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NCT03712878 · ClinicalTrials.gov registry record · Phase 2
2-Step Approach to Stem Cell Transplant in Treating Participants With Hematological Malignancies
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT03712878: Completed Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
NCT03712878 is a Phase 2 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03712878, a Phase 2 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
This phase II trial studies how well a 2-step approach to stem cell transplant works in treating patients with blood cancers. Giving chemotherapy and total body irradiation before a lymphocyte (white blood cell) and stem cell transplant helps stop the growth of cells in the bone marrow including normal blood-forming cells (stem cells) and cancer cells. By giving the donor cells in two steps, the dose of lymphocytes given can be tightly controlled and they can be made more tolerant to the body. When the healthy lymphocytes and 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 tacrolimus and mycophenolate mofetil may stop this from happening.
Primary Outcome
Donor T cell chimerism (defined by 98% or greater donor T cell chimerism) by 28 days post HSCT (d+28). All estimates of rates will be presented with corresponding 95% confidence intervals. For chimerism rates, the method of Atkinson and Brown will be used to allow for the two-stage design.
Interventions
- DRUG Cyclophosphamide
- RADIATION Total-Body Irradiation
- DRUG Tacrolimus
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
- PROCEDURE Donor Lymphocyte Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-09-19 |
| Est. Completion | 2025-03-19 |
| Phase | Phase 2 |
What the finished NCT03712878 record still lists
NCT03712878 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03712878 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03712878 about?
NCT03712878 is a clinical study titled "2-Step Approach to Stem Cell Transplant in Treating Participants With Hematological Malignancies". This phase II trial studies how well a 2-step approach to stem cell transplant works in treating patients with blood cancers. Giving chemotherapy and total body irradiation before a lymphocyte (white blood cell) and stem cell transplant helps stop the growth of cells in the bone marrow including nor...
What is the current status of trial NCT03712878?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2018-09-19. Estimated completion is 2025-03-19.
What interventions are being tested in trial NCT03712878?
The interventions under investigation include: Cyclophosphamide (DRUG), Total-Body Irradiation (RADIATION), Tacrolimus (DRUG), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), Donor Lymphocyte Infusion (PROCEDURE).
Who is sponsoring clinical trial NCT03712878?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03712878's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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