Ibrutinib + Venetoclax in Untreated WM

STATUS

Recruiting
End date

Jun 1, 2029
participants needed

50
sponsor

Dana-Farber Cancer Institute

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Updated on 19 February 2024

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cancer

absolute neutrophil count

serum pregnancy test

measurable disease

neutrophil count

growth factor

waldenstrom's macroglobulinemia

ibrutinib

platelet transfusion

bone marrow biopsy

venetoclax

igm level

plasmapheresis

myd88 gene mutation

Summary

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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

Condition	Waldenstrom's Macroglobulinemia, Lymphoproliferative Disorder, MYD88 Gene Mutation
Age	18years - 100years
Treatment	Venetoclax, Ibrutinib
Clinical Study Identifier	NCT04273139
Sponsor	Dana-Farber Cancer Institute
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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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Ibrutinib + Venetoclax in Untreated WM