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

NCT03145480 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 16-727
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Richter Syndrome

Keywords

leukemia; richter

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR in subjects treated with combination of ibrutinib and obinutuzumab (with or without CHOP)

  6 months

Secondary Outcomes (3)

• Number of Participants With Improved Hemoglobin and Platelet Counts.

  6 months

• Progression Free Survival (PFS)

  6 months

• To Evaluate Patient-reported Outcome (PRO) of Health-related Quality of Life by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACiT-Fatigue)

  1 year

Study Arms (2)

Fit arm

EXPERIMENTAL

ibrutinib and obinutuzumab in combination with the CHOP regimen

Drug: Obinutuzumab; Drug: Ibrutinib; Other: CHOP

Frail arm

EXPERIMENTAL

ibrutinib and obinutuzumab

Drug: Obinutuzumab; Drug: Ibrutinib

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

Also known as: gazyva

Fit arm; Frail arm

Ibrutinib DRUG

560mg po daily

Also known as: imbruvica

Fit arm; Frail arm

CHOP OTHER

cyclophosphamide, doxorubicin, vincristine, and prednisone

Also known as: CHOP Regimen

Fit arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• Pharmacyclics LLC.: collaborator

Study Sites (1)

Northwell Health/CLL Research and Treatment Program

New Hyde Park, New York, 11042, United States

Location

MeSH Terms

Conditions

Leukemia

Interventions

obinutuzumab; ibrutinib; VAP-cyclo protocol

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Jacqueline Barrientos, MD
• Organization: Northwell Health

jbarrientos@northwell.edu

516-470-4050

Study Officials

• Jacqueline Barrientos, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: parallel assignment based on fitness of participants

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: May 9, 2017
• Study Start: June 19, 2017
• Primary Completion: September 28, 2018
• Study Completion: September 28, 2018
• Last Updated: June 1, 2023
• Results First Posted: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)