Penostatin, Rituximab and Ontak and Allogeneic Natural Killer (NK) Cells for Refractory Lymphoid Malignancies

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT01181258
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    375 mg/m\^2 administered intravenously (IV) weekly \* 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)
  • Interleukin-2 — BIOLOGICAL
    subcutaneously administered 9 million international units (IU) every other day \* 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight \< 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.
  • Natural killer cells — BIOLOGICAL
    administered intravenously 1.5 to 8 \* 10\^7 cells/kg on Day 0 (day of NK cell infusion)
  • Cyclophosphamide — DRUG
    60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine.
  • Methylprednisolone — DRUG
    1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion.
  • Fludarabine — DRUG
    25 mg/m\^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through day -2).

Study Details

In this study the investigators investigate a cell therapy strategy that could harness allogeneic effectors that can potentially mediate anti-lymphoma effect. The investigators have designed a novel lymphodepleting conditioning regimen followed by infusion of donor-derived natural killer (NK) cells and interleukin-2 (IL-2) for patients with refractory lymphoid malignancies.

Key Dates

Start date
Aug 31, 2010
Status verified
Jan 2016
Primary completion
Sep 30, 2015
Completion
Jul 31, 2016

Study Design

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

Arms

  • Experimental: Patients Receiving NK Cell Infusion
    Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL

Primary Outcome Measure

Number of Patients With an Objective Response [ Time Frame: Month 2 Post Infusion ]

Locations (1)

FacilityCityStateZIPSite coordinators
Masonic Cancer Center, University of MinnesotaMinneapolisMinnesota55455-

Find similar trials in Minneapolis, MN

By condition
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By specialty
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By research site
Masonic Cancer Center, University of Minnesota· Minneapolis, MN

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