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Recruiting Phase 1 NCT04375631

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

Trial Parameters

Condition Recurrent Acute Myeloid Leukemia
Sponsor Fred Hutchinson Cancer Center
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 120
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2020-12-03
Completion 2027-02-28
Interventions
CladribineCyclophosphamideCyclosporine

Brief 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 Criteria

Inclusion Criteria: * Age \>= 18 years with an Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) =\< 5 for patients over 60 years -(Enrollment of patients \>= 75 years of age will require case presentation at the transplant Patient Care Conference (PCC) and approval by consensus) * Acute myeloid leukemia (AML) (2016 World Health Organization \[WHO\] criteria) that is either primary refractory (as defined by failure of 2 cycles of 7+3-like chemotherapy, 1 cycle of high-dose cytarabine-based chemotherapy, or at least 2 cycles of venetoclax in combination with other therapies), or is in untreated or unsuccessfully treated first or subsequent relapse. Patients in morphological remission (i.e. \< 5% blasts in the bone marrow) but evidence of minimal residual disease (MRD) by multiparameter flow cytometry, cytogenetics/fluorescence in situ hybridization (FISH), or molecular means will be eligible for trial participation. Patients with relapsed or refractory acute leukemia of ambi

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