) is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Morphologic CR with incomplete blood count recovery (CRi) is defined as the above CR criteria without specified blood counts.
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Timepoint [1]
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Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year
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Secondary outcome [2]
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Overall Response Rate (ORR)
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Assessment method [2]
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The ORR, defined as the percentage of participants with CRc or partial response (PR), was estimated; the Clopper Pearson (Exact) 95% CI was calculated. The CRc is defined as complete response (CR), or complete response with incomplete count recovery (CRi). Complete response (CR) as per International Working Group (IWG) is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Morphologic CR with incomplete blood count recovery (CRi) is defined as the above CR criteria without specified blood counts.
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Timepoint [2]
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Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year
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Secondary outcome [3]
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Time to Overall Response
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Assessment method [3]
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Time to overall response was evaluated using the Kaplan-Meier method.
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Timepoint [3]
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Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year
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Secondary outcome [4]
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Best Overall Response (BOR)
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Assessment method [4]
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The best overall response was calculated, based upon the disease assessments recorded during the study visits, and summarized with the number and percentage of participants for the following categories: CRc, PR, HA, SD, PD, and not evaluable. Overall best response is the best response observed for a participant during the study based on International Working Group (IWG) Response Criteria for malignant lymphoma. Complete response (CR) as per IWG is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. PR is a minimum of 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses and no increase in the size of other nodes and in size of liver or spleen. Stable disease (SD) is when a participant fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD.
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Timepoint [4]
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Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year
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Secondary outcome [5]
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Bone Marrow Blast Percentage Change
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Assessment method [5]
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Change in bone marrow blast percentage from baseline was evaluated. If the percentage (%) blasts (at least 200 cells counted) is less than (<) 5%, it is considered as M1, 5 to 25% considered as M2, greater than (>) 25% considered as M3. Stages with the higher blasts relate to worse outcomes.
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Timepoint [5]
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Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year
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Secondary outcome [6]
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Percentage of Participants Who Became Eligible to Receive an Stem Cell Transplant (SCT) After Treatment With Moxetumomab Pasudotox
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Assessment method [6]
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The percentage of participants who became eligible for SCT after treatment with moxetumomab pasudotox were provided. The Clopper Pearson (Exact) 95% CI was calculated.
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Timepoint [6]
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Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year
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Secondary outcome [7]
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Time to Transplant to Receive an Stem Cell Transplant (SCT) After Treatment With Moxetumomab Pasudotox
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Assessment method [7]
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The time to SCT was defined as the duration from the start of treatment with moxetumomab pasudotox until the date when the subject became eligible for SCT. The time to SCT was to be summarized using the Kaplan-Meier method, and was only to be evaluated for the subgroup of subjects who became eligible for SCT after treatment with moxetumomab pasudotox.
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Timepoint [7]
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Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year
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Secondary outcome [8]
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Percentage of Participants Who Were Neutropenic at Study Entry and Who Experienced Hematologic Activity (HA)
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Assessment method [8]
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The percentage of participants who were neutropenic at study entry and experienced HA after treatment with moxetumomab pasudotox was evaluated. The Clopper Pearson (Exact) 95% CI was calculated.
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Timepoint [8]
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Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year
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Secondary outcome [9]
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Duration of Complete Response (DOCR)
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Assessment method [9]
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DOCR was defined as the duration from the first documentation of CRc to the first documented disease progression.The CRc is defined as achieving complete response (CR), or CR with incomplete count recovery [CRi]) in participants with relapsed or refractory B-cell ALL or B-cell lymphoblastic lymphoma. Kaplan-Meier method was used for evaluation.
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Timepoint [9]
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Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year
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Secondary outcome [10]
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Duration of Overall Response (DOR)
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Assessment method [10]
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DOR was to be defined as the duration from the first documentation of overall response to the first documented disease progression. Kaplan-Meier method was used for evaluation.
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Timepoint [10]
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Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year
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Secondary outcome [11]
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Progression-Free Survival (PFS)
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Assessment method [11]
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PFS was measured from the start of treatment with moxetumomab pasudotox until the first documentation of disease progression or death due to any cause, whichever occurred first. Kaplan-Meier method was used for evaluation.
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Timepoint [11]
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Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year
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Secondary outcome [12]
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Overall Survival (OS)
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Assessment method [12]
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OS was determined as the time from the start of treatment with moxetumomab pasudotox until death due to any cause. For participants who were alive at the end of the study or lost to follow-up, OS was censored on the last date when the participant was known be alive. Kaplan-Meier method was used for evaluation.
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Timepoint [12]
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Baseline to end of study or last contact date, up to 1 year
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Secondary outcome [13]
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
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Assessment method [13]
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Treatment-emergent adverse events (TEAEs), were defined as events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug.
