NCT00048412

Stem Cell Transplant for Patients With Blood Malignancy Using Donors and Less Toxic Chemotherapy With CAMPATH 1H

Phase I/II Study of Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancy, Using MHC Identical or Near Identical Donors and Sub-Myeloablative Conditioning With CAMPATH 1H (DIMSUM)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (planned)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

1. To assess the treatment related mortality of allogeneic stem cell transplantation with non-myeloablative therapy incorporating the lymphodepleting MAb CAMPATH-1H, in patients with hematological diseases and renal cell carcinoma not eligible for conventional (myeloablative) therapy. 2. To assess the time to engraftment and incidence of graft failure in patients receiving this transplant regimen. 3. To assess the safety, pharmacokinetics and immunologic activity of CAMPATH-1H when used as part of a subablative conditioning regimen.

Detailed description

This is a two arm study in which outcomes will be assessed independently in recipients of HLA matched sibling transplants and recipients of unrelated or mismatched family donor transplants, although both groups will receive identical treatments. The following will be given to the patient after admission: Day - 6: Total body irradiation Day - 5 to - 2: Fludarabine and Campath 1H Day - 1: Day of rest Day 0: Stem cell transplant (infusion)

Conditions

• Myelodysplastic Disorders
• Leukemia
• Multiple Myeloma
• Plasma Cell Dyscrasia
• Lymphoproliferative Disorders

Interventions

Type	Name	Description
DRUG	FLUDARABINE
DRUG	CAMPATH 1H
DRUG	FK50
PROCEDURE	Stem Cell Collection and Infusion

Timeline

• Start date: 2000-06-01
• Primary completion: 2004-11-12
• Completion: 2004-11-12
• First posted: 2002-11-01
• Last updated: 2020-01-18

Locations

2 sites across 1 country: United States