Sequential Chemo-Radioimmunotherapy Followed by Autologous Transplantation for Patients With Untreated Advanced Stage Mantle Cell Lymphoma
|ClinicalTrials.gov Identifier: NCT01484093|
Recruitment Status : Active, not recruiting
First Posted : December 2, 2011
Last Update Posted : September 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Mantle Cell Lymphoma||Other: R-CHOP-14R-HIDAC,followed by RIT/HDT/ASCR.||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sequential Chemo-Radioimmunotherapy Followed by Autologous Transplantation for Patients With Untreated Advanced Stage Mantle Cell Lymphoma: A Phase I/II Trial|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
Experimental: R-CHOP-14R-HIDAC,followed by RIT/HDT/ASCR.
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.
Other: R-CHOP-14R-HIDAC,followed by RIT/HDT/ASCR.
INDUCTION: R-CHOP-14 CHEMOTHERAPY: 4 cycles every 2 weeks ± 1 day All patients in the study in both phases will undergo induction and consolidation with R-CHOP 14R-HIDAC, followed by RIT/HDT/ASCR. Patients will undergo restaging scans 12 to 14 days following completion of R-CHOP 14, with CT, and FDG-PET. Patients demonstrating at least a PR may proceed to consolidation with R-HIDAC. CONSOLIDATION: R- HIDAC CHEMOTHERAPY: 2 cycles every 3 weeks ± 2 days After R-HIDAC, restaging will occur 17-21 days post cycle 2 with CT scan (or FDG-PET, if this was positive following R-CHOP-14). Radioimmunotherapy Dosimetric dose is given approximately 4-5 weeks after completing cycle 2 of R-HIDAC. This is to be preferred 1 week post restaging scans 17-21 days post cycle 2 of RHIDAC, and up to 2 weeks post-scans will be acceptable only if required by 131 I Tositumomab availability.
- maximum tolerated dose (MTD) [ Time Frame: 1 year ]of HIDAC. For this study the MTD will be the dose at which no more than one grade 3 CNS toxic event (defined by CTCAE 4.0 as severe neurologic symptoms limiting self care ADLs') up to two weeks following HIDAC occurs among a 6 patient cohort. Phase I
- 3 year Event Free Survival (EFS) [ Time Frame: 3 years ]from 67% (historical control) to 80 % in all patients. The EFS interval starts at enrollment date, and an event is defined as death from any cause or progression of disease. Patients who have completed the ASCT but elect to be removed from the study or lost to follow-up by the end of the third year will be counted as events as well. Phase II
- 3-year Event Free Survival (EFS) [ Time Frame: 3 years ]in subsets of patients with Ki-67 ≥ 30%
- rates of complete remission (CR) [ Time Frame: 1 year ]as defined by CT, FDG-PET and histology
- Determine 3 year overall survival (OS). [ Time Frame: 3 years ]Defined as last known follow up or date of death - date of diagnosis.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01484093
|United States, New Jersey|
|Memorial Sloan Kettering at Basking Ridge|
|Basking Ridge, New Jersey, United States, 07920|
|United States, New York|
|Memorial Sloan Kettering Cancer Center @ Suffolk|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan Kettering at Mercy Medical Center|
|Rockville Centre, New York, United States|
|Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center|
|Sleepy Hollow, New York, United States, 10591|
|Principal Investigator:||Andrew Zelenetz, MD,PhD||Memorial Sloan Kettering Cancer Center|