Rituximab in Addition to Autologous Transplantation With BEAM for Patients With Lymphoid Malignancies
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: Carmustine; Etoposide; Cytarabine; Melphalan; Rituximab
Intervention description: 300 mg/m^2 IV for 1 Day; Arm 1 = 200 mg/m^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m^2 IV Every 12 Hours x 4 Days; Arm 1 = 200 mg/m^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m^2 IV Every 12 Hours x 4 Days; 140 mg/m^2 IV x 1 Day; Cohort 1, High-Dose Rituximab = 1000 mg/m^2 IV On Days +1 and +8 After Stem Cell Infusion; Cohort 2, Standard Dose Rituximab = 375 mg/m^2 IV On Days +1 and +8 After Stem Cell Infusion.
Intervention MeSH terms: Cytarabine; Rituximab; Etoposide; Melphalan; Carmustine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 93.0
Sex: All
Maximum age: 80 Years
Healthy volunteers: No
Keywords: 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

Summary:

      Cohort 1: Patients who are less than or equal to 65 years of age.

      1. To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose
      rituximab)

      Cohort 2: Patients who are older than 65 years of age

        1. To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high
           dose rituximab)

        2. To determine the treatment related mortality (TRM)
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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

          2. Patients must have chemosensitive disease to salvage chemotherapy and less than 5%
             bone marrow involvement with lymphoma by gross pathologic examination

          3. Age less than or equal to 80 years. There is no lower age limit for this study.

          4. Zubrod performance status of less than 2

          5. Negative pregnancy test in patients with child bearing potential

          6. Must be willing to sign informed consent

          7. Should be seronegative for HIV, hepatitis B surface antigen, hepatitis C antibody.

        Exclusion Criteria:

          1. 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.

          2. Less than 3 weeks from last cytotoxic chemotherapy

          3. Serum bilirubin > 1.5 mg/dl

          4. Serum transaminases > 2X/ULN

          5. Serum creatinine > 1.6 mg/dl

          6. Failure to collect more than 3 x 1,000,000 CD34+ stem cells/kg body weight

          7. Left ventricular ejection fraction of < 40%, unless cleared by cardiology

          8. Corrected DLCO of < 50%

          9. Patients who are on anticoagulants or antiplatelet agents.