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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

November 29, 2011

Primary Completion Date

August 11, 2023

Study Completion Date

August 11, 2023

Conditions
Mantle Cell Lymphoma
Interventions
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.

Trial Locations (5)

10065

Memorial Sloan Kettering Cancer Center, New York

10591

Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center, Sleepy Hollow

11725

Memorial Sloan Kettering Cancer Center @ Suffolk, Commack

07920

Memorial Sloan Kettering at Basking Ridge, Basking Ridge

Unknown

Memorial Sloan Kettering at Mercy Medical Center, Rockville Centre

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT01484093 - Sequential Chemo-Radioimmunotherapy Followed by Autologous Transplantation for Patients With Untreated Advanced Stage Mantle Cell Lymphoma | Biotech Hunter | Biotech Hunter