Clinical trial · Interventional
Open-label Extension Study of Navitoclax in Subjects With Chronic Lymphocytic Leukemia (CLL)
An Extension Study of Navitoclax (ABT-263) in Subjects With Chronic Lymphocytic Leukemia (CLL)
NCT01557777CI-TRIAL-00015006completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Open-label extension study of navitoclax in subjects with chronic lymphocytic leukemia (CLL).
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 |
|---|---|---|---|
| Navitoclax | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Navitoclax, ABT-263
- interventionNames
- Drug: Navitoclax
Primary outcomes (3)
- measure
- Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.
- timeFrame
- Adverse events occuring through the Final Visit (up to Week 52) will be reported
- description
- The investigators will monitor each subject for clinical and lab evidence of adverse events on a routine basis through out the study. The investigators will question each subject regarding any adverse effects that they have experienced and record any events on the care report forms. All adverse events will be followed to a satisfactory clinical resolution.
- measure
- Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety.
- timeFrame
- Change from baseline through Final Visit (up to Week 52).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The subject has been dosing in Arm C of the ABT4710n study, has not discontinued for any reason prior to study closure and the investigator believes that continued treatment with navitoclax is in the best interest of the subject * The subject must meet defined hematology and coagulation lab criteria as specified in the protocol * The subject must meet defined chemistry criteria as specified in the protocol * Women of childbearing potential and men must agree to use adequate contraception (as per protocol) prior to study entry, for the duration of study participation and up to 90 days following completion of therapy * The subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign the Informed Consent Form Exclusion Criteria: * The subject discontinued navitoclax administration in Arm C of the ABT4710n study for reasons of disease progression, Adverse Event toxicity, withdrawal of consent or Investigator decision prior to study completion. * The subject has any medical condition which in the opinion of the investigator places the subject at an unacceptably high risk for toxicities. * The subject is a lactating or pregnant female.
References
Publications (0)
Data not yet available
No reference posted for this study.