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Timepoint [13]
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Baseline up to 30 days after the last dose of study drug, up to 1 year
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Secondary outcome [14]
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Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAE)
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Assessment method [14]
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Laboratory tests were grouped according to hematology, serum chemistry, and urinalysis. Laboratory abnormalities with toxicity grades according to NCI CTCAE Version 4.03 were derived according to laboratory values and reported as treatment-emergent adverse events.
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Timepoint [14]
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Baseline up to 30 days after the last dose of study drug, up to 1 year
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Secondary outcome [15]
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Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
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Assessment method [15]
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Participants were evaluated for ECG abnormalities.
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Timepoint [15]
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Baseline up to 30 days after the last dose of study drug, up to 1 year
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Secondary outcome [16]
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Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)
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Assessment method [16]
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Participants who experienced vital signs abnormalities recorded as TEAEs were reported.
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Timepoint [16]
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Baseline up to 30 days after the last dose of study drug, up to 1 year
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Secondary outcome [17]
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Number of Participants With Positive Anti-drug Antibody (ADA) and Neutralizing Antibodies (NAb)
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Assessment method [17]
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Immunogenicity assessment included determination of antidrug (moxetumomab pasudotox) antibodies and neutralizing antidrug antibodies in serum samples. Titers and specificity were determined for NAb-positive participants. Specificity were observed in participants who had ADAs directed to the PE38 domain of moxetumomab pasudotox and increase in titers were observed in participants who tested ADA-positive at baseline. Moxetumomab pasudotox ADA-titer is a validated immunoassay, which determines titers or levels of ADAs present in ADA-positive samples.
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Timepoint [17]
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Prior to the Start of Each Cycle for Cycles 1, 2, 3, and Subsequent Odd-Numbered Cycles, End of Treatment, and 30 Day Follow-up Visit, up to 1 year
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Secondary outcome [18]
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Area Under the Plasma Concentration Time Curve From Time 0 to Infinity (AUC0-inf) After the First Dose of Cycle 1
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Assessment method [18]
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AUC (0-infinity) = Area under the serum concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (tinfinity). It was calculated by extrapolating the concentrationtime curve from time zero to infinity using the linear/log trapezoidal rule.
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Timepoint [18]
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Pre-infusion, end of infusion (EOI); 1, 3, and 6 hours post-infusion of Day 1 of Cycle 1
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Secondary outcome [19]
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Area Under the Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration [AUC0-last] After the First Dose of Cycle 1
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Assessment method [19]
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AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC0-t is defined as AUC from time zero to the last data point above the lower limit of quantification.
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Timepoint [19]
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Pre-infusion, end of infusion (EOI); 1, 3, and 6 hours post-infusion at Day 1 of Cycle 1
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Secondary outcome [20]
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Maximum Observed Drug Concentration in Plasma (Cmax) After the First Dose of Cycle 1
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Assessment method [20]
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Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
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Timepoint [20]
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Pre-infusion, end of infusion (EOI); 1, 3, and 6 hours post-infusion at Day 1 of Cycle 1
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Secondary outcome [21]
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Time to Reach Maximum Drug Concentration in Plasma (Tmax) After the First Dose of Cycle 1
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Assessment method [21]
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Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.
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Timepoint [21]
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Pre-infusion, end of infusion (EOI); 1, 3, and 6 hours post-infusion at Day 1 of Cycle 1
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Secondary outcome [22]
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Terminal Phase Elimination Half Life (t1/2) After the First Dose of Cycle 1
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Assessment method [22]
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Terminal phase elimination half-life is the time measured for the serum/plasma concentration to decrease by one half, calculated as natural logarithmic (log)-transformed (ln) value of 2 divided by elimination rate constant (lambda); that is [ln(2)/lambda]. Elimination rate constant (lambda) was estimated via linear regression of the time versus log concentration.
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Timepoint [22]
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Pre-infusion, end of infusion (EOI); 1, 3, and 6 hours post-infusion at Day 1 of Cycle 1
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Secondary outcome [23]
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Systemic Clearance (CL) After the First Dose of Cycle 1
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Assessment method [23]
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CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]).
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Timepoint [23]
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Pre-infusion, end of infusion (EOI); 1, 3, and 6 hours post-infusion at Day 1 of Cycle 1
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Eligibility
Key inclusion criteria
Inclusion Criteria -
1. Between the ages of greater or equal to (=) 6 months and less than (<) 18 years of age
2. Must have histologically proven B-cell acute lymphoblastic leukemia (ALL) or B-cell
lymphoblastic lymphoma with marrow involvement
3. All participants (both ALL and participants with lymphoblastic lymphoma) must have M2
or M3 bone marrow classification
4. Disease status: a) Participants must have relapsed or refractory disease b) In the
event of relapse after prior allogeneic hematopoietic stem cell transplant (HSCT),
participants must be at least 3 months post-transplant and have no evidence of active
graft-vs-host disease, and must have been off immunosuppression for at least 4 weeks,
c) Must have resolution of the acute toxic effects to less than or equal to (=) Grade
2 from prior chemotherapy before entry, in the opinion of the investigator
5. Participants with the following central nervous system (CNS) 1 or 2 status are
eligible only in the absence of neurologic symptoms
6. Female participants of childbearing potential and post-pubertal male participants must
use an approved method of contraception for the study.
