Ibrutinib in Treating Participants With Untreated High Risk Smoldering Mantle Cell Lymphoma

  • STATUS
    Recruiting
  • participants needed
    20
  • sponsor
    M.D. Anderson Cancer Center
Updated on 15 August 2022
platelet count
cancer
remission
measurable disease
cytopenia
TP53
neutrophil count
tumor cells
mantle cell lymphoma
ibrutinib
cyclin d1
bone marrow infiltration

Summary

This phase II trial studies how well ibrutinib works in treating participants with untreated high risk smoldering mental cell lymphoma. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Description

PRIMARY OBJECTIVE:

I. To measure the progression-free survival (PFS) in previously untreated high-risk smoldering mental cell lymphoma (MCL) patients treated with ibrutinib.

SECONDARY OBJECTIVES:

I. To evaluate the safety of ibrutinib in previously untreated high risk smoldering MCL.

II. To evaluate the response rate and duration of response of ibrutinib. III. To study clonal evolution in MCL while under ibrutinib.

EXPLORATORY OBJECTIVES:

I. To collect serial samples for our correlative study (plasma, peripheral blood mononuclear cells [PBMC], initial tumor biopsy).

OUTLINE

Participants receive ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days for 5 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up every 2 months for 6 months, every 2-4 months for 2 years, then every 4-6 months thereafter.

Details
Condition Lymphoma, Non-Hodgkin's Lymphoma, Mantle cell lymphoma, Mantle cell lymphoma, Non-Hodgkin's Lymphoma
Treatment Ibrutinib
Clinical Study IdentifierNCT03282396
SponsorM.D. Anderson Cancer Center
Last Modified on15 August 2022

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