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NCT01707004 · ClinicalTrials.gov registry record · Phase 2
Decitabine and Total-Body Irradiation Followed By Donor Bone Marrow Transplant and Cyclophosphamide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
A Phase 2 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT01707004: Completed Phase 2 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), sponsored by University of Wisconsin, Madison.
NCT01707004 is a Phase 2 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 20 participants, below the 118-participant average among 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01707004, a Phase 2 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well decitabine and total-body irradiation followed by donor bone marrow transplant and cyclophosphamide works in treating patients with relapsed or refractory acute myeloid leukemia. Giving decitabine and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells. It may also 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 decitabine and total-body irradiation before the transplant together with high-dose cyclophosphamide, tacrolimus, and mycophenolate mofetil after the transplant may stop this from happening.
Primary Outcome
Will be analyzed using Kaplan-Meier (KM) method, and OS will be obtained from the KM estimates along with 95% confidence intervals.
Conditions Studied
Interventions
- DRUG cyclophosphamide
- DRUG fludarabine phosphate
- DRUG tacrolimus
- DRUG decitabine
- DRUG busulfan
Study Locations (1)
Wisconsin
- University of Wisconsin Hospital and Clinics - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-05-16 |
| Est. Completion | 2017-10-07 |
| Phase | Phase 2 |
What the finished NCT01707004 record still lists
NCT01707004 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 118-participant average among 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials with a reported enrollment target (83% lower).
The record links to 10 conditions, with Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities appearing as the primary indexed condition, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT01707004 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT01707004 about?
NCT01707004 is a clinical study titled "Decitabine and Total-Body Irradiation Followed By Donor Bone Marrow Transplant and Cyclophosphamide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia". This phase II trial studies how well decitabine and total-body irradiation followed by donor bone marrow transplant and cyclophosphamide works in treating patients with relapsed or refractory acute myeloid leukemia. Giving decitabine and total-body irradiation before a donor bone marrow transplant h...
What is the current status of trial NCT01707004?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2013-05-16. Estimated completion is 2017-10-07.
What conditions does trial NCT01707004 study?
This clinical trial studies the following conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22).
What interventions are being tested in trial NCT01707004?
The interventions under investigation include: cyclophosphamide (DRUG), fludarabine phosphate (DRUG), tacrolimus (DRUG), decitabine (DRUG), busulfan (DRUG).
Who is sponsoring clinical trial NCT01707004?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01707004 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
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 NCT01707004's enrollment target sits among peer trials
20 24th of 29 higher than 5 of 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities 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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