Rituximab in Addition to Autologous Transplantation With BEAM for Patients With Lymphoid Malignancies
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring Non-Hodgkin's Lymphoma, Lymphoid Malignancies, Lymphoma, BEAM Chemotherapy, Carmustine, BCNU, BiCNU, Etoposide, VePesid, Cytarabine, Cytosar, DepoCyt, Cytosine arabinosine hydrochloride, Ara-C, Melphalan, Rituximab, Rituxan
Eligibility Criteria
Inclusion Criteria:
- Patients with histologically proven diffuse large B-cell (CD20 positive) or transformed follicular non-Hodgkin's lymphomas, that have relapsed after conventional chemotherapy and are not eligible for protocols of higher priority
- Patients must have chemosensitive disease to salvage chemotherapy and less than 5% bone marrow involvement with lymphoma by gross pathologic examination
- Age less than or equal to 80 years. There is no lower age limit for this study.
- Zubrod performance status of less than 2
- Negative pregnancy test in patients with child bearing potential
- Must be willing to sign informed consent
- Should be seronegative for HIV, hepatitis B surface antigen, hepatitis C antibody.
Exclusion Criteria:
- Patients with known active CNS disease are excluded. Patients with prior history of CNS disease should have a negative MRI of the brain (and/or spine if indicated) and negative CSF cytology within 4 weeks of enrollment into the study.
- Less than 3 weeks from last cytotoxic chemotherapy
- Serum bilirubin > 1.5 mg/dl
- Serum transaminases > 2X/ULN
- Serum creatinine > 1.6 mg/dl
- Failure to collect more than 3 x 1,000,000 CD34+ stem cells/kg body weight
- Left ventricular ejection fraction of < 40%, unless cleared by cardiology
- Corrected DLCO of < 50%
- Patients who are on anticoagulants or antiplatelet agents.
Sites / Locations
- UT MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
BEAM + Standard Rituximab
BEAM + High Rituximab
Arm 1 BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Rituximab with Standard Rituximab for Cohort 1 or 2 Cohort 1 for 65 years of age or younger BEAM: Carmustine 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), and melphalan 140 mg/m2 IV on day -1. Cohort 2 for older than 65 years of age BEAM: Carmustine 300 mg/m2 IV over 1 hour on day -6, cytarabine 100 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), etoposide 100 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), and melphalan 140 mg/m2 IV on day -1. Standard Rituximab: 375 mg/m^2 IV Days +1, +8 after Stem Cell Infusion on Day 0.
BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab Cohort 1 for 65 years of age or younger BEAM: Carmustine 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), and melphalan 140 mg/m2 IV on day -1. Cohort 2 for older than 65 years of age BEAM: Carmustine 300 mg/m2 IV over 1 hour on day -6, cytarabine 100 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), etoposide 100 mg/m2 IV twice a day on days -5 through -2 (total 8 doses), and melphalan 140 mg/m2 IV on day -1. High Dose Rituximab: 1000 mg/m^2 IV Days +1, +8 after Stem Cell Infusion on Day 0