NCT04375631View on ClinicalTrials.gov

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

PHASE1RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

December 3, 2020

Primary Completion Date

February 28, 2027

Study Completion Date

March 17, 2027

Conditions
Recurrent Acute Myeloid LeukemiaRecurrent Chronic Myelomonocytic LeukemiaRecurrent Myelodysplastic SyndromeRefractory Acute Myeloid LeukemiaRefractory Chronic Myelomonocytic LeukemiaRefractory Mixed Phenotype Acute LeukemiaRefractory Myelodysplastic SyndromeRefractory Acute Leukemia of Ambiguous LineageRefractory Acute Undifferentiated Leukemia
Interventions
DRUG

Cladribine

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Cyclosporine

Given IV then PO

DRUG

Cytarabine

Given IV

BIOLOGICAL

Filgrastim

Given SC

PROCEDURE

Hematopoietic Cell Transplantation

Undergo HCT

DRUG

Mitoxantrone

Given IV

DRUG

Mycophenolate Mofetil

Given IV or PO

DRUG

Mycophenolate Sodium

Given PO

RADIATION

Total-Body Irradiation

Undergo TBI

DRUG

Idarubicin

Given IV

DRUG

Fludarabine

Given IV

DRUG

Cytarabine

Given IV

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

PROCEDURE

Echocardiography Test

Undergo ECHO

PROCEDURE

X-Ray Imaging

Undergo x-ray

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy and aspirate

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow biopsy and aspirate

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Trial Locations (1)

98109

RECRUITING

Fred Hutch/University of Washington Cancer Consortium, Seattle

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Fred Hutchinson Cancer Center

OTHER