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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/NCT01682616
Registration number
NCT01682616
Ethics application status
Date submitted
26/06/2012
Date registered
11/09/2012
Date last updated
6/06/2023
Titles & IDs
Public title
A Phase 1b Study Evaluating the Safety and Tolerability of ABT-199 in Combination With Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
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Scientific title
A Phase 1b Study Evaluating the Safety and Tolerability of ABT-199 in Combination With Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
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Secondary ID [1]
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M13-365
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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:
Small Lymphocytic Lymphoma
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Chronic Lymphocytic Leukemia
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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(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - ABT-199
Treatment: Drugs - Rituximab
Experimental: Arm 1 - Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)
Treatment: Drugs: ABT-199
ABT-199 is taken continuously once daily. This is a dose escalation study, therefore the dose of ABT-199 will change throughout the study.
Treatment: Drugs: Rituximab
Rituximab will be given by intravenous infusion on day 1 of Months 1, 2, 3, 4, 5, and 6. May be reinitiated for an additional 6 months.
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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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Assess the safety profile, to determine the maximum tolerated dose and Recommended Phase Two Dose of ABT-199 when administered in combination with rituximab (R) in subjects with relapsed chronic lymphocytic leukemia and small lymphocytic lymphoma.
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Assessment method [1]
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Protocol-defined events, which are attributed as having a reasonable possibility of being related to the administration of ABT-199 and/or rituximab, or can not be attributed by the investigator to a clearly identifiable cause such as tumor progression, concurrent illness, underlying disease or concomitant medication, will be considered a dose limiting toxicity.
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Timepoint [1]
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Continuous dosing at designated dose level up to Month 6. At end of combination treatment, ABT-199 monotherapy may continue up to 8 years following the date of the last subject enrolled. If disease progression occurs, subjects may re-initiate ABT-199.
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Secondary outcome [1]
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Determination of peak concentration (Cmax) of ABT-199 and/or Rituximab.
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Assessment method [1]
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Blood samples for analysis of ABT-199 and rituximab will be collected at designated time points.
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Timepoint [1]
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PK samples collected up to Month 6 for ABT-199 and Rituximab
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Secondary outcome [2]
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Assess the exploratory efficacy of the combination ABT-199 and rituximab.
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Assessment method [2]
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Tumor response or clinical disease progression (Objective Response Rate)
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Timepoint [2]
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Tumor Assessments will be performed at: Screening, Day 1 on Months 1, 3, 7, and then every 3 months thereafter up to 8 years following the date of the last subject first dose.
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Secondary outcome [3]
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Determination of trough concentration (Ctrough) of ABT-199 and/or Rituximab
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Assessment method [3]
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Blood samples for analysis of ABT-199 and rituximab will be collected at designated time points.
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Timepoint [3]
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PK samples collected up to Month 6 for ABT-199 and Rituximab
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Secondary outcome [4]
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Determination of area under the concentration versus time curve (AUC) of ABT-199 and/or Rituximab
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Assessment method [4]
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Blood samples for analysis of ABT-199 and rituximab will be collected at designated time points.
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Timepoint [4]
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PK samples collected up to Month 6 for ABT-199 and Rituximab
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Secondary outcome [5]
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Assess the exploratory efficacy of the combination ABT-199 and rituximab
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Assessment method [5]
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Tumor response or clinical disease progression for (Overall Survival)
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Timepoint [5]
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Tumor Assessments will be performed at: Screening, Day 1 on Months 1, 3, 7, and then every 3 months thereafter up to 8 years following the date of the last subject first dose.
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Secondary outcome [6]
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Assess the exploratory efficacy of the combination ABT-199 and rituximab
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Assessment method [6]
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Tumor response or clinical disease progression for (Progression Free Survival)
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Timepoint [6]
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Tumor Assessments will be performed at: Screening, Day 1 on Months 1, 3, 7, and then every 3 months thereafter up to 8 years following the date of the last subject first dose.
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Secondary outcome [7]
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Assess the exploratory efficacy of the combination ABT-199 and rituximab
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Assessment method [7]
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Tumor response or clinical disease progression for (Time to Tumor Progression)
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Timepoint [7]
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Tumor Assessments will be performed at: Screening, Day 1 on Months 1, 3, 7, and then every 3 months thereafter up to 8 years following the date of the last subject first dose.
