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NCT03983850 · ClinicalTrials.gov registry record · Phase 1
Optimizing PTCy Dose and Timing
A Phase 1 study of Graft-Versus-Host Disease and Hematologic Neoplasms, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 105
- Enrollment target
- 1
- Study location
NCT03983850: Active Phase 1 study of Graft-Versus-Host Disease and Hematologic Neoplasms, sponsored by National Cancer Institute (NCI).
NCT03983850 is a Phase 1 study of Graft-Versus-Host Disease and Hematologic Neoplasms that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 105 participants, above the 80-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (31% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03983850, a Phase 1 study of Graft-Versus-Host Disease and Hematologic Neoplasms, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 105 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Stem cell or bone marrow transplants can cure or control blood cancers. Sometimes the donor cells see the recipient's body as foreign. This can cause complications. A high dose of the drug cyclophosphamide (PTCy) can help reduce these risks. Researchers want to see if a lower dose of PTCy can have the same benefits. Based on encouraging results from the first part of the study, researchers now are investigating whether a lower dose of PTCy can allow other immunosuppression to be decreased. Objective: To see if a lower dose of PTCy and now also shorter duration of another immunosuppressant called mycophenolate mofetil will help people with blood cancers have a more successful transplant and fewer side effects. Eligibility: People ages 15-65 with leukemia, lymphoma, or multiple myeloma that is not curable with standard therapy and is at high risk of returning without transplant, and their healthy adult relatives Design: Transplant participants will be screened with: Blood, urine, breathing, and heart tests Scans Chest x-ray Bone marrow samples: A needle inserted into the participant s pelvis will remove marrow and a bone fragment. Transplant recipients will stay at the hospital and be prepped with chemotherapy over 6 days for the transplant. They will get stem cells through a catheter in the chest or neck. They will get the cyclophosphamide chemotherapy. They will stay in the hospital about 4 more weeks. They will have blood transfusions. They will have frequent blood tests and 2 bone marrow samples within 1 year after the transplant. Donor participants will be screened with: Blood, urine, and heart tests Chest x-ray Scans Donor participants will have bone marrow taken from their pelvis or stem cells taken from their blood. For the blood donation, blood will be taken from a vein in one arm, move through a machine to remove white blood cells, and be returned through a vein in the other arm. Participation will last up to 5 years....
Primary Outcome
The fraction of evaluable patients who experience grade III-IV aGVHD at day +60 will be determined and reported along with 80% and 95% two-sided confidence intervals. The MMF duration level patients may be compared with the PTCy dose level patients which serves as a baseline for standard duration MMF.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Sirolimus
- DRUG Busulfan
- DRUG Mycophenolate Mofetil
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2019-07-09 |
| Est. Completion | 2026-10-26 |
| Phase | Phase 1 |
What the registry record for NCT03983850 still lists
NCT03983850 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, above the 80-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (31% higher).
The record links to 2 conditions, with Graft-Versus-Host Disease appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03983850 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03983850 about?
NCT03983850 is a clinical study titled "Optimizing PTCy Dose and Timing". Background: Stem cell or bone marrow transplants can cure or control blood cancers. Sometimes the donor cells see the recipient's body as foreign. This can cause complications. A high dose of the drug cyclophosphamide (PTCy) can help reduce these risks. Researchers want to see if a lower dose of PT...
What is the current status of trial NCT03983850?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 105 participants. The study started on 2019-07-09. Estimated completion is 2026-10-26.
What conditions does trial NCT03983850 study?
This clinical trial studies the following conditions: Graft-Versus-Host Disease, Hematologic Neoplasms.
What interventions are being tested in trial NCT03983850?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Sirolimus (DRUG), Busulfan (DRUG), Mycophenolate Mofetil (DRUG).
Who is sponsoring clinical trial NCT03983850?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03983850 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03983850's enrollment target sits among peer trials
105 5th of 38 higher than 34 of 38 other Graft-Versus-Host Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Graft-Versus-Host Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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