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NCT01203722 · ClinicalTrials.gov registry record · Phase 1
Reduced Intensity, Partially HLA Mismatched BMT to Treat Hematologic Malignancies
A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 1
- Development phase
- 87
- Enrollment target
NCT01203722: Completed Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT01203722 is a Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 87 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01203722, a Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 87 participants
- Enrollment target
Study Summary
If transplantation using mismatched unrelated donors or non-first-degree relatives could be performed with an acceptable toxicity profile, an important unmet need would be served. Towards this goal, the current study extends our platform of nonmyeloablative, partially HLA-mismatched bone marrow transplant (BMT) and Peripheral Blood Stem Cell Transplant (PBSCT) to the use of such donors, investigating up to several postgrafting immunosuppression regimens that incorporate high-dose Cy. Of central interest is the incorporation of sirolimus into this postgrafting immunosuppression regimen. The primary goal for phase 1 is to identify a transplant regimen associated with acceptable rates of severe acute GVHD and NRM by Day 100 and for phase 2 estimate the 6-month probability of survival without having had acute grade III- IV GVHD or graft failure.
Primary Outcome
Two immunosuppressive regimens with Fludarabine-Cytoxan-TBI conditioning will be studied in reduced-intensity, partially HLA mismatched allogeneic BMT from unrelated or non-first-degree related donors. Transplant regimen will be determined by acceptable rates of severe acute GVHD (\< 25%).
Interventions
- DRUG Fludarabine
- DRUG Cytoxan
- RADIATION Total Body Irradiation
- PROCEDURE Peripheral Blood Stem Cell Transplant
- PROCEDURE Allogeneic Blood or Marrow Transplant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2010-09 |
| Est. Completion | 2024-05-28 |
| Phase | Phase 1 |
What the finished NCT01203722 record still lists
NCT01203722 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% higher).
The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.
NCT01203722 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01203722 about?
NCT01203722 is a clinical study titled "Reduced Intensity, Partially HLA Mismatched BMT to Treat Hematologic Malignancies". If transplantation using mismatched unrelated donors or non-first-degree relatives could be performed with an acceptable toxicity profile, an important unmet need would be served. Towards this goal, the current study extends our platform of nonmyeloablative, partially HLA-mismatched bone marrow tran...
What is the current status of trial NCT01203722?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 87 participants. The study started on 2010-09. Estimated completion is 2024-05-28.
What interventions are being tested in trial NCT01203722?
The interventions under investigation include: Fludarabine (DRUG), Cytoxan (DRUG), Total Body Irradiation (RADIATION), Peripheral Blood Stem Cell Transplant (PROCEDURE), Allogeneic Blood or Marrow Transplant (PROCEDURE).
Who is sponsoring clinical trial NCT01203722?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01203722's enrollment target sits among peer trials
87 651st of 2000 higher than 1,349 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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