NK Cells in Cord Blood Transplantation

Summary

This phase I trial studies the side effects and best way to give natural killer cells and donor umbilical cord blood transplant in treating patients with hematological malignancies. Giving chemotherapy with or without total body irradiation before a donor umbilical cord blood 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 Biphenotypic Leukemia
• Acute Lymphoblastic Leukemia in Remission
• Acute Myeloid Leukemia in Remission
• Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• DS Stage II Plasma Cell Myeloma
• DS Stage III Plasma Cell Myeloma
• High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
• ISS Stage II Plasma Cell Myeloma
• ISS Stage III Plasma Cell Myeloma
• Myelodysplastic Syndrome
• Recurrent Acute Lymphoblastic Leukemia
• Recurrent Acute Myeloid Leukemia
• Recurrent Chronic Lymphocytic Leukemia
• Recurrent Hodgkin Lymphoma
• Recurrent Non-Hodgkin Lymphoma
• Recurrent Small Lymphocytic Lymphoma
• Refractory Acute Lymphoblastic Leukemia
• Refractory Chronic Lymphocytic Leukemia
• Refractory Hodgkin Lymphoma
• Refractory Non-Hodgkin Lymphoma
• Refractory Small Lymphocytic Lymphoma
• Secondary Acute Myeloid Leukemia
• Therapy-Related Acute Myeloid Leukemia
• Therapy-Related Myelodysplastic Syndrome

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic umbilical cord blood transplant

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine Phosphate

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Lenalidomide

Given PO

DRUG

Melphalan

Given IV

DRUG

Mycophenolate Mofetil

Given IV or PO

BIOLOGICAL

Natural Killer Cell Therapy

Given IV

BIOLOGICAL

Rituximab

Given IV

DRUG

Tacrolimus

Given IV or PO

RADIATION

Total-Body Irradiation

Undergo TBI

PROCEDURE

Umbilical Cord Blood Transplantation

Undergo allogeneic umbilical cord blood transplant

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Chitra Hosing · M.D. Anderson Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-05-03

Primary Completion

2021-11-30

Completion

2021-11-30

FDA Drug

Yes

Countries

• United States

Study Locations