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

Northwell Health

Status and phase: Terminated; Phase 2

Conditions: Richter Syndrome

Treatments: Other: CHOP; Drug: Ibrutinib; Drug: Obinutuzumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03145480

16-727

Details and patient eligibility

About

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).

Enrollment: 3 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Fit arm

Experimental group

Description:

ibrutinib and obinutuzumab in combination with the CHOP regimen

Treatment:

Drug: Obinutuzumab

Drug: Ibrutinib

Other: CHOP

Frail arm

Experimental group

Description:

ibrutinib and obinutuzumab

Treatment:

Drug: Obinutuzumab

Drug: Ibrutinib