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NCT03670966 · ClinicalTrials.gov registry record · Phase 1
211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome
A Phase 1 study of Chronic Myelomonocytic Leukemia and Refractory Acute Myeloid Leukemia, sponsored by Fred Hutchinson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03670966: Recruiting Phase 1 study of Chronic Myelomonocytic Leukemia and Refractory Acute Myeloid Leukemia, sponsored by Fred Hutchinson Cancer Center.
NCT03670966 is a Phase 1 study of Chronic Myelomonocytic Leukemia and Refractory Acute Myeloid Leukemia that is actively recruiting participants, run by Fred Hutchinson Cancer Center. The registered enrollment target is 30 participants, below the 88-participant average among 73 other Chronic Myelomonocytic Leukemia trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03670966, a Phase 1 study of Chronic Myelomonocytic Leukemia and Refractory Acute Myeloid Leukemia, is actively recruiting participants, sponsored by Fred Hutchinson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies the side effects and best dose of a radioactive agent linked to an antibody (211At-BC8-B10) followed by donor stem cell transplant in treating patients with high-risk acute leukemia or myelodysplastic syndrome that has come back (recurrent) or isn't responding to treatment (refractory). 211At-BC8-B10 is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy and total body irradiation before a 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. Sometimes the transplanted cells from a donor can attack the body's normal cells, called graft versus host disease. Giving cyclophosphamide, mycophenolate mofetil, and tacrolimus after a transplant may stop this from happening.
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 Cyclophosphamide
- BIOLOGICAL Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10
- RADIATION Total-Body Irradiation
- PROCEDURE Peripheral Blood Stem Cell Transplantation
- PROCEDURE Bone Marrow Transplantation
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-07-10 |
| Est. Completion | 2029-03-20 |
| Phase | Phase 1 |
What NCT03670966 shows while recruiting
NCT03670966 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 88-participant average among 73 other Chronic Myelomonocytic Leukemia trials with a reported enrollment target (66% lower).
The record links to 10 conditions, with Chronic Myelomonocytic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03670966 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT03670966 about?
NCT03670966 is a clinical study titled "211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome". This phase I/II trial studies the side effects and best dose of a radioactive agent linked to an antibody (211At-BC8-B10) followed by donor stem cell transplant in treating patients with high-risk acute leukemia or myelodysplastic syndrome that has come back (recurrent) or isn't responding to treatm...
What is the current status of trial NCT03670966?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2019-07-10. Estimated completion is 2029-03-20.
What conditions does trial NCT03670966 study?
This clinical trial studies the following conditions: Chronic Myelomonocytic Leukemia, Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Refractory Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT03670966?
The interventions under investigation include: Cyclophosphamide (DRUG), Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10 (BIOLOGICAL), Total-Body Irradiation (RADIATION), Peripheral Blood Stem Cell Transplantation (PROCEDURE), Bone Marrow Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT03670966?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03670966 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Myelomonocytic 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 NCT03670966's enrollment target sits among peer trials
30 54th of 73 higher than 19 of 73 other Chronic Myelomonocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Myelomonocytic 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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