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NCT00410982 · ClinicalTrials.gov registry record · Phase 1
Gemcitabine Plus Busulfan, Melphalan and Hematopoietic Cell Transplant for Advanced Lymphoid Malignancies
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 145
- Enrollment target
NCT00410982: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00410982 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 145 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (142% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00410982, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 145 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest tolerated dose of gemcitabine that can be given with busulfan and melphalan. The safety of this drug combination will also be studied.
Primary Outcome
MTD defined as dose level where one of two participants enrolled at a given time have no dose limiting toxcities (DLT) at that dose level. Continual reassessment from baseline for DLT, monitored daily during hospitalization, weekly to Day 30 and monthly to Day 100. Dose level assessed with each 21-day dose escalation cycle, Gemcitabine delivered Day -8 to Day -5 of 21 day cycle.
Interventions
- DRUG Melphalan
- DRUG Busulfan
- DRUG Gemcitabine
- OTHER Hematopoietic Cell Transplantation
- DRUG Rituximab for Patients with B-Cell Malignancies
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2006-12 |
| Est. Completion | 2012-09 |
| Phase | Phase 1 |
What the finished NCT00410982 record still lists
NCT00410982 is an interventional study that assigns participants to a tested intervention. The registered 145 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 (142% higher).
The record links to 0 conditions, and to 5 interventions - of which Melphalan is the first listed.
NCT00410982 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00410982 about?
NCT00410982 is a clinical study titled "Gemcitabine Plus Busulfan, Melphalan and Hematopoietic Cell Transplant for Advanced Lymphoid Malignancies". The goal of this clinical research study is to find the highest tolerated dose of gemcitabine that can be given with busulfan and melphalan. The safety of this drug combination will also be studied.
What is the current status of trial NCT00410982?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 145 participants. The study started on 2006-12. Estimated completion is 2012-09.
What interventions are being tested in trial NCT00410982?
The interventions under investigation include: Melphalan (DRUG), Busulfan (DRUG), Gemcitabine (DRUG), Hematopoietic Cell Transplantation (OTHER), Rituximab for Patients with B-Cell Malignancies (DRUG).
Who is sponsoring clinical trial NCT00410982?
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 NCT00410982's enrollment target sits among peer trials
145 391st of 2000 higher than 1,607 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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