MDACC Study Summary ID03-0239 (Archived)

Study Summary
No. ID03-0239:.......Lymphoma......Chitra M. Hosing......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	ID03-0239

Study Title:	Maintenance therapy with rituximab after autologous transplantation for non-Hodgkin's lymphoma

Physician

New Patient Referral



Name:	Chitra M. Hosing	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Stem Cell Transplantation and Cellular Therapy	Referring 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:	Lymphoma	Supported By:	N/A

Phase of Study:	Phase III	Return Visit:	Every 6 months for 3 years. Patients randomized to the rituximab arm may have to get their 1st and 3rd cycle of rituximab (all 4 doses) at M. D. Anderson if their local physician is not able to draw and ship blood samples for rituximab levels.

Treatment Agents:	Rituximab	Home Care:	None

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	None


Description/ Intervention:	The goal of this clinical research is to see if RituxanTM (rituximab) therapy given after high dose chemotherapy and transplant of a patients own stem cells will prevent or delay the return of the lymphoma.

Study Objectives / Outcomes

A randomized study evaluating the role of rituximab maintenance after autologous stem cell transplantation (ASCT) in patients with diffuse large B-cell non-Hodgkin's lymphomas (NHL). To evaluate the overall survival (OS) and progression free survival (PFS) in the two groups.

Study Status Information



Study Activation / Registration Date:	05/24/2004

IRB Review and Approval Date:	08/20/2003

Study Type:	Therapeutic

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 diffuse large B cell non-Hodgkin's lymphoma who are 5-6 months status post an autologous stem cell transplant and are in CR. Patients who are positive for t(14;18) by PCR or for BCL-2 by Southern blot are eligible provided there is no other disease present. 2) Absolute neutrophil count (ANC) > 1500/mm3 independent of growth factor support 3) No evidence of symptomatic cardiac or pulmonary disease 4) Platelet count > 75,000 mm3 5) Zubrod performance status of 2 or less. (see Appendix D) 6) Negative pregnancy test in patients of "child bearing potential"

Exclusion Criteria:

1) Uncontrolled active infection 2) Severe concomittant medical or psychiatric illness 3) Serum bilirubin > 2.0 mg/dl 4) Transaminases > 2xULN 5) Serum creatinine > 2.0 mg/dl

Links

Registration Number: NCT01103388
Study Information on Clinical Trials Registry (clinicaltrials.gov)