Clinical trial · Interventional
Study of Ibrutinib & Obinutuzumab With/Without CHOP for Richter's Transformation or Richter's Syndrome Patients
Two-arm Phase II Trial Exploring the Use of the Targeted Agents Ibrutinib and Obinutuzumab for the Treatment of Patients With a Diagnosis of Richter's Transformation (RT) or Richter's Syndrome (RS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Investigator decision to close study
Summary
Brief summary (as posted)
This research study studies the combination of ibrutinib and obinutuzumab with or without the standard chemotherapy regimen of CHOP to see how well these drugs work in treating patients with a diagnosis of Richter's Transformation or Richter's Syndrome. The Bruton's Tyrosine Kinase (BTK) inhibitor, ibrutinib, may stop growth of cancer cells by blocking the signal needed for cell growth. The monoclonal antibody obinutuzumab may block cancer growth by targeting cells present in Richter's Transformation. Giving ibrutinib with obinutuzumab may be a better treatment for patients with Richter's Transformation. Depending on fitness, the patients may receive ibrutinib and obinutuzumab in combination with a regimen known as CHOP (C= cyclophosphamide, H= hydroxydaunorubicin (also called doxorubicin), O= oncovin (also called vincristine, and P= prednisolone or prednisone (corticosteroids).
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 |
|---|---|---|---|
| Richter Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CHOP | Other | — | UNRESOLVED |
| Ibrutinib | Drug | Ibrutinib | ALIAS |
| Obinutuzumab | Drug | Obinutuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fit arm
- description
- ibrutinib and obinutuzumab in combination with the CHOP regimen
- interventionNames
- Drug: Obinutuzumab
- Drug: Ibrutinib
- Other: CHOP
- type
- EXPERIMENTAL
- label
- Frail arm
- description
- ibrutinib and obinutuzumab
- interventionNames
- Drug: Obinutuzumab
- Drug: Ibrutinib
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * confirmed Richter's transformation in treatment naïve and previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma patients * may have had prior exposure to ibrutinib and other B-cell signaling receptor agents * Adequate hematologic function * Adequate liver and kidney function * Willing and able to participate in all required evaluations and procedures in this study protocol * Female subjects of childbearing potential must not be pregnant upon study entry * Male and female subjects who agree to use highly effective methods of birth control Exclusion Criteria: * known allergy to any of medications * chemotherapy taken within 21 days of study treatment * targeted therapy within 10 days of study treatment * BCR inhibitors within 24 hours of study treatment * major surgery within 4 weeks of first dose of study treatment * women who are pregnant * known infection with HIV or Hepatitis C * Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug
References
Publications (0)
Data not yet available