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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03670966
The ClinicalTrials.gov registry entry for NCT03670966 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 88-participant average among 73 other Chronic Myelomonocytic Leukemia trials with a reported enrollment target (66% lower). The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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