Sequential Chemo-Radioimmunotherapy Followed by Autologous Transplantation for Patients With Untreated Advanced Stage Mantle Cell Lymphoma: A Phase I/II Trial

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.