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

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.

Conditions

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Filippo Milano · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-03

Primary Completion

2027-02-28

Completion

2027-03-17

FDA Drug

Yes

Countries

• United States

Study Locations