MDACC Study Summary 2004-0271

Study Summary
No. 2004-0271:.......Lymphoma......Chitra M. Hosing......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	2004-0271

Study Title:	Randomized trial using standard dose versus high dose rituximab in addition to autologous transplantation with BEAM for patients with Diffuse Large B cell lymphomas.

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 II	Return Visit:	Every 3 months till 6 months after transplantation, then every 6 months for 3 years

Treatment Agents:	Carmustine Cytarabine Etoposide Melphalan Rituximab	Home Care:	Patients may receive intravenous fluids, intravenous antibiotics and injections of growth factors at home

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Hospital stay approximately 3 weeks. Houston stay 6 weeks

Description/
Intervention:

The goal of this clinical research study is to learn if giving high dose
rituximab with transplantation and high dose chemotherapy is more effective
than giving standard dose rituximab with transplantation and high dose
chemotherapy in the treatment of non-Hodgkin's lymphoma. The safety of these
two treatments will be compared. The safety of giving autologous
transplantation in patients with non-Hodgkin's lymphoma who are older than 65
years of age will also be studied.

Study Objectives / Outcomes

Cohort 1. Patients who are less than or equal to 65 years of age.
To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose rituximab)

Cohort 2. Patients who are older than 65 years of age
1. To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose rituximab)
2. To determine the treatment related mortality (TRM)

Study Status Information



Study Activation / Registration Date:	03/03/2005

IRB Review and Approval Date:	10/20/2004

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	100

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 histologically proven diffuse large B-cell (CD20 positive) or transformed follicular non-Hodgkin's lymphomas, that have relapsed after conventional chemotherapy and are not eligible for protocols of higher priority

2) Patients must have chemosensitive disease to salvage chemotherapy and less than 5% bone marrow involvement with lymphoma by gross pathologic examination

3) Age less than or equal to 80 years. There is no lower age limit for this study.

4) Zubrod performance status of less than 2

5) Negative pregnancy test in patients with child bearing potential

6) Must be willing to sign informed consent

7) Should be seronegative for HIV, hepatitis B surface antigen, hepatitis C antibody.

Exclusion Criteria:

1) Patients with known active CNS disease are excluded. Patients with prior history of CNS disease should have a negative MRI of the brain (and/or spine if indicated) and negative CSF cytology within 4 weeks of enrollment into the study.

2) Less than 3 weeks from last cytotoxic chemotherapy

3) Serum bilirubin > 1.5 mg/dl

4) Serum transaminases > 2X/ULN

5) Serum creatinine > 1.6 mg/dl

6) Failure to collect more than 3 x 1,000,000 CD34+ stem cells/kg body weight

7) Left ventricular ejection fraction of < 40%, unless cleared by cardiology

8) Corrected DLCO of < 50%

9) Patients who are on anticoagulants or antiplatelet agents.

Links

Registration Number: NCT00472056
Study Information on Clinical Trials Registry (clinicaltrials.gov)