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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

Q: 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.

Q: 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.

Q: What interventions are being tested in trial NCT04375631?

The interventions under investigation include: Cyclophosphamide (DRUG), Cladribine (DRUG), Cytarabine (DRUG), Filgrastim (BIOLOGICAL), Cyclosporine (DRUG).

Q: 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.

Q: 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.

A Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, sponsored by Fred Hutchinson Cancer Center.

Compiled by PlainTrial · August 8, 2026

Recruiting
Registry status: Phase 1
Development phase: 120
Enrollment target: 1
Study location

NCT04375631: Recruiting Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, sponsored by Fred Hutchinson Cancer Center.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Defined as graft rejection (\< 5% donor T-cell chimerism).

Conditions Studied

Refractory Acute Myeloid Leukemia Recurrent Acute Myeloid Leukemia Recurrent Myelodysplastic Syndrome Refractory Myelodysplastic Syndrome Recurrent Chronic Myelomonocytic Leukemia Refractory Chronic Myelomonocytic Leukemia Refractory Mixed Phenotype Acute Leukemia Refractory Acute Leukemia of Ambiguous Lineage Refractory Acute Undifferentiated Leukemia

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

Fred Hutchinson Cancer Center

483 total trials

What NCT04375631 shows while recruiting

NCT04375631 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 45-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (167% higher).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Refractory Acute Myeloid Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04375631's enrollment target sits among peer trials

120 4th of 63 higher than 59 of 63 other Refractory Acute Myeloid Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Refractory Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04375631, the US trial registry maintained by the National Library of Medicine. NCT04375631 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.