Ibrutinib in Treating Participants With Untreated High Risk Smoldering Mantle Cell Lymphoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 30
Summary
- Conditions
- Mantle Cell Lymphoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT03282396
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Luhua (Michael) Wang M.D. Anderson Cancer Center