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

• Status: Completed
• Trial end date: 2019-07-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
• Treatments: Rituximab; Sargramostim

Criteria

Inclusion Criteria:

1. Patients with previous diagnosis of CD20+ B-cell CLL and non-Hodgkin's lymphoma who have failed standard conventional chemotherapy, and who had persistent disease at 3 months, or progressive disease after non-myeloablative allogeneic transplantation.

2. Donor willingness to donate peripheral blood (same donor of the original transplant).

3. Negative Beta HCG in a woman with child bearing potential defined as not post-menopausal for 12 months or not previous surgical sterilization.

Exclusion Criteria:

1. Pregnancy or lactation

2. HIV , HTLV-I or hepatitis.

3. Active infection(s) >/= grade 3.

4. Severe active concomitant medical or psychiatric illness.

5. Concurrent active GVHD requiring tacrolimus.