Leukemia Study
COG# ASCT0431: A Randomized Trial of Siorolimus-Based Graft Versus Host Disease Prophylaxys after Hematopoietic Stem Cell Transplatation in Selected Patients with CR1 and CR2 ALL
Protocol ID
Protocol Description
This is a phase III study of the drug sirolimus (rapamycin). A phase III study is done to compare the effects, good and/or bad, of an experimental treatment against a standard treatment. Sirolimus has been approved by the Food and Drug Administration (FDA) and has been used clinically for more than 10 years. Sirolimus belongs to a group of medicines known as immunosuppressive agents (drugs used to prevent the rejection of transplanted organs and tissue). It is used to lower the body's natural immunity in patients who receive transplants.
The goals of this study are:
- To compare the effects, good and/or bad, of an experimental treatment against a standard treatment plan given to patients following stem cell transplant.
- To compare the chance of relapse, transplant-related complications, and graft-versus-host disease (GVHD) in patients receiving experimental treatment with those receiving standard treatment.
In addition to the treatment goals, we would like to use specimens collected on this study to answer some research questions that might benefit future patients.
Eligibility Criteria
Patients who have been treated for acute lymphoblastic leukemia (ALL) whose leukemia has either come back (relapsed) after initial therapy and is of intermediate or high risk or whose leukemia is at a very high risk of relapsing for the first time.
Primary Investigator(s)
- Indira Sahdev, MD