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Chemotherapy
R-CHOP-14R-HIDAC,followed by RIT/HDT/ASCR. for Mantle Cell Lymphoma
Phase 1 & 2
Waitlist Available
Led By Andrew Zelenetz, MD,PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is studying how well ibrutinib works in treating patients with mantle cell lymphoma.
Eligible Conditions
- Mantle Cell Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
3 year Event Free Survival (EFS)
maximum tolerated dose (MTD)
Secondary outcome measures
3-year Event Free Survival (EFS)
Determine 3 year overall survival (OS).
rates of complete remission (CR)
Trial Design
1Treatment groups
Experimental Treatment
Group I: R-CHOP-14R-HIDAC,followed by RIT/HDT/ASCR.Experimental Treatment1 Intervention
This is a phase I/phase II multi-institution trial. The phase I part of the trial will determine the MTD of cytarabine. The phase II part of the trial will examine the efficacy of the proposed regimen by evaluating the 3-year event-free survival (EFS) in patients with untreated mantle cell lymphoma. All patients in the study in both phases will undergo induction and consolidation with R-CHOP 14R-HIDAC, followed by RIT/HDT/ASCR.
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,940 Previous Clinical Trials
588,815 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,766 Previous Clinical Trials
8,105,490 Total Patients Enrolled
Andrew Zelenetz, MD,PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
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