OncoMatch/Clinical Trials/NCT04959175
Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies
Is NCT04959175 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for hematologic neoplasms.
Treatment: Mycophenolate Mofetil · Fludarabine · Sirolimus · Filgrastim · Cyclophosphamide · Mesna — Background: Certain blood cancers can be treated with blood or bone marrow transplants. Sometimes the donor cells attack the recipient's body, called graft-versus-host disease (GVHD). The chemotherapy drug cyclophosphamide helps reduce the risk and severity of GVHD. Researchers want to learn if using a lower dose of cyclophosphamide may reduce the drug's side effects while maintaining its effectiveness. Such an approach is being used in an ongoing clinical study at the NIH with promising results, but this approach has not been tested for transplants using lower doses of chemotherapy/radiation prior to the transplant. Objective: To learn if using a lower dose of cyclophosphamide will help people have a successful transplant and have fewer problems and side effects. Eligibility: Adults ages 18-85 who have a blood cancer that did not respond well to standard treatments or is at high risk for relapse without transplant, and their donors. Design: Participants may be screened with the following: Medical history Physical exam Blood and urine tests Heart and lung tests Body imaging scans (they may get a contrast agent) Spinal tap Bone marrow biopsy Participants will be hospitalized for 4-6 weeks. They will have a central venous catheter placed in a chest or neck vein. It will be used to give medicines, transfusions, and the donor cells, and to take blood. In the week before transplant, they will get 2 chemotherapy drugs and radiation. After the transplant, they will get the study drug for 2 days. They will take other drugs for up to 2 months. Participants must stay near NIH for 3 months after discharge for weekly study visits. Then they will have visits every 3-12 months until 5 years after transplant. Participants and donors will give blood, bone marrow, saliva, cheek swab, urine, and stool samples for research.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Multiple Myeloma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Biomarker criteria
Allowed: TP53 17p deletion
Chronic lymphocytic leukemia with 17p deletion and/or unmutated IgHV
Prior therapy
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)
Must have received: BTK inhibitor
Chronic lymphocytic leukemia...refractory or intolerant of both BTK and PI3K inhibitors
Must have received: PI3K inhibitor
Chronic lymphocytic leukemia...refractory or intolerant of both BTK and PI3K inhibitors
Must have received: tyrosine kinase inhibitor
Chronic myelogenous leukemia resistant to or intolerant of >=3 tyrosine kinase inhibitors
Cannot have received: investigational agent
Exception: Prior experimental therapies must have been completed at least 2 weeks prior to the date of beginning conditioning.
Subjects 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
Serum creatinine clearance of >=45 ml/minute calculated using the Cockcroft-Gault equation
Liver function
Total bilirubin <=2X the upper limit of normal; Alanine aminotransferase and aspartate aminotransferase <=5X the upper limit of normal.
Cardiac function
Cardiac ejection fraction >=35%
Adequate organ function defined as possessing all of the following: Cardiac ejection fraction >=35%; Forced expiratory volume-1, forced vital capacity, and diffusing capacity of the lung for carbon monoxide (corrected for hemoglobin) all of >=40% predicted; Serum creatinine clearance of >=45 ml/minute calculated using the Cockcroft-Gault equation; Total bilirubin <=2X the upper limit of normal; Alanine aminotransferase and aspartate aminotransferase <=5X the upper limit of normal.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
- Hospital of the University of Pennsylvania · Philadelphia, Pennsylvania
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