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NCT03128034 · ClinicalTrials.gov registry record · Phase 1
211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia
A Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, sponsored by Fred Hutchinson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT03128034: Recruiting Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, sponsored by Fred Hutchinson Cancer Center.
NCT03128034 is a Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia that is actively recruiting participants, run by Fred Hutchinson Cancer Center. The registered enrollment target is 75 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (35% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03128034, a Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by Fred Hutchinson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies the side effects and best dose of 211\^astatine(At)-BC8-B10 before donor stem cell transplant in treating patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or mixed-phenotype acute leukemia. Radioactive substances, such as astatine-211, linked to monoclonal antibodies, such as BC8, can bind to cancer cells and give off radiation which may help kill cancer cells and have less of an effect on healthy cells before donor stem cell transplant.
Primary Outcome
DLT is defined as a grade III/IV regimen-related toxicity (Bearman scale). The maximum tolerated dose will be defined as the dose of 211\^At-BC8-B10 used in combination with the reduced-intensity hematopoietic cell transplantation conditioning regimen that is associated with a grade III/IV regimen-related toxicity or true DLT rate of 25%. The data, thereby generating a dose-response curve based on the observed toxicity rate at the various dose levels visited. Based on this fitted model, the maxi
Conditions Studied
Interventions
- DRUG Mycophenolate Mofetil
- DRUG Fludarabine Phosphate
- PROCEDURE Peripheral Blood Stem Cell Transplantation
- DRUG Cyclosporine
- RADIATION Pretargeted Radioimmunotherapy
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2017-10-24 |
| Est. Completion | 2029-03-31 |
| Phase | Phase 1 |
What NCT03128034 shows while recruiting
NCT03128034 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (35% lower).
The record links to 10 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Mycophenolate Mofetil is the first listed.
NCT03128034 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT03128034 about?
NCT03128034 is a clinical study titled "211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia". This phase I/II trial studies the side effects and best dose of 211\^astatine(At)-BC8-B10 before donor stem cell transplant in treating patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or mixed-phenotype acute leukemia. Radioactive substances, s...
What is the current status of trial NCT03128034?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2017-10-24. Estimated completion is 2029-03-31.
What conditions does trial NCT03128034 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelomonocytic Leukemia, Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia.
What interventions are being tested in trial NCT03128034?
The interventions under investigation include: Mycophenolate Mofetil (DRUG), Fludarabine Phosphate (DRUG), Peripheral Blood Stem Cell Transplantation (PROCEDURE), Cyclosporine (DRUG), Pretargeted Radioimmunotherapy (RADIATION).
Who is sponsoring clinical trial NCT03128034?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03128034 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03128034's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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