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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT04375631
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cladribine — DRUG
    Given IV
  • Cyclophosphamide — DRUG
    Given IV
  • Cyclosporine — DRUG
    Given IV then PO
  • Cytarabine — DRUG
    Given IV
  • Filgrastim — BIOLOGICAL
    Given SC
  • Hematopoietic Cell Transplantation — PROCEDURE
    Undergo HCT
  • Mitoxantrone — DRUG
    Given IV
  • Mycophenolate Mofetil — DRUG
    Given IV or PO
  • Mycophenolate Sodium — DRUG
    Given PO
  • Total-Body Irradiation — RADIATION
    Undergo TBI
  • Idarubicin — DRUG
    Given IV
  • Fludarabine — DRUG
    Given IV
  • Cytarabine — DRUG
    Given IV
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • X-Ray Imaging — PROCEDURE
    Undergo x-ray
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy and aspirate
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow biopsy and aspirate
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection

Study Details

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.

Key Dates

Start date
Dec 3, 2020
Status verified
Mar 2026
Primary completion
Feb 28, 2027
Completion
Mar 17, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (CLAG-M, TBI, HCT, GVHD prophylaxis)
    See detailed description.
  • Experimental: Arm II (FLAG-Ida, TBI, HCT, GVHD prophylaxis)
    See detailed description.

Primary Outcome Measure

Rate of hematopoietic cell transplantation (HCT) failure [ Time Frame: Within 200 days post-transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Filippo Milano
[email protected]
206-667-5925
Filippo Milano (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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