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Secondary outcome [8]
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Assess the exploratory efficacy of the combination ABT-199 and rituximab
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Assessment method [8]
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Tumor response or clinical disease progression for (Duration Of Response)
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Timepoint [8]
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Tumor Assessments will be performed at: Screening, Day 1 on Months 1, 3, 7, and then every 3 months thereafter up to 8 years following the date of the last subject first dose.
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Eligibility
Key inclusion criteria
- Subject must be greater then or equal to 18 years of age.
- Subject must have relapsed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.
- Subject has an Eastern Cooperative Oncology Group performance score of less than or
equal to 1.
- Subject must have adequate bone marrow independent of growth factor support per local
laboratory reference range at Screening.
- Subject must have adequate coagulation, renal, and hepatic function, per laboratory
reference range at Screening.
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Minimum age
18
Years
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Maximum age
99
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
- Chronic lymphocytic leukemia or Small Lymphocytic Lymphoma subject has undergone an
allogeneic or autologous stem cell transplant.
- Subject has uncontrolled autoimmune hemolytic anemia or thrombocytopenia.
- Subject has tested positive for human immunodeficiency virus.
- Seropositivity for hepatitis B surface antigen or hepatitis C virus antibody or
ribonucleic acid.
- History of severe allergic or anaphylactic reactions to rituximab.
- Subject has received a live viral vaccine within 6 months prior to the first dose of
study drug.
- Subject has received a monoclonal antibody for anti-neoplastic intent within 8 weeks
prior to the first dose of study drug.
- Subject has received any of the following within 14 days prior to the first dose of
study drug, or has not recovered to less than grade 2 clinically significant adverse
effect(s)/toxicity(s) of the previous therapy:
- Any anti-cancer therapy including chemotherapy, immunotherapy, or radiotherapy;
- Investigational therapy, including targeted small molecule agents.
- Subject has a cardiovascular disability status of New York Heart Association Class
greater then or equal to 2. Class 2 is defined as cardiac disease in which subjects
are comfortable at rest but ordinary physical activity results in fatigue,
palpitations, dyspnea or anginal pain.
- Subject has a significant history of renal, neurologic, psychiatric, pulmonary,
endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the
opinion of the investigator would adversely affect his/her participating in this
study.
- Subject has a history of other active malignancies other than CLL/SLL within the past
2 years prior to study entry, with the exception of:
- Adequately treated in situ carcinoma of the cervix uteri;
- Basal cell carcinoma of the skin or localized squamous cell carcinoma of the
skin;
- Previous malignancy confined and surgically resected (or treated with other
modalities) with curative intent.
- Subject has malabsorption syndrome or other condition that precludes enteral route of
administration.
- Subject exhibits evidence of other clinically significant ongoing or recent
condition(s) including, but not limited to:
- Ongoing systemic infection (viral, bacterial, or fungal);
- Diagnosis of fever and neutropenia within 1 week prior to study drug
administration
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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 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
25/07/2012
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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
23/06/2022
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Sample size
Target
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Accrual to date
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Final
49
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Peter MacCallum Cancer Ctr /ID# 70394 - Melbourne
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Recruitment hospital [2]
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The Royal Melbourne Hospital /ID# 70393 - Parkville
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Recruitment postcode(s) [2]
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3050 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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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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Illinois
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Country [3]
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United States of America
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State/province [3]
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New York
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Country [4]
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United States of America
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State/province [4]
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North Carolina
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Genentech, Inc.
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase 1b, open-label, multicenter study evaluating the safety and tolerability of
ABT-199 in combination with rituximab in up to 50 subjects with Relapsed Chronic Lymphocytic
Leukemia and Small Lymphocytic Lymphoma. The primary objectives of this study are to assess
the safety profile, to determine the maximum tolerated dose and establish the Recommended
Phase Two Dose of ABT-199 when administered in combination with rituximab. The dose
escalation portion of the study will include approximately 30 subjects. Once the recommended
phase two dose and schedule have been determined, up to 20 additional subjects will be
enrolled in an expanded safety portion of the study. Subjects who meet criteria for CR, CRi,
or MRD-negative PR during the study may discontinue ABT 199. If disease progression occurs,
as defined by iwCLL NCI/WG criteria for tumor response, or MRD progression, subjects may
re-initiate ABT-199.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01682616
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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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 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/NCT01682616
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