Donor Natural Killer Cells and Donor Stem Cell Transplant in Treating Patients With High Risk Myeloid Malignancies

Summary

This phase I/II trial studies the side effects and best dose of donor natural killer cells when given together with donor stem cell transplant and to see how well they work in treating patients with myeloid malignancies that are likely to come back or spread. Giving chemotherapy, such as busulfan and fludarabine phosphate, before a donor peripheral blood stem cell 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 Erythroid Leukemia
• Acute Megakaryoblastic Leukemia
• Acute Myeloid Leukemia
• Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
• Acute Myeloid Leukemia in Remission
• Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Blasts Under 20 Percent of Bone Marrow Nucleated Cells
• Blasts Under 20 Percent of Peripheral Blood White Cells
• Chronic Myelomonocytic Leukemia
• High Risk Myelodysplastic Syndrome
• Myelodysplastic Syndrome
• Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Therapy-Related Acute Myeloid Leukemia
• Therapy-Related Myelodysplastic Syndrome

Interventions

BIOLOGICAL

Aldesleukin

Given SC

BIOLOGICAL

Allogeneic CD56-positive CD3-negative Natural Killer Cells

Given IV

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic PBSC transplant

DRUG

Busulfan

Given IV

DRUG

Fludarabine Phosphate

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo allogeneic PBSC transplant

OTHER

Pharmacological Study

Correlative studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Richard E Champlin · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

7 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-06-11

Primary Completion

2022-05-10

Completion

2022-05-10

FDA Drug

Yes

Countries

• United States

Study Locations