Autologous and Allogenic Transplantation With Campath-1H for T-Cell Lymphoma

• Status: Terminated
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Bayer
• Treatments: Alemtuzumab; Carmustine; Cyclophosphamide; Cytarabine; Etoposide; Etoposide phosphate; Fludarabine; Fludarabine phosphate; Lenograstim; Melphalan; Molgramostim; Sargramostim; Vidarabine

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.