Cord Blood Natural Killer (NK) Cells in Leukemia/Lymphoma

Summary

The goal of this clinical research study is to find the highest tolerable dose of immune cells called natural killer (NK) cells that can be given with chemotherapy to patients with CLL. Researchers want to learn if adding NK cells will be effective in treating the disease. The safety of this will also be studied.

NK cells may kill cancer cells that remain in your body after your last chemotherapy treatment. The NK cells will be separated from umbilical cord blood. The device used in the laboratory to separate the NK cells is called a CliniMACS. These separated NK cells will then be grown in the lab to increase the number of NK cells that can be given to you by vein.

This is an investigational study. Rituximab, fludarabine, and cyclophosphamide are FDA approved and commercially available for the treatment of CLL. Cytarabine, filgrastim, and lenalidomide are FDA approved and commercially available for the treatment of other types of cancer. The use of cytarabine, filgrastim, and lenalidomide for the treatment of CLL is investigational.

The use of NK cells is investigational. The NK cell process is not FDA approved or commercially available. It is currently being used for research purposes only.

Up to 44 patients will take part in this study. All will be enrolled at MD Anderson.

Conditions

• Leukemia

Interventions

DRUG

Lenalidomide

2.5 mg by mouth daily on Day -2 to Day +14.

DRUG

Rituximab

375 mg/m2 by vein on Day -5 for participants with B-cell cancer.

DRUG

Fludarabine

Lymphodepleting Chemotherapy Option #1: Fludarabine 25 mg/m2 by vein on Days -5 to -3. Lymphodepleting Chemotherapy Option #2: Fludarabine 25 mg/m2 by vein over 1 hour on Day -6 to -2. Lymphodepleting Chemotherapy Option #3: Fludarabine 30 mg/m2 by vein over 1 hour on Days -6 to -2

DRUG

Cyclophosphamide

Lymphodepleting Chemotherapy Option #1: Cyclophosphamide 200 mg/m2 by vein on Days -5 to -3. Lymphodepleting Chemotherapy Option #2: Cyclophosphamide 60 mg/kg by vein over 3 hours on Days -5 and -4.

PROCEDURE

NK Cells

Participant assigned to a dose level of NK cells based on when joined study. Starting dose level of NK cells 1 x 10\^7 NK cells/kg given by vein on Day 0. NK Cell Infusion Expansion Phase: Maximum tolerated dose of NK cells from Induction Phase.

DRUG

Cytarabine

Cytarabine 2 mg/m2 by vein on Days -6 to -2.

Sponsors & Collaborators

• M.D. Anderson Cancer Center

  lead OTHER

• The Leukemia and Lymphoma Society

  collaborator OTHER

• Celgene Corporation

  collaborator INDUSTRY

Principal Investigators

• Chitra M. Hosing, MD · M.D. Anderson Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-05

Primary Completion

2019-07-09

Completion

2019-07-09

FDA Drug

Yes

Countries

• United States

Study Locations