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

NCT00383994 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2019-07-31

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

GM-CSF

250 micrograms subcutaneously 3 times a week for 4 weeks starting a day before the administration of Rituximab.

DRUG

Rituximab

375 mg/m\^2 by vein followed by 1000 mg/m\^2 weekly for 3 weeks for a total of 4 doses.

BIOLOGICAL

NK Cell Infusion

NK cells will be infused one week after the fourth dose of Rituximab and GM-CSF.

Sponsors & Collaborators

  • Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Issa F. Khouri, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2019-07-22
Completion
2019-07-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00383994 on ClinicalTrials.gov