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

NCT03282396 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2016-0914NCI-2018-01045
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test.

  Up to 3.5 years

Secondary Outcomes (4)

• Incidence of adverse events

  Up to 3.5 years

• Response rate of ibrutinib

  Up to 3.5 years

• Response duration

  Up to 3.5 years

• Overall survival

  Up to 3.5 years

Study Arms (1)

Treatment (ibrutinib)

EXPERIMENTAL

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

Drug: Ibrutinib

Interventions

Ibrutinib DRUG

Given PO

Also known as: BTK Inhibitor PCI-32765, CRA-032765, Imbruvica, PCI-32765

Treatment (ibrutinib)

Eligibility Criteria

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

You may qualify if:

• Confirmed diagnosis of MCL with CD20 and cyclin D1 positivity or cyclin D1 negative MCL classic histology in tissue biopsy. Patients must have never received any prior therapy for their disease. Patients have been observed for 3 - 6 months with no progression as per imaging assessments
• High risk smoldering MCL (i.e. patients without any B symptoms or any symptoms related to MCL warranting immediate systemic therapy) with at least one or more of these eligibility criteria:
• Ki-67 of 15-30% (Ki-67% from involved tissue not bone marrow \[BM\], unless confirmed by pathologist),
• White blood cells (WBC) 15-30k
• Lymph node size 3-5 cm in diameter
• Complex karyotype
• TP53 mutated or wild type and/or del17p (fluorescence in situ hybridization \[FISH\]% 10-50%)
• MYC positive MCL. MYC positive (either by FISH or by immunohistochemistry \[IHC\] and confirmed by pathology at MD Anderson Cancer Center \[MDACC\])
• Presence of either or KMT2D, BIRC3, NOTCH2, NSD2 or more than one mutation in the initial next generation sequencing (NGS) panel testing are allowed
• Understand and voluntarily sign an institutional review board (IRB)-approved informed consent form
• Age \>= 18 years at the time of signing the informed consent
• Patients should in general have bi-dimensional measurable disease with their biggest tumor less than or equal to 5 cm. (Bone marrow or gastrointestinal \[GI\] only involvement is acceptable)
• Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
• Cardiology clearance is required. Discussion with cardiologist and co-principal investigator (PI) is required before starting ibrutinib
• With minimal disease or absent disease related symptoms but anxious to start systemic therapy

You may not qualify if:

• Any serious medical condition including but not limited to uncontrolled hypertension, arrhythmias, diabetes mellitus, active/symptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), renal failure, very painful, intolerable symptoms from splenomegaly, leukemic features, active hemorrhage, or psychiatric illness that, in the investigator's opinion, places the patient at unacceptable risk and would prevent the subject from signing the informed consent form
• Patients with ANY of the following risk factors:
• Clinically significant disease related symptoms (including significant B symptoms) compromising the performance status to more than 1
• Blastoid variant histology
• Pleomorphic variant histology
• Ki-67 \> 30%
• Bulky tumors \> 5 cm
• Central nervous system (CNS) involvement at diagnosis
• All patients must not have received any prior treatment for mantle cell lymphoma
• Prior exposure to BTK inhibitor
• Pregnant or breastfeeding females
• Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV). Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded
• All patients with history of central nervous system lymphoma
• History of stroke or intracranial hemorrhage within 6 months prior to signing the consent
• Currently active, or past history/of clinically significant cardiovascular disease such as uncontrolled arrhythmia or any Class 3 or 4 congestive heart failure as defined by the New York Heart Association Classification, or even controlled arrhythmias (any grade) on medications or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Luhua (Michael) Wang

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 13, 2017
• Study Start: June 8, 2020
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

US (1)