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NCT03734601 · ClinicalTrials.gov registry record · Phase 2
Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation
A Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Stanford University.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT03734601: Completed Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Stanford University.
NCT03734601 is a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes that has completed, run by Stanford University. The registered enrollment target is 22 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03734601, a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate whether addition of a low dose of total body irradiation (TBI) to a standard preparation for transplant \[total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG)\] conditioning will help to augment donor chimerism without reducing tolerability of this regimen or increasing the risk of graft-vs-host disease (GVHD)
Primary Outcome
Subsequent to TLI/ATG/TBI conditioning, the proportion of participants with full dose donor chimerism (FDC) will be determined by Day 28. FDC is defined as achieving ≥ 95% donor type in the CD3+ lineage within 28 days of donor cell infusion, as assessed by short tandem repeat (STR) testing. The outcome will be expressed as the number of participants that achieve FDC by Day 28, a number without dispersion.
Conditions Studied
Interventions
- DRUG Tacrolimus
- DRUG Anti-thymocyte globulin (ATG)
- DRUG Mycophenolate mofetil (MMF)
- RADIATION Total body irradiation (TBI)
- RADIATION Total lymphoid irradiation (TLI)
Study Locations (1)
California
- Stanford University School of Medicine - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2018-11-05 |
| Est. Completion | 2020-11-17 |
| Phase | Phase 2 |
What the finished NCT03734601 record still lists
NCT03734601 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (81% lower).
The record links to 9 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Tacrolimus is the first listed.
NCT03734601 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03734601 about?
NCT03734601 is a clinical study titled "Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation". The purpose of this study is to evaluate whether addition of a low dose of total body irradiation (TBI) to a standard preparation for transplant \[total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG)\] conditioning will help to augment donor chimerism without reducing tolerability of t...
What is the current status of trial NCT03734601?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2018-11-05. Estimated completion is 2020-11-17.
What conditions does trial NCT03734601 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes, Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma, Chronic Myelomonocytic Leukemia.
What interventions are being tested in trial NCT03734601?
The interventions under investigation include: Tacrolimus (DRUG), Anti-thymocyte globulin (ATG) (DRUG), Mycophenolate mofetil (MMF) (DRUG), Total body irradiation (TBI) (RADIATION), Total lymphoid irradiation (TLI) (RADIATION).
Who is sponsoring clinical trial NCT03734601?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03734601 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03734601's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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