Ibrutinib + Venetoclax in Untreated WM

  • STATUS
    Recruiting
  • End date
    Jun 1, 2029
  • participants needed
    50
  • sponsor
    Dana-Farber Cancer Institute
Updated on 8 July 2020
cancer
measurable disease
neutrophil count
ibrutinib

Summary

This study evaluates the safety and efficacy of Ibrutinib combined with Venetoclax (IVEN) in the treatment of adults diagnosed with Waldenstrom's macroglobulinemia (WM) cancer with a specific MYD88 gene mutation.

This research study involves an experimental drug combination of targeted therapies.

The names of the study drugs involved in this study are:

  • Venetoclax
  • ibrutinib

Description

  • This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
    • The names of the study drugs involved in this study are:
    • Venetoclax
    • ibrutinib
    • The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
    • Participants will be on the research study for up to 2 years on combined venetoclax and ibrutinib and 4 years of follow-up .
    • It is expected that about 50 people will take part in this research study.
    • The U.S. Food and Drug Administration (FDA) has not approved venetoclax for your specific disease but it has been approved for other uses.

-- Venetoclax is a targeted therapy that blocks BCL-2, a protein that is important for the survival of WM cells. Laboratory studies and early clinical data have shown that the investigational new agent, venetoclax, may kill cancer cells and may cause tumors to shrink.

  • The U.S. Food and Drug Administration (FDA) has approved ibrutinib as a treatment option for this disease.

--Ibrutinib is a targeted therapy that blocks BTK. It has been FDA approved in chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), chronic graft vs. host disease (cGVHD), and Waldenstrom's macroglobulinemia (WM). It is also used in research studies in participants with recurrent B-cell lymphoma), diffuse large B-cell lymphoma (DLBCL), and prolymphocytic leukemia. In a study of ibrutinib in relapsed/refractory WM patients, response rates were high and the treatment was well tolerated.

  • The U.S. Food and Drug Administration (FDA) has not approved the combination of ibrutinib and venetoclax as a treatment for any disease.
  • The U.S. Food and Drug Administration (FDA) has not approved the MYD88 test. This test is investigational.

Details
Treatment Ibrutinib, venetoclax
Clinical Study IdentifierNCT04273139
SponsorDana-Farber Cancer Institute
Last Modified on8 July 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: MYD88 Gene Mutation or Waldenstrom Macroglobulinemia or Lymphoproliferative Disorder or Waldenstrom's Macroglobulinemia or Lymphoproliferative disorde...?
Participants must meet the following criteria on screening examination to be eligible to participate. Screening evaluations including consent, physical exam, and laboratory assessments will be done within 30 days prior to Cycle 1 Day 1. Bone marrow biopsy & aspirate, and CT C/A/P will be done within 90 days prior to Cycle 1 Day 1
Clinicopathological diagnosis of Waldenstrm macroglobulinemia [28]
Known tumor expression of mutated MYD88 performed by a CLIA certified laboratory
Symptomatic disease meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrm macroglobulinemia [29]
Participants with symptomatic hyperviscosity (e.g. nosebleeds, headaches, blurred vision) must undergo plasmapheresis prior to treatment initiation
Age 18 years
ECOG performance status 2 (see Appendix A)
Measurable disease, defined as presence of serum immunoglobin M (IgM) with a minimum IgM level of >2 times the upper limit of normal of each institution is required
At the time of screening, participants must have acceptable organ and marrow function as defined below
Absolute neutrophil count 500/uL (no growth factor permitted)
Platelets 50,000/uL (no platelet transfusions permitted)
Hemoglobin 7 g/dL (transfusions permitted)
Total bilirubin < 1.5 x institutional ULN
AST(SGOT)/ALT(SGPT) 2.5 institutional ULN
Estimated GFR 30 mL/min
Females of childbearing potential (FCBP) must use one reliable form of contraception or have complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) while participating in the study; and 2) for at least 90 days after discontinuation from the study. FCBP must be referred to a qualified provider of contraceptive methods if needed. FCBP must have a negative serum pregnancy test at screening
Men must agree to use a latex condom during treatment and for up to 90 days after the last dose of ibrutinib or venetoclax during sexual contact with a FCBP
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study
Participants who have one or more prior systemic therapies for WM
Participants who are receiving any other investigational agents
Participants with known CNS lymphoma
Participants with known history of Human Immunodeficiency Virus (HIV), chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring active treatment. Note: Participants with serologic evidence of prior vaccination to HBV (i.e., HBs Ag-, and anti-HBs+ and anti-HBC-) and positive anti-HBc from IVIG may participate
Concurrent administration of medications or foods that are moderate or strong inhibitors or inducers of CYP3A within 7 days prior to first dose of study drug
Participants with chronic liver disease and hepatic impairment meeting Child-Pugh class C (Appendix B)
Concurrent administration of warfarin
Concurrent systemic immunosuppressant therapy within 21 days of the first dose of study drug
Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug
Recent infection requiring systemic treatment that was completed 14 days before the first dose of the study drug
Known bleeding disorders (e.g., congenital von Willebrand's disease or hemophilia)
History of stroke or intracranial hemorrhage within 6 months prior to enrollment
Major surgery within 4 weeks of first dose of study drug
Malabsorption syndrome or other condition that precludes enteral route of administration
Female participants who are pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 90 days of last dose of study drug
Male participants who plan to father a child while enrolled in this study or within 90 days after the last dose of study drug
Participants with known history of alcohol or drug abuse
Participants with inability to swallow pills
On any active therapy for other malignancies with the exception of topical therapies for basal cell or squamous cell cancers of the skin
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Participants with a history of non-compliance to medical regimens
Participants who are unwilling or unable to comply with the protocol
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