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)

Baylor College of Medicine2 sites in 1 country40 target enrollmentJune 2000

ConditionsMyelodysplastic Disorders Leukemia Multiple Myeloma Plasma Cell Dyscrasia Lymphoproliferative Disorders

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Myelodysplastic Disorders
Sponsor: Baylor College of Medicine
Enrollment: 40
Locations: 2
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.
To assess the time to engraftment and incidence of graft failure in patients receiving this transplant regimen.
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)

Registry

clinicaltrials.gov

Start Date

June 2000

End Date

November 12, 2004

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel