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NCT04959175 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies
A Phase 1 study of Hematologic Neoplasms, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 320
- Enrollment target
- 2
- Study locations
NCT04959175 is a Phase 1 study of Hematologic Neoplasms that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 320 participants, below the 1,010-participant average among 20 other Hematologic Neoplasms trials with a reported enrollment target (68% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT04959175, a Phase 1 study of Hematologic Neoplasms, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 320 participants
- Enrollment target
- 2
- Study locations
Study Summary
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 Studied
Interventions
- DRUG Fludarabine
- DRUG Sirolimus
- DRUG Mycophenolate Mofetil
- DRUG Filgrastim
- PROCEDURE Allogeneic HSCT
Study Locations (2)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2021-09-23 |
| Est. Completion | 2027-04-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04959175
The ClinicalTrials.gov registry entry for NCT04959175 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,010-participant average among 20 other Hematologic Neoplasms trials with a reported enrollment target (68% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hematologic Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which Fludarabine is the first listed.
NCT04959175 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Maryland, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04959175 about?
NCT04959175 is a clinical study titled "Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies". 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 usi...
What is the current status of trial NCT04959175?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 320 participants. The study started on 2021-09-23. Estimated completion is 2027-04-30.
What conditions does trial NCT04959175 study?
This clinical trial studies the following conditions: Hematologic Neoplasms.
What interventions are being tested in trial NCT04959175?
The interventions under investigation include: Fludarabine (DRUG), Sirolimus (DRUG), Mycophenolate Mofetil (DRUG), Filgrastim (DRUG), Allogeneic HSCT (PROCEDURE).
Who is sponsoring clinical trial NCT04959175?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04959175 being conducted?
This trial has 2 study locations across Maryland, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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