Actively Recruiting
Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies
Led by National Cancer Institute (NCI) · Updated on 2026-04-28
320
Participants Needed
2
Research Sites
292 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a confirmed blood cancer with a standard need for allogeneic hematopoietic cell transplantation
- Age 60 to 85 years, or age 18 to 60 years and unfit for myeloablative conditioning
- At least one suitable HLA-matched related, haploidentical, matched unrelated, or \u22655/10 mismatched unrelated donor
- Karnofsky performance score of 60 or higher
- Adequate organ function including cardiac ejection fraction \u226535%, lung function \u226540% predicted, creatinine clearance \u226545 ml/min, bilirubin \u22642 times upper limit, and liver enzymes \u22645 times upper limit
- Women of child-bearing potential and men must agree to use contraception before and for at least one year after transplant
- Willing and able to provide informed consent
- Related donors aged 12 or older and unrelated donors aged 18 or older who are eligible and willing to donate research samples
You will not qualify if you...
- Receiving any other investigational agents or experimental therapies within 2 weeks before conditioning
- Poorly controlled blood cancer such as leukemia with more than 5% bone marrow blasts or active disease, or lymphoma without at least partial response
- Uncontrolled serious illness making transplantation unsafe
- Currently breastfeeding
- Active non-blood cancers that are metastatic, relapsed, refractory, or locally advanced and not curable, except nonmelanoma skin cancers
- Karnofsky performance score below 60 or less than 80 if unfit for myeloablative conditioning
- Significant organ dysfunction that makes myeloablative conditioning unsafe
- Significant life-threatening toxicities from prior chemotherapy
- Refusal of myeloablative conditioning or insistence on fertility preservation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
2
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
A
Amy H Chai
CONTACT
C
Christopher G Kanakry, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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