Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Molecular Risk Assessment in Planning Treatment for Patients With Non-Hodgkin's Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Genetics, Treatment	Closed	18 and over	NCI	CWRU-060244 CWRU-1402, NCT00055640

Objectives

1. Determine whether molecular risk assessment can identify groups of patients with diffuse large B-cell non-Hodgkin's lymphoma (NHL) who will demonstrate at least 50% difference in early response rates to treatment as determined by positron-emission tomography (PET) imaging.
2. Determine, by PET imaging, the response rate of patients treated with cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab.
3. Determine whether early response rates can be predicted by gene expression profiles at diagnosis in these patients.
4. Compare gene expression profiles of patients with refractory or relapsed large cell NHL with profiles of the disease at diagnosis.
5. Determine relapse-free and overall survival rates of these patients.
6. Determine the feasibility of a new NHL treatment algorithm based on prognostic index and molecular risk, and early response assessment by PET imaging.

Entry Criteria

Disease Characteristics:

• Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma



• CD20 and/or CD19 positive by immunohistochemistry or flow cytometry



• Disease evaluable by positron-emission tomography scan



• Diagnostic tissue (either frozen or fresh unfixed) available for molecular testing or willing to undergo a repeat procedure to obtain such tissue



• No CNS involvement by lymphoma

Prior/Concurrent Therapy:

Biologic therapy

• No prior immunotherapy
• No prior biological response modifier therapy

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy
• No prior radioimmunotherapy

Surgery

• Not specified

Patient Characteristics:

Age

• 18 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin no greater than 3 mg/dL

Renal

• Creatinine no greater than 3 mg/dL

Cardiovascular

• LVEF at least 40%

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No significant organ dysfunction that would preclude study chemotherapy
• HIV negative

Expected Enrollment

A total of 36-50 patients will be accrued for this study.

Outline

Molecular risk assessment is performed using lymph node tissue from initial diagnosis to test for "activated" genes before starting treatment.

Patients receive rituximab IV over 3-6 hours, cyclophosphamide IV over 30 minutes, doxorubicin IV over 5 minutes, and vincristine IV over 5 minutes on day 1 and oral prednisone on days 1-5. Treatment repeats every 21 days for 3-8 courses. Patients undergo whole-body positron-emission tomography (PET) scanning at baseline and after course 3 to determine response. Results from the genetic testing and PET scans are used to determine further treatment recommendations.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

Trial Contact Information

Trial Lead Organizations

Ireland Cancer Center at University Hospitals/Case Medical Center

Omer Koc, MD, Protocol chair(Contact information may not be current)		Ph: 216-844-8797

Registry Information
Official Title		Molecular Risk Guided Treatment Of Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Trial Start Date		2002-10-24
Registered in ClinicalTrials.gov		NCT00055640
Date Submitted to PDQ		2002-12-23
Information Last Verified		2005-05-20
NCI Grant/Contract Number		CA43703

Back to Top