Natural Killer Cells Before and After Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia

Summary

This phase I/II studies the side effects and best dose of natural killer cells before and after donor stem cell transplant and to see how well they work in treating patients with acute myeloid leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia. Giving chemotherapy with or without total body irradiation before a donor peripheral blood stem cell or bone marrow transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.

Conditions

• Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
• Acute Myeloid Leukemia With Gene Mutations
• Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• de Novo Myelodysplastic Syndrome
• Myelodysplastic Syndrome
• Recurrent Acute Myeloid Leukemia
• Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Therapy-Related Acute Myeloid Leukemia

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic PBSC or bone marrow transplant

PROCEDURE

Bone Marrow Transplantation

Undergo allogeneic PBSC or bone marrow transplant

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Melphalan

Given IV

DRUG

Mycophenolate Mofetil

Given PO

BIOLOGICAL

Natural Killer Cell Therapy

Given IV

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo allogeneic PBSC or bone marrow transplant

DRUG

Tacrolimus

Given IV and PO

RADIATION

Total-Body Irradiation

Undergo TBI

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Samer Srour · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

2 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-04-22

Primary Completion

2022-02-28

Completion

2022-02-28

FDA Drug

Yes

Countries

• United States

Study Locations