RecruitingPhase 1NCT04375631

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

CLAG-M or FLAG-Ida Chemotherapy Followed Immediately by Related/Unrelated Reduced-Intensity Conditioning (RIC) Allogeneic Hematopoietic Cell Transplantation for Adults With Myeloid Malignancies at High Risk of Relapse: A Phase 1 Study


Sponsor

Fred Hutchinson Cancer Center

Enrollment

120 participants

Start Date

Dec 3, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests an intensive chemotherapy regimen followed by a bone marrow transplant (stem cell transplant from a donor) for people with blood cancers — specifically acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML) — that have come back or stopped responding to treatment. It compares two chemotherapy combinations (CLAG-M and FLAG-Ida) to see which works better before transplant. **You may be eligible if...** - You are 18 or older - You have AML, MDS, or CMML that has relapsed or not responded to prior treatment - You have a suitable stem cell donor available (matched related, matched unrelated, or half-matched/haploidentical) - You are in reasonable health with adequate heart, lung, liver, and kidney function - Your overall health score (Karnofsky or ECOG) indicates you can tolerate intensive treatment **You may NOT be eligible if...** - You have active cancer in the brain or spinal fluid - You have active uncontrolled infections - You are pregnant or breastfeeding - You have an illness expected to cause death within the next year unrelated to your blood cancer - You are currently receiving other anti-leukemia treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCladribine

Given IV

DRUGCyclophosphamide

Given IV

DRUGCyclosporine

Given IV then PO

DRUGCytarabine

Given IV

BIOLOGICALFilgrastim

Given SC

PROCEDUREHematopoietic Cell Transplantation

Undergo HCT

DRUGMitoxantrone

Given IV

DRUGMycophenolate Mofetil

Given IV or PO

DRUGMycophenolate Sodium

Given PO

RADIATIONTotal-Body Irradiation

Undergo TBI

DRUGIdarubicin

Given IV

DRUGFludarabine

Given IV

DRUGCytarabine

Given IV

PROCEDUREMultigated Acquisition Scan

Undergo MUGA

PROCEDUREEchocardiography Test

Undergo ECHO

PROCEDUREX-Ray Imaging

Undergo x-ray

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy and aspirate

PROCEDUREBone Marrow Aspiration

Undergo bone marrow biopsy and aspirate

PROCEDUREBiospecimen Collection

Undergo blood sample collection


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

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NCT04375631


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