Clinical trial · Interventional
A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABT-263 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of ABT-263 under two different dosing schedules with the objective of defining the dose limiting toxicity and maximum tolerated dose. The Phase 2a portion of the study will evaluate ABT-263 at the defined recommended Phase 2 dose to obtain additional safety information and a preliminary assessment of efficacy. The Extension Study portion will allow active subjects to continue to receive ABT-263 for up to 11 years after the last subject transitions with less frequent study evaluations.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABT-263 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (10)
- type
- EXPERIMENTAL
- label
- Navitoclax 14/21 Day Cycle: 10 mg
- description
- Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.
- interventionNames
- Drug: ABT-263
- type
- EXPERIMENTAL
- label
- Navitoclax 14/21 Day Cycle: 110 mg
- description
- Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.
- interventionNames
- Drug: ABT-263
- type
- EXPERIMENTAL
- label
- Navitoclax 14/21 Day Cycle: 200 mg
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Relapsed or refractory CLL and require treatment in opinion of investigator. * Eastern Cooperative Oncology Group (ECOG) \<= 1. * Adequate bone marrow independent of growth factor support, renal and hepatic function per defined laboratory criteria. Exclusion Criteria: * History or is clinically suspicious for cancer-related Central Nervous System disease. * Receipt of allogenic or autologous stem cell transplant. * Recent history (within 1 year of first dose) of underlying, predisposing condition of bleeding or currently exhibits signs of bleeding. * Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis. * Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions (within 1 year of first dose).
References
Publications (1)
- RESULTRoberts AW, Seymour JF, Brown JR, Wierda WG, Kipps TJ, Khaw SL, Carney DA, He SZ, Huang DC, Xiong H, Cui Y, Busman TA, McKeegan EM, Krivoshik AP, Enschede SH, Humerickhouse R. Substantial susceptibility of chronic lymphocytic leukemia to BCL2 inhibition: results of a phase I study of navitoclax in patients with relapsed or refractory disease. J Clin Oncol. 2012 Feb 10;30(5):488-96. doi: 10.1200/JCO.2011.34.7898. Epub 2011 Dec 19. PMID 22184378