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NCT00857389 · ClinicalTrials.gov registry record · Phase 2
Thiotepa-Clofarabine-Busulfan With Allogeneic Stem Cell Transplant for High Risk Malignancies
A Phase 2 study of Lymphoma and Leukemia, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT00857389: Completed Phase 2 study of Lymphoma and Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT00857389 is a Phase 2 study of Lymphoma and Leukemia that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 60 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00857389, a Phase 2 study of Lymphoma and Leukemia, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to learn if thiotepa, busulfan, and clofarabine, when given before an allogeneic (bone marrow , blood, or cord blood cells) or haploidentical (bone marrow) stem cell transplantation can help to control cancers of the bone marrow and lymph node system. The safety of this treatment will also be studied. This is an investigational study. Thiotepa and clofarabine are FDA approved and commercially available for the treatment of leukemia. Busulfan is FDA approved and commercially available for use in stem cell transplantation. The combination of thiotepa, clofarabine, and busulfan together with a stem cell transplant is investigational. Up to 60 participants will take part in this study. All will be enrolled at M. D. Anderson.
Primary Outcome
The toxicities will be monitored and scored on a daily basis following the methods of Simon R. Practical Bayesian Guideline for Phase IIB Clinical Trials. A Bayesian stopping rule will be used to stop the trial if there is a 90% chance that the true toxicity rate exceeds the target toxicity rate of 0.25.
Conditions Studied
Interventions
- DRUG Busulfan
- DRUG Thiotepa
- PROCEDURE Allogeneic Stem Cell Transplantation
- DRUG Clofarabine
- DRUG Thymoglobulin (ATG)
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2009-03-02 |
| Est. Completion | 2019-03-09 |
| Phase | Phase 2 |
What the finished NCT00857389 record still lists
NCT00857389 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (88% lower).
The record links to 3 conditions, with Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Busulfan is the first listed.
NCT00857389 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00857389 about?
NCT00857389 is a clinical study titled "Thiotepa-Clofarabine-Busulfan With Allogeneic Stem Cell Transplant for High Risk Malignancies". Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to learn if thiotepa, busulfan, and clofarabine, when given before an allogeneic (bone marrow , blood, or cord blood cells) or haploidentical (bone m...
What is the current status of trial NCT00857389?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2009-03-02. Estimated completion is 2019-03-09.
What conditions does trial NCT00857389 study?
This clinical trial studies the following conditions: Lymphoma, Leukemia, Stem Cell Transplantation.
What interventions are being tested in trial NCT00857389?
The interventions under investigation include: Busulfan (DRUG), Thiotepa (DRUG), Allogeneic Stem Cell Transplantation (PROCEDURE), Clofarabine (DRUG), Thymoglobulin (ATG) (DRUG).
Who is sponsoring clinical trial NCT00857389?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00857389 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00857389's enrollment target sits among peer trials
60 129th of 299 higher than 163 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma 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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