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drugset / Trial / NCT00505921

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

NCT00505921 ↗

Phase 2 Terminated 27 enrolled M.D. Anderson Cancer Center Bayer · collab
Non-randomizedSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2003-03
Primary completion
2009-11
Completion
2009-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Alemtuzumab Monoclonal antibody 15 mg Intravenous
Subject Alemtuzumab Monoclonal antibody 30 mg Intravenous
Background Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 1000 mg/m2 Intravenous
Background Cytarabine Small molecule 200 mg/m2 Intravenous
Background Etoposide Small molecule 200 mg/m2 Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous
Background G-CSF Unknown 10 mg/kg Subcutaneous
Background Melphalan Small molecule 140 mg/m2 Intravenous
Background carmustine Small molecule 300 mg/m2 Intravenous
Background sargramostim Protein / enzyme biologic 250 unknown Subcutaneous

Indications

lymphoma