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

Completed · Phase 1/Phase 2

Conditions studied: Mantle Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT01484093

Run by

Memorial Sloan Kettering Cancer Center

People needed

96

Starts

2011-11-29

Expected to finish

2023-08-11

Last updated by the study team

2023-08-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Memorial Sloan Kettering at Basking Ridge — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Cancer Center @ Suffolk — Commack, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• 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

Full record on ClinicalTrials.gov

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