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Anti-Human CD45 Monoclonal Antibodies in Patients With Advanced Leukemia Prior to Allogeneic Stem Cell Transplantation — ADVL  

LEUKEMIA Clinical Trial

Official title:
Phase I Study of Anti-Human CD45 Monoclonal Antibodies in Patients With Advanced Leukemia Prior to Allogeneic Stem Cell Transplantation (ADVL)

Clinical Trial Summary

Participants in this study have a hematologic malignancy which is a disorder in the bone marrow that affects the body's ability to create blood. Participants might benefit from receiving an allogeneic stem cell transplant (meaning the cells come from a donor). The participants donor is a family member. Stem cells are cells in the bone marrow and blood that can form a whole new blood system.

Clinical Trial Description

Patients are given high doses of chemotherapy before receiving a stem cell transplant to keep their immune system from rejecting the donor stem cells and to kill any diseased cells that remain in the body. To try and improve on the results of transplants that use high dose chemotherapy alone, we are adding an agent called anti-CD45 to the treatment prior to the stem cell transplant. Anti-CD45 is an antibody that specifically finds and destroys leukemia cells.

Patients will receive the anti-CD45 with high dose chemotherapy (including Ara-C and Cyclophosphamide) and radiotherapy. Patients will also receive Mesna which is a drug that helps prevent bladder damage which can be caused by the cyclophosphamide. High dose radiotherapy is also known as Total Body Irradiation or TBI.

Patients will receive the anti-CD45, high dose chemotherapy, and high dose radiotherapy before the stem cell transplant. We expect participation in this study will last 2 years.

A summary of the treatment follows:

- Day - 7: Ara-C, Cyclophosphamide, Mesna

- Day - 6: Ara-C, Cyclophosphamide, Mesna

- Day - 5: Ara-C, Anti-CD45

- Day - 4: Anti-CD45, TBI

- Day - 3: Anti-CD45, TBI

- Day - 2: Anti-CD45, TBI

- Day - 1: TBI

- Day 0: Stem Cell Infusion (transplant) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00057005
Study type Interventional
Source Baylor College of Medicine
Contact
Status Completed
Phase Phase 1
Start date February 2003
Completion date October 2009
View Details
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