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NCT04375631 · ClinicalTrials.gov registry record · Phase 1
CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia
A Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, sponsored by Fred Hutchinson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT04375631 is a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia that is actively recruiting participants, run by Fred Hutchinson Cancer Center. The registered enrollment target is 120 participants, above the 45-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (167% higher). The trial reports 1 study location across 1 state.
The verdict
NCT04375631, a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, is actively recruiting participants, sponsored by Fred Hutchinson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the best dose of total body irradiation when given with cladribine, cytarabine, filgrastim, and mitoxantrone (CLAG-M) or idarubicin, fludarabine, cytarabine and filgrastim (FLAG-Ida) chemotherapy reduced-intensity conditioning regimen before stem cell transplant in treating patients with acute myeloid leukemia, myelodysplastic syndrome, or chronic myelomonocytic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Giving chemotherapy and total body irradiation before a donor peripheral blood stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When the healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets and may help destroy any remaining cancer cells. Sometimes the transplanted cells from a donor can attack the body's normal cells called graft versus host disease. Giving cyclophosphamide, cyclosporine, and mycophenolate mofetil after the transplant may stop this from happening.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Cladribine
- DRUG Cytarabine
- BIOLOGICAL Filgrastim
- DRUG Cyclosporine
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2020-12-03 |
| Est. Completion | 2027-03-17 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04375631
The ClinicalTrials.gov registry entry for NCT04375631 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 45-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (167% higher). The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
The record links to 9 conditions, with Refractory Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT04375631 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT04375631 about?
NCT04375631 is a clinical study titled "CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia". This phase I trial studies the best dose of total body irradiation when given with cladribine, cytarabine, filgrastim, and mitoxantrone (CLAG-M) or idarubicin, fludarabine, cytarabine and filgrastim (FLAG-Ida) chemotherapy reduced-intensity conditioning regimen before stem cell transplant in treatin...
What is the current status of trial NCT04375631?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2020-12-03. Estimated completion is 2027-03-17.
What conditions does trial NCT04375631 study?
This clinical trial studies the following conditions: Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Recurrent Myelodysplastic Syndrome, Refractory Myelodysplastic Syndrome, Recurrent Chronic Myelomonocytic Leukemia.
What interventions are being tested in trial NCT04375631?
The interventions under investigation include: Cyclophosphamide (DRUG), Cladribine (DRUG), Cytarabine (DRUG), Filgrastim (BIOLOGICAL), Cyclosporine (DRUG).
Who is sponsoring clinical trial NCT04375631?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04375631 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.