drugset / Trial / NCT03145480

Study of Ibrutinib & Obinutuzumab With/Without CHOP for Richter's Transformation or Richter's Syndrome Patients

NCT03145480 ↗

Phase 2 Terminated 3 enrolled Northwell Health Pharmacyclics LLC. · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2017-06-19
Primary completion
2018-09-28
Completion
2018-09-28

Outcome

Outcome not reported

Stopped: “Investigator decision to close study”

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibrutinib Small molecule 560 mg Oral
Subject Obinutuzumab Monoclonal antibody 1000 mg —