Overview

This trial is active, not recruiting.

Condition mantle cell lymphoma
Treatment r-chop-14r-hidac,followed by rit/hdt/ascr.
Phase phase 1/phase 2
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator GlaxoSmithKline
Start date November 2011
End date November 2017
Trial size 96 participants
Trial identifier NCT01484093, 11-095

Summary

Mantle cell lymphoma (MCL) is a rare and aggressive type of lymphoma, with only about 3,000 cases diagnosed per year. MCL is considered a difficult cancer to treat. This study is being done to better understand how to treat MCL.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
r-chop-14r-hidac,followed by rit/hdt/ascr. HIGH DOSE CHEMOTHERAPY AND AUTOLOGOUS STEM CELL RESCUE (ASCR)Patients admitted to the hospital for high dose chemotherapy. The anticipated length of
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.

Primary Outcomes

Measure
maximum tolerated dose (MTD)
time frame: 1 year
3 year Event Free Survival (EFS)
time frame: 3 years

Secondary Outcomes

Measure
3-year Event Free Survival (EFS)
time frame: 3 years
rates of complete remission (CR)
time frame: 1 year
Determine 3 year overall survival (OS).
time frame: 3 years

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Previously untreated advanced stage mantle cell lymphoma (Clinical stage 2 with abdominal involvement, stage 3 and stage 4). - Histologic diagnosis confirmed by MSKCC pathologist as mantle cell lymphoma with Cyclin D1, or D2 and/or, D3 staining performed. Presence of measurable disease as determined by FDG-PET, CT, endoscopy, colonoscopy, or bone marrow biopsy. - Ages 18-70. - Transplant eligibility as confirmed by the Disease Management Team. - KPS ≥ 70%. Adequate organ function: - WBC ANC ≥ 1000 cells/mcL and platelet count ≥ 100,000 cells/mcL unless felt to be secondary to underlying mantle cell lymphoma at which any count is permissible. - Adequate renal function as determined by Cr < or = to 1.5 mg/dL or 24 hr creatinine clearance ≥ 50 ml/hr - Adequate hepatic function as determined by total bilirubin < or = to 1.5x ULN (unless known Gilbert syndrome) and AST < or = to 5.0x ULN. - Cardiac ejection fraction greater than or equal to 50% as determined by echocardiogram or MUGA. - For patients ≥ age 60, a stress echocardiogram will be required, with same requirements as above. - DLCO greater than or equal to 50% as determined by pulmonary function tests performed prior to initiation of treatment. - Patients with positive Hepatitis B serologies will be treated per institutional guidelines. Exclusion Criteria: - Prior treatment for mantle cell lymphoma, including more than 7 days of steroids, immunotherapy, radioimmunotherapy, or chemotherapy. This does not include patients who have initiated R-CHOP at an outside institution within 2 weeks of enrollment. - Patients using > or = to 10mg/day of steroids for any chronic medical condition - Pregnant or breast-feeding. Note: Pre-menopausal patients must have a negative, serum HCG within 14 days of enrollment,. - HIV positive or Hepatitis C antibody positive.

Additional Information

Official title Sequential Chemo-Radioimmunotherapy Followed by Autologous Transplantation for Patients With Untreated Advanced Stage Mantle Cell Lymphoma: A Phase I/II Trial
Principal investigator Andrew Zelenetz, MD,PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.