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NCT04083183 · ClinicalTrials.gov registry record · Phase 1
Total Body Irradiation and Astatine-211-Labeled BC8-B10 Monoclonal Antibody for the Treatment of Nonmalignant Diseases
A Phase 1 study of Nonmalignant Neoplasm, sponsored by Fred Hutchinson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04083183: Recruiting Phase 1 study of Nonmalignant Neoplasm, sponsored by Fred Hutchinson Cancer Center.
NCT04083183 is a Phase 1 study of Nonmalignant Neoplasm that is actively recruiting participants, run by Fred Hutchinson Cancer Center. The registered enrollment target is 40 participants, below the 5,273-participant average among 3 other Nonmalignant Neoplasm trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04083183, a Phase 1 study of Nonmalignant Neoplasm, is actively recruiting participants, sponsored by Fred Hutchinson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies the best dose of total body irradiation with astatine-211 BC8-B10 monoclonal antibody for the treatment of patients with nonmalignant diseases undergoing hematopoietic cell transplant. Radiation therapy uses high energy gamma rays to kill cancer cells and shrink tumors. Astatine-211-labeled BC8-B10 monoclonal antibody is a monoclonal antibody, called anti-CD45 monoclonal antibody BC8-B10, linked to a radioactive/toxic agent called astatine 211. Anti-CD45 monoclonal antibody BC8-B10 is attached to CD45 antigen positive cancer cells in a targeted way and delivers astatine 211 to kill them. Giving astatine-211 BC8-B10 monoclonal antibody and total-body irradiation before a donor stem cell transplant may help stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells.
Primary Outcome
Defined as establishment of \< 5% donor chimerism of CD3+ T cells and \<5% donor chimerism of CD33+ myeloid cells at day 80-100 after hematopoietic cell transplant (HCT) following an human leukocyte antigen (HLA)-matched related or unrelated graft or an unrelated graft with a single HLA-class 1 allele mismatch or DQB1 antigen or allele mismatch.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10
- BIOLOGICAL Lapine T-Lymphocyte Immune Globulin
- RADIATION Total-Body Irradiation
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-06-16 |
| Est. Completion | 2028-01-09 |
| Phase | Phase 1 |
What NCT04083183 shows while recruiting
NCT04083183 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 5,273-participant average among 3 other Nonmalignant Neoplasm trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Nonmalignant Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT04083183 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT04083183 about?
NCT04083183 is a clinical study titled "Total Body Irradiation and Astatine-211-Labeled BC8-B10 Monoclonal Antibody for the Treatment of Nonmalignant Diseases". This phase I/II trial studies the best dose of total body irradiation with astatine-211 BC8-B10 monoclonal antibody for the treatment of patients with nonmalignant diseases undergoing hematopoietic cell transplant. Radiation therapy uses high energy gamma rays to kill cancer cells and shrink tumors....
What is the current status of trial NCT04083183?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2020-06-16. Estimated completion is 2028-01-09.
What conditions does trial NCT04083183 study?
This clinical trial studies the following conditions: Nonmalignant Neoplasm.
What interventions are being tested in trial NCT04083183?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10 (BIOLOGICAL), Lapine T-Lymphocyte Immune Globulin (BIOLOGICAL), Total-Body Irradiation (RADIATION).
Who is sponsoring clinical trial NCT04083183?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04083183 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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