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NCT03247088 · ClinicalTrials.gov registry record · Phase 1
Sorafenib, Busulfan and Fludarabine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia Undergoing Donor Stem Cell Transplant
A Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
- 1
- Study location
NCT03247088: Active Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT03247088 is a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 74 participants, above the 46-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (61% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03247088, a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies the best dose of sorafenib when given together with busulfan and fludarabine in treating patients with acute myeloid leukemia that has come back or does not respond to treatment and who are undergoing donor stem cell transplant. Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as busulfan and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving sorafenib with busulfan and fludarabine may work better in treating patients with recurrent or refractory acute myeloid leukemia.
Primary Outcome
Toxicity is defined as grade 3 or higher regimen-related non-hematologic, non-infectious, and non-graft versus host disease (GVHD) toxicity occurring during the period from day -5 to pre-transplant to day 30 post-transplant. Dose-finding will be done using the Bayesian Model Averaging Continual Reassessment (BMA-CRM) method.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Busulfan
- BIOLOGICAL Filgrastim
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2017-07-30 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What the registry record for NCT03247088 still lists
NCT03247088 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, above the 46-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (61% higher).
The record links to 2 conditions, with Refractory Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03247088 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03247088 about?
NCT03247088 is a clinical study titled "Sorafenib, Busulfan and Fludarabine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia Undergoing Donor Stem Cell Transplant". This phase I/II trial studies the best dose of sorafenib when given together with busulfan and fludarabine in treating patients with acute myeloid leukemia that has come back or does not respond to treatment and who are undergoing donor stem cell transplant. Sorafenib may stop the growth of cancer c...
What is the current status of trial NCT03247088?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2017-07-30. Estimated completion is 2027-12-31.
What conditions does trial NCT03247088 study?
This clinical trial studies the following conditions: Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia.
What interventions are being tested in trial NCT03247088?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Busulfan (DRUG), Filgrastim (BIOLOGICAL), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT03247088?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03247088 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
Similar trials for Refractory Acute Myeloid Leukemia
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 NCT03247088's enrollment target sits among peer trials
74 13th of 63 higher than 51 of 63 other Refractory Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Refractory Acute Myeloid Leukemia 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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