Status:
COMPLETED
Sequential Chemo-Radioimmunotherapy Followed by Autologous Transplantation for Patients With Untreated Advanced Stage Mantle Cell Lymphoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Mantle Cell Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 29 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 11 2023
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT01484093
Start Date
November 29 2011
End Date
August 11 2023
Last Update
August 16 2023
Active Locations (5)
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1
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
4
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York, United States