OncoMatch/Clinical Trials/NCT05436418
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
Is NCT05436418 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for peripheral blood stem cell transplantation.
Treatment: Melphalan · Sirolimus · Cyclophosphamide · Mycophenolate Mofeti · Fludarabine · Mesna · Filgrastim — 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-transplantation cyclophosphamide, PTCy) can reduce these complications. But sometimes this drug has its own negative effects. Furthermore, studies in mice suggest that an intermediate, rather than very high, dose of this drug may best protect against graft-versus-host disease. Objective: To find out if a lower dose of PTCy is more helpful for people who undergo blood stem cell transplants. Eligibility: People aged 18 and older who have a blood cancer and are eligible for a transplant of blood stem cells from another person. Healthy donors are also needed but must be related to the individual needing the transplant. Design: Participants will undergo screening. Transplant recipients will have imaging scans and tests of their heart and lung function. They will be assessed for the status of their cancer, including bone marrow taken from their pelvis and possibly also scans and/or fluid drawn from the spine depending on the disease type. Donors will be screened for general health. They will give several tubes of blood. They will give an oral swab and saliva and stool samples for research. Recipients will be in the hospital at least 4 to 6 weeks. They will have a temporary catheter inserted into a vein in the chest or neck. Medications will be given and blood will be drawn through the catheter. The transplanted stem cells will be given through the catheter. Participants will receive medications both before and after the transplant. Participants will return to the clinic at least once a week for 3 months after leaving the hospital. Follow-up visits will continue periodically for 5 years.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Allowed: TP53 17p deletion
Chronic lymphocytic leukemia with 17p deletion and/or unmutated IgHV or refractory to or intolerant of both BTK and PI3K inhibitors
Prior therapy
Must have received: tyrosine kinase inhibitor
Chronic myelogenous leukemia resistant to or intolerant of >= 3 tyrosine kinase inhibitors
Must have received: BTK inhibitor
Chronic lymphocytic leukemia...refractory to or intolerant of both BTK and PI3K inhibitors
Must have received: PI3K inhibitor
Chronic lymphocytic leukemia...refractory to or intolerant of both BTK and PI3K inhibitors
Must have received: proteasome inhibitor
Multiple myeloma, stage III, relapsing after therapy with both a proteasome inhibitor and an immunomodulatory drug (IMiD)
Must have received: immunomodulatory drug
Multiple myeloma, stage III, relapsing after therapy with both a proteasome inhibitor and an immunomodulatory drug (IMiD)
Cannot have received: investigational agent
Exception: Prior experimental therapies must have been completed at least 2 weeks prior to the date of beginning conditioning.
Participants who are receiving any other investigational agents. Prior experimental therapies must have been completed at least 2 weeks prior to the date of beginning conditioning.
Lab requirements
Kidney function
Estimated serum creatinine clearance >= 60 ml/min/1.73m^2 calculated using eGFR
Liver function
Total bilirubin <= 2X ULN; ALT and AST <= 3X ULN
Cardiac function
Ejection fraction >= 45% by 2D ECHO
Adequate organ function defined as possessing all of the following: Cardiac ejection fraction >= 45% by 2D ECHO; FEV-1, FVC, and DLCO (corrected for hemoglobin) all >= 50% predicted; Estimated serum creatinine clearance of >= 60 ml/minute/1.73m^2 calculated using eGFR in the clinical lab; Total bilirubin <= 2X the upper limit of normal; Alanine aminotransferase and aspartate aminotransferase <= 3X the upper limit of normal.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope · Duarte, California
- National Institutes of Health Clinical Center · Bethesda, Maryland
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