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

Part of paid clinical trials in New Hyde Park, New York.

Sponsor
Northwell Health
Study ID
NCT03145480
Phase
PHASE2
Status
Terminated

Conditions

  • Richter Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Obinutuzumab — DRUG
    100 mg on day 1 and 900 mg on day 2 Cycle 1, 1000 mg on day 8 and 15 of Cycle 1, and 1000 mg on day 1 of Cycles 2-6
  • Ibrutinib — DRUG
    560mg po daily
  • CHOP — OTHER
    cyclophosphamide, doxorubicin, vincristine, and prednisone

Study Details

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).

Key Dates

Start date
Jun 19, 2017
Status verified
May 2023
Primary completion
Sep 28, 2018
Completion
Sep 28, 2018

Study Design

Enrollment
3 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fit arm
    ibrutinib and obinutuzumab in combination with the CHOP regimen
  • Experimental: Frail arm
    ibrutinib and obinutuzumab

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Northwell Health/CLL Research and Treatment ProgramNew Hyde ParkNew York11042-

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Northwell Health/CLL Research and Treatment Program· New Hyde Park, NY

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