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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,934 Previous Clinical Trials

588,714 Total Patients Enrolled

GlaxoSmithKlineIndustry Sponsor

4,751 Previous Clinical Trials

8,067,376 Total Patients Enrolled

Andrew Zelenetz, MD,PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment ongoing for the experimental research?

"Clinicaltrials.gov reports that recruitment for this trial has ended, as the listing was last updated on December 1st 2021. Although it is no longer accepting participants, there are 1724 other trials actively recruiting at present time."

Answered by AI

How many venues is this research project administered in?

"The present clinical trial is being conducted in 5 locations, with Rockville Centre, Sleepy Hollow and Basking Ridge the primary sites. To alleviate travelling burdens on participants, it is advisable to select a nearby medical centre if you are considering enrollment."

Answered by AI

Would I qualify for this research opportunity?

"This medical trial is enrolling a total of 96 patients aged 18 to 70 with mantle cell lymphoma. Essential criteria for eligible candidates include being treatment-naïve, having WBC ANC and platelet counts that meet the minimum thresholds unless felt to be secondary to underlying malignancy, histologic diagnosis confirmation by MSKCC pathologist, measurable disease determined by FDG-PET or CT scan/endoscopy/colonoscopy/bone marrow biopsy, KPS ≥70%, adequate renal function as indicated through creatinine levels and 24 hour creatinine clearance tests, sufficient hepatic functioning evidenced via bilirubin"

Answered by AI

Is there an upper limit on the age of individuals who may participate in this experiment?

"The requirements for this trial necessitates that the patient's age be between 18 and 70. Apart from this specific study, there are 302 other trials catering to minors and 1567 studies targeting those above 65 years of age."

Answered by AI

Recent research and studies

Clinical Lymphoma Myeloma and LeukemiaJournal

Noninvasive Monitoring of Mantle Cell Lymphoma by Immunoglobulin Gene Next-generation Sequencing in a Phase 2 Study of Sequential Chemoradioimmunotherapy Followed by Autologous Stem-cell Rescue

Kumar, Anita, K.S. Bantilan, A.P. Jacob, A. Park, S.F. Schoninger, C. Sauter, G.A. Ulaner, et al.. 2021. “Noninvasive Monitoring of Mantle Cell Lymphoma by Immunoglobulin Gene Next-generation Sequencing in a Phase 2 Study of Sequential Chemoradioimmunotherapy Followed by Autologous Stem-cell Rescue”. Clinical Lymphoma Myeloma and Leukemia. Elsevier BV. doi:10.1016/j.clml.2020.09.007.

clinicaltrials.govStudy

Sequential Chemo-Radioimmunotherapy Followed by Autologous Transplantation for Patients With Untreated Advanced Stage Mantle Cell Lymphoma

2011. "Sequential Chemo-Radioimmunotherapy Followed by Autologous Transplantation for Patients With Untreated Advanced Stage Mantle Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01484093.