Clinical trial · Interventional
A Study of Duvelisib and Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Indolent or Aggressive Non-Hodgkin Lymphoma, Who Have Not Previously Received a Bcl-2 or PI3K Inhibitor
A Phase 1b/2 Study of Duvelisib and Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Indolent or Aggressive Non-Hodgkin Lymphoma, Who Have Not Previously Received a Bcl-2 or PI3K Inhibitor
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study Stopped
Summary
Brief summary (as posted)
This study is designed to assess the safety, pharmacokinetics, drug-drug interactions, and determine the recommended Phase 2 doses of co administered Duvelisib and Venetoclax in participants with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma, or indolent or aggressive non-Hodgkin lymphoma, who have not previously received a Bcl-2 or Phosphoinositide 3-kinase (PI3K) inhibitor. The Phase 2 portion of the study will preliminarily evaluate efficacy, and expand the toxicity evaluation.
Conditions
Conditions (3)
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 |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Duvelisib | Drug | Duvelisib | ALIAS |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Duvelisib+Venetoclax
- interventionNames
- Drug: Duvelisib
- Drug: Venetoclax
Primary outcomes (9)
- measure
- Number of participants with adverse events
- timeFrame
- From participant's first dose until 30 days after participant's last dose of study drug; up to 2 years following last participant first dose
- description
- Participants will be monitored for clinical and laboratory evidence of adverse events throughout the study.
- measure
- Maximum observed plasma concentration (Cmax) of duvelisib
- timeFrame
- Blood samples will be taken at 0 (pre-dose) 1,2,4,6,8,10 and 12 hours post-dose on Cycle 1 Day 14 and Day 22 for second and third dose levels.
- description
- The highest concentration that a drug achieves in the blood after administration in a dosing interval.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: - Subject must have either • Relapsed or refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (for Waves 2 or 3) * Subject has evaluable disease and requires treatment in the opinion of the investigator. * Subject must have relapsed following or be refractory to ≥ 1 standard treatments such as fludarabine based regimens (F, FC, FR, FCR), alkylator (chlorambucil, bendamustine) based regimens, or Bruton's Tyrosine Kinase inhibitor (Ibrutinib). Or • Relapsed or refractory indolent Non-Hodgkin Lymphoma or aggressive Non-Hodgkin Lymphoma (for Waves 1, 2, or 3, unless otherwise indicated) * Subject must have histologically documented diagnosis of a Follicular Lymphoma or Marginal Zone Lymphoma. * Subject must have histologically documented diagnosis of a Diffuse Large B-cell Lymphoma (excluding Richter's Transformation), Non-cutaneous T-Cell Lymphoma, or Mantle Cell Lymphoma (MCL) (MCL Wave 3 only) * Subject has evaluable disease and requires treatment in the opinion of the investigator. * Subject must have relapsed following or be refractory to ≥ 1 standard treatments such as R-CHOP, R-CVP, bendamustine, lenalidomide-rituximab, or fludarabine-based regimens. * Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2. * 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. * NHL subjects who have a history of an autologous stem cell transplant (e.g., bone marrow) must be \> 6 months post-transplant (prior to the first dose of study drug) and must not require any growth factor support. Exclusion Criteria: * Subject has been previously treated with a Bcl-2 or PI3K inhibitor. * Subject is a candidate to receive another second-line therapy approved for usage by the local Health Authority. * Subject is appropriate for a stem cell transplant or has undergone an allogeneic stem cell transplant. * Subject has received any of the following within 14 days or 5 drug half-lives (whichever is shortest) prior to the first dose of duvelisib or venetoclax, 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 or radiotherapy; * Investigational therapy, including targeted small molecule agents. * Subject has received biologic agents (e.g., monoclonal antibodies) for anti-neoplastic treatment within 30 days prior to first dose of duvelisib or venetoclax. * Subject has received live or live attenuated vaccines within 6 weeks prior to first dose of duvelisib or venetoclax. * Subject has received the following within 7 days prior to the first dose of duvelisib or venetoclax: * Steroid therapy for anti-neoplastic treatment; * Strong and Moderate CYP3A inhibitors; * Strong and Moderate CYP3A inducers; * Chronic immunosuppressants, other than corticosteroids given at daily dose \< 20 mg prednisone equivalent for ITP or AIHA.
References
Publications (0)
Data not yet available