Clinical trial · Interventional
An Extension Study of ABT-199 in Subjects With Advanced Non-Hodgkin's Lymphoma
An Extension Study of Venetoclax in Subjects With Advanced Non-Hodgkin's Lymphoma
NCT01969695CI-TRIAL-00042421completedPhase 1ClinicalTrials.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)
This is a Phase 1, open-label, multicenter, extension study. Subjects with non-Hodgkin's lymphoma (NHL) (excluding chronic lymphocytic lymphoma \[CLL\], small lymphocytic lymphoma \[SLL\], and mantle cell lymphoma \[MCL\]) who completed a prior ABT-199 study, or were active and assigned to ABT-199 when the study was completed, may roll over into this extension study. Subjects will receive ABT-199 during this study.
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 |
|---|---|---|---|
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABT-199 | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ABT-199
- description
- ABT-199 monotherapy
- interventionNames
- Drug: ABT-199
Primary outcomes (5)
- measure
- Change in cardiac assessment findings
- timeFrame
- Measured from Day 1 up to 6 years after the last subject has enrolled in the study
- description
- Electrocardiogram and Multi Gated Acquisition Scan and/or Echocardiogram
- measure
- Percentage of subjects with adverse events
- timeFrame
- Measured up to 6 years after the last subject has enrolled in the study
- description
- Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Subject has completed a prior ABT-199 study (and had met the criteria for a diagnosis of NHL and all other eligibility criteria for the previous study) and the investigator believes that treatment with ABT-199 is in the best interest of the subject. Exclusion Criteria: * Subject discontinued ABT-199 administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other). * Subject has any medical condition that in the opinion of the investigator places the subject at an unacceptably high risk for toxicities. * Subject has not recovered to ≤ Grade 2 clinically significant adverse effect(s)/toxicity(ies) of previous therapy. * Subject has been diagnosed with Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or mantle cell lymphoma (MCL).
References
Publications (0)
Data not yet available
No reference posted for this study.