Return to List

Study Summary
No. 2005-0234:.......Leukemia; Lymphoma......Issa F. Khouri......Stem Cell Transplantation and Cellular Therapy
.
Study Summary Title
Study Summary
Number:		2005-0234
Study Title:Immunotherapy with NK cell, Rituximab and rhu-GMCSF in Non-myeloablative Allogeneic Stem Cell Transplantation
.
Physician New Patient Referral
Name:Issa F. KhouriPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Stem Cell Transplantation and Cellular TherapyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-8750
Contact us about clinical trials
.
General Information
Disease Group:Leukemia
Lymphoma		Supported By:N/A
Phase of Study:N/AReturn
Visit:		5 times during the first year and then annually.
Treatment
Agents:		GM-CSF
Rituximab		Home Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		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.
.
Study Objectives / Outcomes
1.0 To determine the safety of Natural Killer (NK) cells and Rituximab + rhu-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.
.
Study Status Information
Study Activation / Registration Date:09/27/2006
IRB Review and Approval Date:12/07/2005
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Terminated
Projected Accrual:N/A
.
Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
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
.
Links
Registration Number: NCT00383994
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
.
Results

Return to Clinical Trials at M.D. Anderson Cancer Center