The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation

Recruiting Phase 1 Phase 2 Interventional Study
Peripheral Blood Stem Cell Transplantation Hematopoietic Stem Cell Transplantation
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
12 – 120
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
260 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
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About This Trial
Background: Blood cancers (such as leukemias or lymphomas) often do not respond to standard treatments. A transplant of blood stem cells from a healthy donor can help people with these cancers. Sometimes these transplants cause serious side effects, including a common immunologic problem called graft-versus-host disease. A drug called cyclophosphamide given early after the transplant (post-transp…
Trial Locations
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Eligibility Criteria
* INCLUSION CRITERIA: Recipient * Participants must have a histologically or cytologically confirmed hematologic malignancy with standard indication for allogeneic hematopoietic cell transplantation limited to one of the following: * Acute myeloid leukemia (AML) of intermediate or adverse risk …
Contacts

Amy H Chai

(240) 858-3755

amy.chai@nih.gov

CONTACT

Christopher G Kanakry, M.D.

(240) 760-6171

christopher.kanakry@nih.gov

CONTACT