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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/NCT02101853
Registration number
NCT02101853
Ethics application status
Date submitted
28/03/2014
Date registered
2/04/2014
Date last updated
22/03/2024
Titles & IDs
Public title
Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia
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Scientific title
Risk-Stratified Randomized Phase III Testing of Blinatumomab (NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)
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Secondary ID [1]
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NCI-2014-00631
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Secondary ID [2]
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NCI-2014-00631
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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:
Recurrent B Acute Lymphoblastic Leukemia
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Condition category
Condition code
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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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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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Allogeneic Hematopoietic Stem Cell Transplantation
Treatment: Drugs - Asparaginase
Other interventions - Blinatumomab
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Cytarabine
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Etoposide
Treatment: Drugs - Leucovorin Calcium
Treatment: Drugs - Mercaptopurine
Treatment: Drugs - Methotrexate
Treatment: Drugs - Mitoxantrone
Treatment: Drugs - Mitoxantrone Hydrochloride
Treatment: Drugs - Pegaspargase
Other interventions - Pharmacological Study
Treatment: Other - Radiation Therapy
Treatment: Drugs - Therapeutic Hydrocortisone
Treatment: Drugs - Thioguanine
Treatment: Drugs - Vincristine
Treatment: Drugs - Vincristine Sulfate
Active Comparator: Arm A (HR and IR control) - Patients receive Block 2 over 4 weeks, Block 3 over 4 weeks, and then undergo allogeneic HSCT. Closed effective September 18, 2019.
Experimental: Arm B (HR and IR blinatumomab) - Patients receive Blinatumomab Block 1 over 5 weeks, Blinatumomab Block 2 over 5 weeks, and then undergo allogeneic HSCT.
Active Comparator: Arm C (LR control) - Patients receive Block 2 over 4 weeks, Block 3 over 4 weeks, Continuation 1 over 8 weeks, Continuation 2 over 8 weeks, and then Maintenance.
Experimental: Arm D (LR blinatumomab) - Patients receive Block 2 over 4 weeks, Blinatumomab Cycle 1 over 5 weeks, Continuation 1 over 8 weeks, Blinatumomab Cycle 2 over 5 weeks, Continuation 2 over 8 weeks, Blinatumomab Cycle 3 over 5 weeks, and then Maintenance.
Treatment: Surgery: Allogeneic Hematopoietic Stem Cell Transplantation
Undergo allogeneic HSCT
Treatment: Drugs: Asparaginase
Given IM or IV
Other interventions: Blinatumomab
Given IV
Treatment: Drugs: Cyclophosphamide
Given IV
Treatment: Drugs: Cytarabine
Given IT and IV or SC
Treatment: Drugs: Dexamethasone
Given PO or IV
Treatment: Drugs: Etoposide
Given IV
Treatment: Drugs: Leucovorin Calcium
Given IV or PO
Treatment: Drugs: Mercaptopurine
Given PO
Treatment: Drugs: Methotrexate
Given IT, IV, and PO
Treatment: Drugs: Mitoxantrone
Given IV
Treatment: Drugs: Mitoxantrone Hydrochloride
Given IV
Treatment: Drugs: Pegaspargase
Given IV
Other interventions: Pharmacological Study
Correlative studies
Treatment: Other: Radiation Therapy
Undergo cranial radiation therapy
Treatment: Drugs: Therapeutic Hydrocortisone
Given IT
Treatment: Drugs: Thioguanine
Given PO
Treatment: Drugs: Vincristine
Given IV
Treatment: Drugs: Vincristine Sulfate
Given IV
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Intervention code [1]
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Treatment: Surgery
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Intervention code [2]
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Treatment: Drugs
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Intervention code [3]
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Other interventions
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Intervention code [4]
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Treatment: Other
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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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Disease Free Survival (DFS) of High-risk (HR) and Intermediate-risk (IR) Relapse Patients
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Assessment method [1]
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DFS rates of HR and IR relapse B-ALL patients who are randomized following Induction Block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab (HR/IR Randomization). DFS is calculated as the time from randomization to date of first event (treatment failure, relapse, second malignancy, remission death) or date of last contact. Two-year DFS estimates will be calculated from date of randomization for both Arm A and Arm B. Two-sided 95% confidence intervals will be calculated.
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Timepoint [1]
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Up to 2 years from date of randomization
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Primary outcome [2]
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Disease Free Survival (DFS) of Low Risk (LR) Relapse Patients
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Assessment method [2]
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DFS rates of LR relapse B-ALL patients who are randomized following Block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR Randomization). DFS is calculated as the time from randomization to date of first event (relapse, second malignancy, remission death) or date of last contact. Three-year DFS estimates will be calculated from date of randomization for both Arm C and Arm D. Two-sided 95% confidence intervals will be calculated.
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Timepoint [2]
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Up to 3 years from date of randomization
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Secondary outcome [1]
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Overall Survival (OS) of HR and IR Relapse Patients
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Assessment method [1]
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OS rates of HR and IR relapse B-ALL patients who are randomized following Induction Block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab (HR/IR Randomization). OS is calculated as the time from randomization to date of death or date of last contact. Two-year OS estimates will be calculated from date of randomization for both Arm A and Arm B. Two-sided 95% confidence intervals will be calculated.
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Timepoint [1]
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Up to 2 years from date of randomization
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Secondary outcome [2]
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Overall Survival (OS) of LR Relapse Patients
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Assessment method [2]
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OS rates of LR relapse B-ALL patients who are randomized following Block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR Randomization). OS is calculated as the time from randomization to date of death or date of last contact. Three-year OS estimates will be calculated from date of randomization for both Arm C and Arm D. Two-sided 95% confidence intervals will be calculated.
