A Phase 1 interventional study of ABT-199 and Rituximab in Small Lymphocytic Lymphoma and Chronic Lymphocytic Leukemia, sponsored by AbbVie. Completed at 6 sites in 2 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-06-06.
Sponsored by AbbVie · Phase 1, Interventional, and Treatment
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 49 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
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Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
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Exclusion Criteria:
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:
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:
Subject exhibits evidence of other clinically significant ongoing or recent condition(s) including, but not limited to:
Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)
Drug: ABT-199 · Drug: Rituximab
ABT-199 is taken continuously once daily. This is a dose escalation study, therefore the dose of ABT-199 will change throughout the study.
Also known as: venetoclax
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.
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.
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.
Time frame: 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.
Determination of peak concentration (Cmax) of ABT-199 and/or Rituximab.
Blood samples for analysis of ABT-199 and rituximab will be collected at designated time points.
Time frame: PK samples collected up to Month 6 for ABT-199 and Rituximab
Assess the exploratory efficacy of the combination ABT-199 and rituximab.
Tumor response or clinical disease progression (Objective Response Rate)
Time frame: 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.
Determination of trough concentration (Ctrough) of ABT-199 and/or Rituximab
Blood samples for analysis of ABT-199 and rituximab will be collected at designated time points.
Time frame: PK samples collected up to Month 6 for ABT-199 and Rituximab
Determination of area under the concentration versus time curve (AUC) of ABT-199 and/or Rituximab
Blood samples for analysis of ABT-199 and rituximab will be collected at designated time points.
Time frame: PK samples collected up to Month 6 for ABT-199 and Rituximab
Assess the exploratory efficacy of the combination ABT-199 and rituximab
Tumor response or clinical disease progression for (Overall Survival)
Time frame: 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.
Assess the exploratory efficacy of the combination ABT-199 and rituximab
Tumor response or clinical disease progression for (Progression Free Survival)
Time frame: 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.
Assess the exploratory efficacy of the combination ABT-199 and rituximab
Tumor response or clinical disease progression for (Time to Tumor Progression)
Time frame: 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.
Assess the exploratory efficacy of the combination ABT-199 and rituximab
Tumor response or clinical disease progression for (Duration Of Response)
Time frame: 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.
Assess the exploratory pharmacodynamics and pharmacogenetics of the combination of ABT-199 and rituximab.
Minimal residual disease (MRD) will be assessed in the peripheral blood and bone marrow (BM) either by flow cytometry or real-time PCR.
Time frame: MRD Assessments will be performed at following timepoints: At least 2 months after CR/CRi criteria for tumor response first met, every 12 weeks thereafter until MRD negativity is achieved, and as needed.
Plan to share: No
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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