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NCT03192397 · ClinicalTrials.gov registry record · Phase 1
Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant
A Phase 1 study of Myelodysplastic Syndrome and Non-Hodgkin Lymphoma, sponsored by Roswell Park Cancer Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT03192397: Active Phase 1 study of Myelodysplastic Syndrome and Non-Hodgkin Lymphoma, sponsored by Roswell Park Cancer Institute.
NCT03192397 is a Phase 1 study of Myelodysplastic Syndrome and Non-Hodgkin Lymphoma that is active but no longer recruiting, run by Roswell Park Cancer Institute. The registered enrollment target is 35 participants, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03192397, a Phase 1 study of Myelodysplastic Syndrome and Non-Hodgkin Lymphoma, is active but no longer recruiting, sponsored by Roswell Park Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase Ib/2 trial studies how well chemotherapy, total body irradiation, and post-transplant cyclophosphamide work in reducing rates of graft versus host disease in patients with hematologic malignancies undergoing a donor stem cell transplant. Drugs used in the chemotherapy, such as fludarabine phosphate and melphalan hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft versus host disease). Giving cyclophosphamide after the transplant may stop this from happening.
Primary Outcome
Percentage of chronic GVHD of response by human leukocyte antigen (HLA) matching by cohort
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- OTHER Laboratory Biomarker Analysis
- DRUG Fludarabine Phosphate
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
- DRUG Melphalan Hydrochloride
Study Locations (1)
New York
- Roswell Park Cancer Institute - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2017-08-09 |
| Est. Completion | 2027-05-21 |
| Phase | Phase 1 |
What the registry record for NCT03192397 still lists
NCT03192397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (83% lower).
The record links to 10 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03192397 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03192397 about?
NCT03192397 is a clinical study titled "Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant". This phase Ib/2 trial studies how well chemotherapy, total body irradiation, and post-transplant cyclophosphamide work in reducing rates of graft versus host disease in patients with hematologic malignancies undergoing a donor stem cell transplant. Drugs used in the chemotherapy, such as fludarabine...
What is the current status of trial NCT03192397?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2017-08-09. Estimated completion is 2027-05-21.
What conditions does trial NCT03192397 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome, Non-Hodgkin Lymphoma, Hodgkin Lymphoma, Graft-Versus-Host Disease, Myeloproliferative Neoplasm.
What interventions are being tested in trial NCT03192397?
The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Fludarabine Phosphate (DRUG), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), Melphalan Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT03192397?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03192397 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03192397's enrollment target sits among peer trials
35 85th of 134 higher than 49 of 134 other Myelodysplastic Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndrome 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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