Clinical trial · Interventional
A Study of Duvelisib in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)
A Two-arm, Phase 1b/2 Study of Duvelisib Administered in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)
NCT02391545CI-TRIAL-00070012terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor is focusing on studies which can enable registration of duvelisib.
Summary
Brief summary (as posted)
A Two-arm, Phase 1b/2 Study of duvelisib Administered in Combination with Rituximab or Obinutuzumab in Subjects with Previously Untreated CD20+ Follicular Lymphoma.
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 |
|---|---|---|---|
| CD20+ Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Duvelisib | Drug | Duvelisib | ALIAS |
| Obinutuzumab | Drug | Obinutuzumab | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Duvelisib and Rituximab
- description
- Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
- interventionNames
- Drug: Duvelisib
- Drug: Rituximab
- type
- EXPERIMENTAL
- label
- Duvelisib and Obinutuzumab
- description
- Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
- interventionNames
- Drug: Duvelisib
- Drug: Obinutuzumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of CD20+, follicular lymphoma that has not been treated * CD20-immunophenotyping of tumor to document B-cell follicular lymphoma * Stage II disease with bulky disease (≥ 7cm lesion), Stage III, or Stage IV disease * Disease that requires treatment based on the Investigator's opinion (e.g., meets GELF criteria) * At least one measurable lesion that is \> 1.5 cm in at least one dimension * Eastern Cooperative Oncology Group (ECOG) performance status \<=2 (corresponds to Karnofsky Performance Status \[KPS\] \>=60%) Exclusion Criteria: * Received systemic treatment for lymphoma such as chemotherapy, immunotherapy, radiotherapy, investigational agents, or radioimmunotherapy. * Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3B follicular lymphoma * Severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine protein, or known hypersensitivity to any of the study drugs * Prior allogeneic hematopoietic stem cell transplant * Prior, current or chronic hepatitis B or hepatitis C infection * Human immunodeficiency virus (HIV) infection or Human T Cell Lymphotropic Virus 1 (HTLV-1) infection
References
Publications (0)
Data not yet available
No reference posted for this study.