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

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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.


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
1000 N Village Ave
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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Rockville Centre, NY
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Basking Ridge, New Jersey 07920
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Basking Ridge, NJ
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Commack, NY
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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701 N Broadway
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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Sleepy Hollow, NY
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