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NCT04262843 · ClinicalTrials.gov registry record · Phase 2
Total Marrow and Lymphoid Irradiation as Conditioning Regimen Before Hematopoietic Cell Transplantation in Patients With Myelodysplastic Syndrome or Acute Leukemia
A Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT04262843 is a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 33 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04262843, a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well total marrow and lymphoid irradiation works as a conditioning regimen before hematopoietic cell transplantation in patients with myelodysplastic syndrome or acute leukemia. Total body irradiation can lower the relapse rate but has some fatal side effects such as irreversible damage to normal internal organs and graft-versus-host disease (a complication after transplantation in which donor's immune cells recognize the host as foreign and attack the recipient's tissues). Total body irradiation is a form of radiotherapy that involves irradiating the patient's entire body in an attempt to suppress the immune system, prevent rejection of the transplanted bone marrow and/or stem cells and to wipe out any remaining cancer cells. Intensity-modulated radiation therapy (IMRT) is a more recently developed method of delivering radiation. Total marrow and lymphoid irradiation is a method of using IMRT to direct radiation to the bone marrow. Total marrow and lymphoid irradiation may allow a greater dose of radiation to be delivered to the bone marrow as a preparative regimen before hematopoietic cell transplant while causing less side effects to normal organs than standard total body irradiation.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Fludarabine Phosphate
- PROCEDURE Hematopoietic Cell Transplantation
- BIOLOGICAL Granulocyte Colony-Stimulating Factor
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2020-02-07 |
| Est. Completion | 2026-06-23 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04262843
The ClinicalTrials.gov registry entry for NCT04262843 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (72% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT04262843 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04262843 about?
NCT04262843 is a clinical study titled "Total Marrow and Lymphoid Irradiation as Conditioning Regimen Before Hematopoietic Cell Transplantation in Patients With Myelodysplastic Syndrome or Acute Leukemia". This phase II trial studies how well total marrow and lymphoid irradiation works as a conditioning regimen before hematopoietic cell transplantation in patients with myelodysplastic syndrome or acute leukemia. Total body irradiation can lower the relapse rate but has some fatal side effects such as ...
What is the current status of trial NCT04262843?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2020-02-07. Estimated completion is 2026-06-23.
What conditions does trial NCT04262843 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, High Risk Myelodysplastic Syndrome.
What interventions are being tested in trial NCT04262843?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Fludarabine Phosphate (DRUG), Hematopoietic Cell Transplantation (PROCEDURE), Granulocyte Colony-Stimulating Factor (BIOLOGICAL).
Who is sponsoring clinical trial NCT04262843?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04262843 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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