Autologous and Allogenic Transplantation With Campath-1H for T-Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Intervention: Campath-1H; G-CSF; GM-CSF; BCNU; Stem Cell Transplant; Preparative Regimen for Allogenic Stem Cell Transplantation; Cytarabine; Etoposide; Melphalan; Campath; Fludarabine; Cyclophosphamide; Low dose total body irradiation
Intervention description: 3 mg through the catheter Day 1 then 10 mg on Day 2, and 30 mg on Days 3 and 10 of chemotherapy treatment.; 10 mg/kg subcutaneously (sc) on day +5 (in a.m.) for Stem Cell Mobilization.; 250 m/m2 subcutaneously (sc) on Day +5 (in p.m.) for Stem Cell Mobilization.; 300 mg/m2 IV over 1 hour on day -6; Stem cell infusion on Day 0.; Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy on day 0.; 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses),; 200 mg/m2 IV twice on day -5 to -2 (total 8 doses); 140 mg/m2 IV on day -1.; 15 mg/day (days -6 to -4) for preparative regimen Allogenic Stem Cell Transplantation; 30 mg/m2 IV/day (days -6 to -4); 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4).; Low dose total body irradiation of 2 Gy day 0.
Intervention MeSH terms: Cytarabine; Cyclophosphamide; Melphalan; Carmustine; Fludarabine; Fludarabine phosphate; Etoposide; Etoposide phosphate; Molgramostim; Alemtuzumab; Sargramostim; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Maximum age: 70 Years
Healthy volunteers: No
Keywords: T-Cell Lymphoma; Lymphoma; Campath-1H; Allogenic Transplantation; Stem Cell Transplant; Alemtuzumab

Summary:

      Primary Objectives:

        1. To evaluate the role of autologous and allogenic stem cell transplantation with
           Campath-1H for patients with peripheral T-cell lymphoma (PTCL).

        2. To examine the impact of in-vivo purging with Campath -1H pre-autologous stem
           transplantation for patients with PTCL.

        3. To evaluate the impact of soluble CD52 upon in-vivo purging with Campath-1H.

        4. To evaluate the role of Campath -1H in the treatment minimal residual disease after
           autologous transplantation for PTCL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be less then 70 years old.

          -  Patients must have chemosensitive disease, having undergone at least partial remission
             with less then 10% marrow involvement by gross pathologic examination if autologous
             transplantation is considered.

          -  Newly diagnosed patients are eligible for autologous transplant. Patients in relapse
             would receive a non-myeloablative transplant if a sibling donor is available.
             Otherwise, patients would undergo autologous transplant if International Prognostic
             Index (IPI) is 0-1, or unrelated transplant if IPI is > 1.

        Exclusion Criteria:

          -  Criteria for exclusion are Human immunodeficiency virus (HIV) or Human T-lymphotropic
             virus (HTLV) seropositivity, pregnancy, cardiac ejection fraction by echo-cardiogram
             less than 40%, active central nervous system involvement, serum creatinine greater
             than 1.6 mg/dl or serum bilirubin greater than 1.5 mg/dl unless due to tumor, Absolute
             neutrophil count (ANC) less than 1,000/mm3 and platelets less than 100,000/mm3 unless
             due to tumor, performance status (ECOG scale) greater than 2, pulmonary function test-
             diffusing capacity of the Lung for Carbon Monoxide (DLCO) less than 40% of predicted,
             and severe concomitant medical or psychiatric illnesses.