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

Phase 1

Completed

• Conditions: Myelodysplastic Disorders; Leukemia; Multiple Myeloma; Plasma Cell Dyscrasia; Lymphoproliferative Disorders

• Registration Number: NCT00048412
• Lead Sponsor: Baylor College of Medicine

Brief 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)

Study Timeline

• Study Start: 2000-06
• Study First Submitted: 2002-10-30
• Study First Submitted QC: 2002-10-31
• Study First Posted: 2002-11-01
• Primary Completion: 2004-11-12
• Study Completion: 2004-11-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-15
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (2)

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

The Methodist Hospital; 🇺🇸 Houston, Texas, United States