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
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials