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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02280525
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Lenalidomide — DRUG
    2.5 mg by mouth daily on Day -2 to Day +14.
  • Rituximab — DRUG
    375 mg/m2 by vein on Day -5 for participants with B-cell cancer.
  • Fludarabine — DRUG
    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
  • Cyclophosphamide — DRUG
    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.
  • NK Cells — PROCEDURE
    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.
  • Cytarabine — DRUG
    Cytarabine 2 mg/m2 by vein on Days -6 to -2.

Study Details

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.

Key Dates

Start date
Mar 5, 2015
Status verified
Jun 2023
Primary completion
Jul 9, 2019
Completion
Jul 9, 2019

Study Design

Enrollment
8 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lymphodepleting Chemotherapy Option #1
    Preferred regimen for CLL and low grade lymphoma Lenalidomide 2.5 mg by mouth once a day on Days -2 through Day +14. Fludarabine 25 mg/m2 by vein over 1 hour on Days -5 to -3. Cyclophosphamide 200 mg/m2 by vein over 3 hours on Days -5 to -3. Rituximab 375 mg/m2 by vein over 3-6 hours on Day -5 for participants with B-cell cancer. Dose Escalation Phase Starting Dose Level of NK Cells: 1 x 10\^7 NK cells/kg given by vein on Day 0. Dose Expansion Phase Starting Dose level of NK cells: Maximum tolerated dose from Dose Escalation Phase.
  • Experimental: Lymphodepleting Chemotherapy Option #2
    For all malignancies if able to tolerate higher dose cyclophosphamide per the discretion of the treating physician Lenalidomide 2.5 mg by mouth once a day on Days -2 through Day +14. Fludarabine 25 mg/m2 by vein over 1 hour on Day -6 to -2. Cyclophosphamide 60 mg/kg by vein over 3 hours on Days -5 and -4. Dose Escalation Phase Starting Dose Level of NK Cells: 1 x 10\^7 NK cells/kg given by vein on Day 0. Dose Expansion Phase Starting Dose level of NK cells: Maximum tolerated dose from Dose Escalation Phase.
  • Experimental: Lymphodepleting Chemotherapy Option #3
    For myeloid malignancies Lenalidomide 2.5 mg by mouth once a day on Days -2 to Day +14. Fludarabine 30 mg/m2 by vein over 1 hour on Days -6 to -2. Cytarabine 2 mg/m2 by vein on Days -6 to -2. Dose Escalation Phase Starting Dose Level of NK Cells: 1 x 10\^7 NK cells/kg given by vein on Day 0. Dose Expansion Phase Starting Dose level of NK cells: Maximum tolerated dose from Dose Escalation Phase.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Natural Killer (NK) Cells with Lenalidomide and Lymphodepleting Chemotherapy [ Time Frame: 30 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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