Immunotherapy With NK Cell, Rituximab and Rhu-GMCSF in Non-Myeloablative Allogeneic Stem Cell Transplantation

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00383994
Phase
PHASE1
Status
Completed

Conditions

  • Disorder Related to Transplantation
  • Leukemia
  • Lymphoid Malignancies
  • Lymphoma
  • Transplantation, Stem Cell

Eligibility Criteria

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

Interventions

  • GM-CSF — DRUG
    250 micrograms subcutaneously 3 times a week for 4 weeks starting a day before the administration of Rituximab.
  • Rituximab — DRUG
    375 mg/m\^2 by vein followed by 1000 mg/m\^2 weekly for 3 weeks for a total of 4 doses.
  • NK Cell Infusion — BIOLOGICAL
    NK cells will be infused one week after the fourth dose of Rituximab and GM-CSF.

Study Details

The goal of this clinical research study is to find out if giving a boost of natural killer (NK) cells from a donor combined with Rituxan (rituximab), can help to control disease in patients who have already received an allogeneic stem cell transplant. The safety of this treatment will also be studied. Participants have recurrent chronic lymphocytic leukemia (CLL) or lymphoma after non-myeloablative stem cell transplantation. Primary Objectives: 1.0 To determine the safety of Natural Killer (NK) cells and Rituximab + rhu-Granulocyte-macrophage colony-stimulating factor (GMCSF) in patients with persistent or recurrent B-cell lymphoid malignancies after non-myeloablative stem cell transplantation. 2.0 To determine factors associated with response.

Key Dates

Start date
Sep 30, 2006
Status verified
Jul 2019
Primary completion
Jul 22, 2019
Completion
Jul 22, 2019

Study Design

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

Arms

  • Experimental: Immunotherapy with NK Cell, Rituximab + GM-CSF
    Immunotherapy in Non-myeloablative Allogeneic Stem Cell Transplantation GM-CSF = Granulocyte-Macrophage Colony-Stimulating Factor

Primary Outcome Measure

Dose-limiting toxicities (DLTs) for NK cells infusions after non-myeloablative transplantation for lymphoid malignancies [ Time Frame: Evaluated for toxicity within 6 weeks of treatment ]

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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