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

NCT00625729 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2017-12-28

Study results available
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Summary

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.

Conditions

  • Leukemia
  • Lymphoma

Interventions

BIOLOGICAL

aldesleukin

Day 0-14, 10 million international units, 3 times per week for 6 doses

BIOLOGICAL

allogeneic natural killer cells

Day 0 infusion of cells (1.5-8 x 10\^7 cells/kg).

BIOLOGICAL

rituximab

Administered Day -8, day -1, day +6 and day +13, intravenously (IV) 357 mg/m\^2

DRUG

cyclophosphamide

60 mg/kg intravenous (IV) on Day -5.

DRUG

fludarabine phosphate

Day -6 through day -2, 25 mg/m\^2 intravenous (IV)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Veronika Bachanova, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-12-31
Completion
2010-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00625729 on ClinicalTrials.gov