Sequential Chemo-Radioimmunotherapy Followed by Autologous Transplantation for Patients With Untreated Advanced Stage Mantle Cell Lymphoma
Status: | Active, not recruiting |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 9/13/2018 |
Start Date: | November 2011 |
End Date: | November 2019 |
Sequential Chemo-Radioimmunotherapy Followed by Autologous Transplantation for Patients With Untreated Advanced Stage Mantle Cell Lymphoma: A Phase I/II Trial
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.
cases diagnosed per year. MCL is considered a difficult cancer to treat. This study is being
done to better understand how to treat MCL.
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.
We found this trial at
5
sites
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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1000 N Village Ave
Rockville Centre, New York 11570
Rockville Centre, New York 11570
(516) 256-3600
Memorial Sloan-Kettering at Mercy Medical Center Memorial Sloan Kettering Cancer Center Rockville Centre provides state-of-the-art...
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701 N Broadway
Sleepy Hollow, New York 10591
Sleepy Hollow, New York 10591
(914) 366-3000
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center Memorial Sloan Kettering Cancer Center Sleepy...
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