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NCT01200329 · ClinicalTrials.gov registry record · Phase 2
High-Dose Gemcitabine, Busulfan and Melphalan for Patients With Refactory Hodgkin's Disease
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
NCT01200329: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01200329 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 81 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01200329, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if the combination of gemcitabine, busulfan, and melphalan, when given before a stem cell transplant, can help to control refractory Hodgkin's disease. The safety of this study treatment will also be studied.
Primary Outcome
The event-free survival (EFS) of patients with poor prognosis relapse or refractory Hodgkin's disease (HD) after high-dose chemotherapy (HDC) with Gemcitabine/Busulfan/Melphalan (GemBuMel). Event is defined as relapse, tumor progression or death.Progression free survival is the length of time during and after the treatment of disease that a patient lives with the disease but it does not get worse. Toxicity is defined as the treatment related mortality (TRM) rate, which will be evaluated within 3
Interventions
- DRUG Melphalan
- DRUG Busulfan
- DRUG Gemcitabine
- DRUG Palifermin
- PROCEDURE Stem Cell Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2011-06 |
| Est. Completion | 2018-12-06 |
| Phase | Phase 2 |
What the finished NCT01200329 record still lists
NCT01200329 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower).
The record links to 0 conditions, and to 5 interventions - of which Melphalan is the first listed.
NCT01200329 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01200329 about?
NCT01200329 is a clinical study titled "High-Dose Gemcitabine, Busulfan and Melphalan for Patients With Refactory Hodgkin's Disease". The goal of this clinical research study is to learn if the combination of gemcitabine, busulfan, and melphalan, when given before a stem cell transplant, can help to control refractory Hodgkin's disease. The safety of this study treatment will also be studied.
What is the current status of trial NCT01200329?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2011-06. Estimated completion is 2018-12-06.
What interventions are being tested in trial NCT01200329?
The interventions under investigation include: Melphalan (DRUG), Busulfan (DRUG), Gemcitabine (DRUG), Palifermin (DRUG), Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT01200329?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01200329's enrollment target sits among peer trials
81 834th of 2000 higher than 1,159 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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