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NCT01244906 · ClinicalTrials.gov registry record · Phase 2
Post-transplant Cyclophosphamide and Sirolimus Following Reduced Intensity Conditioning (RIC) Transplant
A Phase 2 study of Hematologic Neoplasms, sponsored by Northside Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT01244906: Completed Phase 2 study of Hematologic Neoplasms, sponsored by Northside Hospital.
NCT01244906 is a Phase 2 study of Hematologic Neoplasms that has completed, run by Northside Hospital. The registered enrollment target is 26 participants, below the 1,025-participant average among 20 other Hematologic Neoplasms trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01244906, a Phase 2 study of Hematologic Neoplasms, has completed, sponsored by Northside Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
This trial will evaluate the safety and efficacy of post-transplant Cy and sirolimus following reduced intensity allogeneic SCT. It is hoped that the combination of a reduced intensity preparative regimen with a calcineurin-free GVHD prophylaxis regimen will decrease the risk of acute and chronic GVHD, by both limiting mucosal toxicity and augmenting immune reconstitution, thereby improving the safety of the procedure. The past experience with post-transplant Cy suggests that SCT recipients will attain rapid donor T cell chimerism, which the investigators hope will translate into improved disease control through the well documented graft-versus-malignancy effects of donor T cells.
Primary Outcome
To estimate the incidence of graft-versus-host disease (GVHD) when utilizing post-transplant cyclophosphamide (Cy) and sirolimus for GVHD prophylaxis following reduced intensity allogeneic hematopoietic stem cell transplantation (SCT) in patients with high risk hematologic malignancies.
Conditions Studied
Interventions
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
Study Locations (1)
Georgia
- Northside Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2010-12 |
| Est. Completion | 2014-12 |
| Phase | Phase 2 |
What the finished NCT01244906 record still lists
NCT01244906 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 1,025-participant average among 20 other Hematologic Neoplasms trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Hematologic Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which Allogeneic Hematopoietic Stem Cell Transplantation is the first listed.
NCT01244906 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT01244906 about?
NCT01244906 is a clinical study titled "Post-transplant Cyclophosphamide and Sirolimus Following Reduced Intensity Conditioning (RIC) Transplant". This trial will evaluate the safety and efficacy of post-transplant Cy and sirolimus following reduced intensity allogeneic SCT. It is hoped that the combination of a reduced intensity preparative regimen with a calcineurin-free GVHD prophylaxis regimen will decrease the risk of acute and chronic GV...
What is the current status of trial NCT01244906?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2010-12. Estimated completion is 2014-12.
What conditions does trial NCT01244906 study?
This clinical trial studies the following conditions: Hematologic Neoplasms.
What interventions are being tested in trial NCT01244906?
The interventions under investigation include: Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT01244906?
This trial is sponsored by Northside Hospital, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01244906 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01244906's enrollment target sits among peer trials
26 17th of 20 higher than 3 of 20 other Hematologic Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hematologic Neoplasms 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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