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Minimum age
6
Months
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
1. Concurrent enrollment in another clinical study for cancer treatment, unless the
subject is in the follow-up period from a previous study.
2. Isolated testicular or CNS ALL
3. Participants with mixed-lineage leukemia (MLL) gene rearrangement
4. Inadequate Hepatic function
5. Inadequate Renal function
6. Radiologically-detected CNS lymphoma
7. Participants with clear laboratory or clinical evidence of disseminated intravascular
coagulation (DIC)
8. Hyperleukocytosis or rapidly progressive disease that would compromise ability to
complete study therapy
9. QT interval corrected using Fridericia's formula (QTcF) greater than or equal to a
Grade 2, confirmed by 2 additional seperate electrocardiographs (ECG's) within 28 days
prior to starting study drug. The initial screening ECG need not be repeated for
confirmation if the QTcF interval is <481 milliseconds.
10. Pregnant or breast-feeding females
11. Prior treatment with CAT-3888 (BL22), moxetumomab pasudotox, or any
pseudomonas-exotoxin-containing compound
12. Prior treatment with any anticancer biologic therapy within 2 weeks prior to starting
study drug, including but not limited to therapeutic monoclonal antibodies or
antibody-drug conjugates
13. Systemic chemotherapy = 2 weeks (6 weeks for nitrosoureas) and radiation therapy = 3
weeks prior to starting study drug
14. Clinically significant ophthalmologic findings (evidence of retinal damage or injury)
during the screening
15. Presence of a second invasive malignancy
16. Uncontrolled pulmonary infection, presence of pulmonary edema
17. Serum albumin < 2 gram per deciliter (g/dL). Albumin infusions for correction of
hypoalbuminemia are allowed, but cannot have administered within 7 days prior to start
of study drug
18. Radioimmunotherapy within 2 years prior to study start of study drug
19. Participants with prior history of thrombotic microangiopathy or hemolytic uremic
syndrome (HUS)
20. T-cell ALL or T-cell lymphoblastic lymphoma
21. Participants currently receiving high-dose estrogen therapy defined as >0.625
milligram per day (mg/day) of an estrogen compound or within 2 weeks prior to starting
study drug.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2015
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Sample size
Target
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Accrual to date
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Final
37
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Parkville
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Recruitment hospital [2]
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Research Site - Westmead
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Recruitment postcode(s) [1]
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- Parkville
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Recruitment postcode(s) [2]
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- Westmead
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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0
United States of America
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State/province [3]
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Illinois
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Country [4]
0
0
United States of America
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State/province [4]
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Maryland
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Country [5]
0
0
United States of America
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State/province [5]
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0
Missouri
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Country [6]
0
0
United States of America
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State/province [6]
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0
New York
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Country [7]
0
0
United States of America
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State/province [7]
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0
North Carolina
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Country [8]
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0
United States of America
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State/province [8]
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0
Ohio
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Country [9]
0
0
United States of America
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State/province [9]
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0
Pennsylvania
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Washington
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Country [11]
0
0
Canada
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State/province [11]
0
0
Alberta
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Country [12]
0
0
France
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State/province [12]
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0
Lyon
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Country [13]
0
0
France
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State/province [13]
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Paris
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Country [14]
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France
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State/province [14]
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0
Vandoeuvre les Nancy Cedex
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Country [15]
0
0
Italy
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State/province [15]
0
0
Rome
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Country [16]
0
0
Netherlands
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State/province [16]
0
0
Rotterdam
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Country [17]
0
0
Spain
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State/province [17]
0
0
Barcelona
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Country [18]
0
0
Spain
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State/province [18]
0
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Madrid
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Country [19]
0
0
United Kingdom
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State/province [19]
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Bristol
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
MedImmune LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective of this study is to evaluate the efficacy of moxetumomab pasudotox in
pediatric participants with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL)
or B-cell lymphoblastic lymphoma.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02227108
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Trial related presentations / publications
Mussai F, Campana D, Bhojwani D, Stetler-Stevenson M, Steinberg SM, Wayne AS, Pastan I. Cytotoxicity of the anti-CD22 immunotoxin HA22 (CAT-8015) against paediatric acute lymphoblastic leukaemia. Br J Haematol. 2010 Aug;150(3):352-8. doi: 10.1111/j.1365-2141.2010.08251.x. Epub 2010 Jun 7.
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Public notes
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Contacts
Principal investigator
Name
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Medimmune Inc. Medimmune Inc.
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Address
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MedImmune LLC
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Country
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Phone
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Fax
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Email
0
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02227108
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