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NCT03032783 · ClinicalTrials.gov registry record · Phase 2
A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies-Increasing GVT Effects Without Increasing Toxicity
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
NCT03032783: Completed Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
NCT03032783 is a Phase 2 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 51 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03032783, a Phase 2 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
Study Summary
This phase II trial studies the how well donor stem cell transplant works in treating patients with high risk hematologic malignancies. Giving total-body irradiation and chemotherapy 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. It may also stop the patient's immune system from rejecting the donor's stem 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. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.
Primary Outcome
Will be tested using an exact one-sided binomial test with alpha 0.05. The trial will be considered successful if the null hypothesis of 45% 2-year OS is rejected. In addition, the exact binomial 95% confidence interval for 2-year OS will be computed.
Interventions
- DRUG Cyclophosphamide
- RADIATION Total-Body Irradiation
- DRUG Mycophenolate Mofetil
- DRUG Tacrolimus
- PROCEDURE Donor Lymphocyte Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2017-01-31 |
| Est. Completion | 2025-12-02 |
| Phase | Phase 2 |
What the finished NCT03032783 record still lists
NCT03032783 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03032783 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03032783 about?
NCT03032783 is a clinical study titled "A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies-Increasing GVT Effects Without Increasing Toxicity". This phase II trial studies the how well donor stem cell transplant works in treating patients with high risk hematologic malignancies. Giving total-body irradiation and chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming...
What is the current status of trial NCT03032783?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2017-01-31. Estimated completion is 2025-12-02.
What interventions are being tested in trial NCT03032783?
The interventions under investigation include: Cyclophosphamide (DRUG), Total-Body Irradiation (RADIATION), Mycophenolate Mofetil (DRUG), Tacrolimus (DRUG), Donor Lymphocyte Infusion (PROCEDURE).
Who is sponsoring clinical trial NCT03032783?
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 NCT03032783's enrollment target sits among peer trials
51 1190th of 2000 higher than 806 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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