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NCT01629511 · ClinicalTrials.gov registry record · Phase 1
Allogeneic Stem Cell Transplant for CLL
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT01629511: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01629511 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01629511, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This phase I/II trial studies the best dose and side effects of gemcitabine and how well it works with clofarabine and busulfan and donor stem cell transplant in treating participants with chronic lymphocytic leukemia. Drugs used in chemotherapy, such as gemcitabine, clofarabine, and busulfan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer 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. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.
Primary Outcome
Number of deaths related to treatment by day 100 post allogeneic transplant
Interventions
- DRUG Busulfan
- BIOLOGICAL Anti-Thymocyte Globulin
- BIOLOGICAL Filgrastim
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
- DRUG Clofarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2012-11-21 |
| Est. Completion | 2018-04-25 |
| Phase | Phase 1 |
Why NCT01629511 stopped before completion
NCT01629511 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 5 interventions - of which Busulfan is the first listed.
NCT01629511 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01629511 about?
NCT01629511 is a clinical study titled "Allogeneic Stem Cell Transplant for CLL". This phase I/II trial studies the best dose and side effects of gemcitabine and how well it works with clofarabine and busulfan and donor stem cell transplant in treating participants with chronic lymphocytic leukemia. Drugs used in chemotherapy, such as gemcitabine, clofarabine, and busulfan, work ...
What is the current status of trial NCT01629511?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2012-11-21. Estimated completion is 2018-04-25.
What interventions are being tested in trial NCT01629511?
The interventions under investigation include: Busulfan (DRUG), Anti-Thymocyte Globulin (BIOLOGICAL), Filgrastim (BIOLOGICAL), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), Clofarabine (DRUG).
Who is sponsoring clinical trial NCT01629511?
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 NCT01629511's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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