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

Sponsor
Northwell Health (Other)
Overall Status
Terminated
CT.gov ID
NCT03145480
Collaborator
Pharmacyclics LLC. (Industry)
3
Enrollment
1
Location
2
Arms
15.3
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
parallel assignment based on fitness of participantsparallel assignment based on fitness of participants
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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)
Actual Study Start Date :
Jun 19, 2017
Actual Primary Completion Date :
Sep 28, 2018
Actual Study Completion Date :
Sep 28, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fit arm

ibrutinib and obinutuzumab in combination with the CHOP regimen

Drug: Obinutuzumab
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
Other Names:
  • gazyva

    • Drug: Ibrutinib
    560mg po daily
    Other Names:
  • imbruvica

    • Other: CHOP
    cyclophosphamide, doxorubicin, vincristine, and prednisone
    Other Names:
  • CHOP Regimen

    		•
    Experimental: Frail arm

    ibrutinib and obinutuzumab

    Drug: Obinutuzumab
    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
    Other Names:
  • gazyva

    • Drug: Ibrutinib
    560mg po daily
    Other Names:
  • imbruvica

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Response Rate (ORR) [6 months]

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

    Secondary Outcome Measures

    1. Number of participants with improved hemoglobin and platelet counts. [6 months]

      hematologic improvement

    2. Progression free survival (PFS) [6 months]

      time to progression post treatment of condition

    3. Quality of Life [1 year]

      health-related quality of life using FACIT Fatigue Scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwell Health/CLL Research and Treatment Program New Hyde Park New York United States 11042

    Sponsors and Collaborators

    • Northwell Health
    • Pharmacyclics LLC.

    Investigators

    • Principal Investigator: Jacqueline Barrientos, MD, Northwell Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jacqueline C. Barrientos, MD, Principal Investigator, Northwell Health
    ClinicalTrials.gov Identifier:
    NCT03145480
    Other Study ID Numbers:
    • 16-727
    First Posted:
    May 9, 2017
    Last Update Posted:
    Feb 21, 2019
    Last Verified:
    Feb 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Jacqueline C. Barrientos, MD, Principal Investigator, Northwell Health
    leukemia
    richter
    Additional relevant MeSH terms:
    Syndrome
    Obinutuzumab

    Study Results

    No Results Posted as of Feb 21, 2019