NCT00683046

T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 100 Years
• Healthy volunteers: Not accepted

Summary

Objectives: 1. To evaluate disease free survival after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies. 2. To evaluate the incidence and severity of acute and chronic GVHD after Campath 1H-based in vivo T-cell depletion, in patients with hematologic malignancies undergoing non-myelo-ablative stem cell transplantation. 3. To evaluate engraftment and chimerism after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.

Conditions

• Acute Myelogenous Leukemia
• Lymphoid Leukemia
• Chronic Myelogenous Leukemia
• Malignant Lymphoma
• Hodgkin's Disease
• Chronic Lymphocytic Leukemia
• Myeloproliferative Disorder
• Anemia, Aplastic
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Fludarabine	Fludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3,.
DRUG	Melphalan	Melphalan 140 mg/m2 IV on day -2.
DRUG	Stem cells	Stem cell infusion on day 0.
DRUG	Campath	Campath, 20 mg IV on day -7, 6, -5, -4, and -3.

Timeline

• Start date: 2001-11-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2008-05-23
• Last updated: 2016-11-22
• Results posted: 2014-03-31

Locations

1 site across 1 country: United States