Donor Natural Killer Cell Infusion, Rituximab, Aldesleukin, and Chemotherapy in Treating Patients With Relapsed Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT00625729
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • aldesleukin — BIOLOGICAL
    Day 0-14, 10 million international units, 3 times per week for 6 doses
  • allogeneic natural killer cells — BIOLOGICAL
    Day 0 infusion of cells (1.5-8 x 10\^7 cells/kg).
  • rituximab — BIOLOGICAL
    Administered Day -8, day -1, day +6 and day +13, intravenously (IV) 357 mg/m\^2
  • cyclophosphamide — DRUG
    60 mg/kg intravenous (IV) on Day -5.
  • fludarabine phosphate — DRUG
    Day -6 through day -2, 25 mg/m\^2 intravenous (IV)

Study Details

RATIONALE: Aldesleukin may stimulate natural killer cells to kill cancer cells. Treating natural killer cells with aldesleukin in the laboratory may help the natural killer cells kill more cancer cells when they are put back in the body. Giving monoclonal antibodies, such as rituximab, and chemotherapy drugs, such as fludarabine and cyclophosphamide, before a donor natural killer cell infusion helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. PURPOSE: This phase I/II trial is studying how well giving rituximab and chemotherapy followed by a donor natural killer cell infusion that has been treated in the laboratory with aldesleukin followed by aldesleukin works in treating patients with non-Hodgkin lymphoma or chronic lymphocytic leukemia.

Key Dates

Start date
Jan 31, 2008
Status verified
Dec 2017
Primary completion
Dec 31, 2009
Completion
Apr 30, 2010

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treated Patients
    Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with donor natural killer cells infusion, rituximab, aldesleukin and chemotherapy.

Primary Outcome Measure

Number of Patients Exhibiting Natural Killer Cell Expansion [ Time Frame: Day 14 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Masonic Cancer Center, University of MinnesotaMinneapolisMinnesota55455-

Find similar trials in Minneapolis, MN

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Masonic Cancer Center, University of Minnesota· Minneapolis, MN

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