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Timepoint [2]
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Up to 3 years from date of randomization
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Eligibility
Key inclusion criteria
- Patients >= 1 year and < 31 years of age at the time of relapse will be eligible
- First relapse of B-ALL, allowable sites of disease include isolated bone marrow,
combined bone marrow and CNS and/or testicular, and isolated CNS and/or testicular;
extramedullary sites are limited to the CNS and testicles
- No waiting period for patients who relapse while receiving standard maintenance
therapy
- Patients who relapse on frontline therapy in phases other than maintenance must have
fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy,
or radiotherapy prior to entering this study
- Cytotoxic therapy: at least 14 days since the completion of cytotoxic therapy with the
exception of hydroxyurea, which is permitted up to 24 hours prior to the start of
protocol therapy, or maintenance chemotherapy, or intrathecal chemotherapy
(methotrexate strongly preferred) administered at the time of the required diagnostic
lumbar puncture to establish baseline CNS status
- Biologic (anti-neoplastic) agent: at least 7 days since the completion of therapy with
a biologic agent; for agents that have known adverse events occurring beyond 7 days
after administration, this period must be extended beyond the time during which
adverse events are known to occur
- Stem cell transplant or rescue: patient has not had a prior stem cell transplant or
rescue
- Patient has not had prior treatment with blinatumomab
- With the exception of intrathecal chemotherapy (methotrexate strongly preferred;
cytarabine is permissible) administered at the time of the required diagnostic lumbar
puncture to establish baseline CNS status, patient has not received prior
relapse-directed therapy (i.e., this protocol is intended as the INITIAL treatment of
first relapse)
- Patients must have a performance status corresponding to Eastern Cooperative Oncology
Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients > 16 years of age and
Lansky for patients =< 16 years of age
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:
- 1 to < 2 years: =< 0.6 mg/dL
- 2 to < 6 years: =< 0.8 mg/dL
- 6 to < 10 years: =< 1 mg/dL
- 10 to < 13 years: =< 1.2 mg/dL
- 13 to < 16 years: =< 1.5 mg/dL (males) and =< 1.4 mg/dL (females)
- >= 16 years: =< 1.7 mg/dL (males) and =< 1.4 mg/dL (females)
- Direct bilirubin < 3.0 mg/dL
- Shortening fraction of >= 27% by echocardiogram, or
- Ejection fraction of >= 50% by radionuclide angiogram
- All patients and/or their parent or legal guardian must sign a written informed
consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met
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Minimum age
1
Year
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Maximum age
31
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
- Patients with Philadelphia chromosome positive/breakpoint cluster region protein
(BCR)-Abelson murine leukemia viral oncogene homolog 1 (ABL1)+ ALL are not eligible
- Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia are not eligible
- Patients with T-lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (T-LL) are not
eligible
- Patients with B-lymphoblastic lymphoma (B-LL) are not eligible
- Patients with known optic nerve and/or retinal involvement are not eligible; patients
who are presenting with visual disturbances should have an ophthalmologic exam and, if
indicated, a magnetic resonance imaging (MRI) to determine optic nerve or retinal
involvement
- Patients known to have one of the following concomitant genetic syndromes: Down
syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome,
Shwachman syndrome or any other known bone marrow failure syndrome
- Patients with known human immunodeficiency virus (HIV) infection
- Patients with known allergy to mitoxantrone, cytarabine, or both etoposide and
etoposide phosphate (Etopophos)
- Lactating females who plan to breastfeed
- Patients who are pregnant since fetal toxicities and teratogenic effects have been
noted for several of the study drugs; a pregnancy test is required for female patients
of childbearing potential
- Sexually active patients of reproductive potential who have not agreed to use an
effective contraceptive method for the duration of their study participation
- Patients with pre-existing significant central nervous system pathology that would
preclude treatment with blinatumomab, including: history of severe brain injury,
dementia, cerebellar disease, organic brain syndrome, psychosis, coordination/movement
disorder, or autoimmune disease with CNS involvement are not eligible; patients with a
history of cerebrovascular ischemia/hemorrhage with residual deficits are not
eligible; (patients with a history of cerebrovascular ischemia/hemorrhage remain
eligible provided all neurologic deficits have resolved)
- Patients with uncontrolled seizure disorder are not eligible; (patients with seizure
disorders that do not require antiepileptic drugs, or are well controlled with stable
doses of antiepileptic drugs remain eligible)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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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
17/12/2014
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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
22/09/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
669
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Princess Margaret Hospital for Children - Perth
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Recruitment hospital [2]
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Perth Children's Hospital - Perth
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Recruitment postcode(s) [1]
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6008 - Perth
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Recruitment postcode(s) [2]
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6009 - Perth
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Recruitment outside Australia
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Funding & Sponsors
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Government body
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Name
National Cancer Institute (NCI)
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Ethics approval
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Summary
Brief summary
This randomized phase III trial studies how well blinatumomab works compared with standard
combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that
has returned after a period of improvement (relapsed). Immunotherapy with blinatumomab may
allow the body's immune system to attack and destroy some types of leukemia cells. It is not
yet known whether blinatumomab is more effective than standard combination chemotherapy in
treating relapsed B-cell acute lymphoblastic leukemia.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02101853
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Public notes
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Contacts
Principal investigator
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Patrick A Brown
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Children's Oncology Group
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02101853
Download to PDF