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NCT00134017 · ClinicalTrials.gov registry record · Phase 2
Combination Chemotherapy, Bone Marrow Transplant, and Post Transplant Cyclophosphamide for Hematologic Cancer
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 2
- Development phase
- 142
- Enrollment target
NCT00134017: Completed Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT00134017 is a Phase 2 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 142 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00134017, a Phase 2 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 142 participants
- Enrollment target
Study Summary
RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer and abnormal cells and helps 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclophosphamide, mycophenolate mofetil, or tacrolimus after transplant may stop this from happening. PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with tacrolimus and mycophenolate mofetil works in treating patients who are undergoing a donor bone marrow transplant for hematologic cancer.
Primary Outcome
Percentage of participants who developed grades II-IV and grades III-IV acute 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 involvement stages 1+ to 3+, liver 1+, GI tract 1+)
Interventions
- DRUG Cyclophosphamide
- DRUG Busulfan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2004-06 |
| Est. Completion | 2010-02 |
| Phase | Phase 2 |
What the finished NCT00134017 record still lists
NCT00134017 is an interventional study that assigns participants to a tested intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Cyclophosphamide is the first listed.
NCT00134017 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00134017 about?
NCT00134017 is a clinical study titled "Combination Chemotherapy, Bone Marrow Transplant, and Post Transplant Cyclophosphamide for Hematologic Cancer". RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer and abnormal cells and helps 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 ...
What is the current status of trial NCT00134017?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 142 participants. The study started on 2004-06. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00134017?
The interventions under investigation include: Cyclophosphamide (DRUG), Busulfan (DRUG).
Who is sponsoring clinical trial NCT00134017?
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 NCT00134017's enrollment target sits among peer trials
142 507th of 2000 higher than 1,491 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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