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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01203722
The ClinicalTrials.gov registry entry for NCT01203722 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 87 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.
NCT01203722 reports 0 study locations.
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.
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