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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Mantle Cell Lymphoma

Treatments: Other: R-CHOP-14R-HIDAC,followed by RIT/HDT/ASCR.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01484093

11-095

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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96 participants in 1 patient group

R-CHOP-14R-HIDAC,followed by RIT/HDT/ASCR.

Experimental group

Description:

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.

Treatment:

Other: R-CHOP-14R-HIDAC,followed by RIT/HDT/ASCR.