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NCT01342289 · ClinicalTrials.gov registry record · Phase 1
Shorter Course Tacrolimus After Nonmyeloablative, Related Donor BMT With High-dose Posttransplantation Cyclophosphamide
A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 1
- Development phase
- 127
- Enrollment target
NCT01342289: Completed Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT01342289 is a Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 127 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (112% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01342289, a Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 127 participants
- Enrollment target
Study Summary
This research is being done to learn more about nonmyeloablative bone marrow transplantation (BMT), also known as a "mini" transplant for patients with blood cancers, using bone marrow from a relative.
Primary Outcome
Percentage of participants with severe graft versus host disease (GVHD) defined as grade III-IV acute GVHD or extensive chronic GVHD. Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade I (skin involvement stages 1+ to 2+, with no liver or GI involvement), Grade II (skin i
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Mycophenolate Mofetil
- RADIATION Total body irradiation
- DRUG Tacrolimus 60
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2011-08 |
| Est. Completion | 2018-03 |
| Phase | Phase 1 |
What the finished NCT01342289 record still lists
NCT01342289 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (112% higher).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01342289 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01342289 about?
NCT01342289 is a clinical study titled "Shorter Course Tacrolimus After Nonmyeloablative, Related Donor BMT With High-dose Posttransplantation Cyclophosphamide". This research is being done to learn more about nonmyeloablative bone marrow transplantation (BMT), also known as a "mini" transplant for patients with blood cancers, using bone marrow from a relative.
What is the current status of trial NCT01342289?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 127 participants. The study started on 2011-08. Estimated completion is 2018-03.
What interventions are being tested in trial NCT01342289?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Mycophenolate Mofetil (DRUG), Total body irradiation (RADIATION), Tacrolimus 60 (DRUG).
Who is sponsoring clinical trial NCT01342289?
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 NCT01342289's enrollment target sits among peer trials
127 459th of 2000 higher than 1,540 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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