Study of Rituximab Plus High-Dose Chemotherapy Poor Prognosis Non-Hodgkin's Lymphoma

Stopped early · Phase 2

Conditions studied: Lymphoma, Non-Hodgkin's

In brief

This study is being conducted to determine the safety, side effects, and response to a combination of an established high-dose chemotherapy regimen, stem cell support and Rituximab (which is a form of immunotherapy).

Key facts

Study ID

NCT00141700

Run by

University of Michigan Rogel Cancer Center

People needed

30

Starts

2003-03-01

Expected to finish

2005-12-01

Last updated by the study team

2008-01-10

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically documented, aggressive and/or intermediate grade and high-grade B cell NHL, CD20 positive.
• Histologic subtypes include follicular large cell, diffuse small cleaved cell, diffuse mixed small and large cell, diffuse large cell, anaplastic large cell, and mantle cell lymphomas.
• NHL must have high-intermediate or high International Prognostic Index (standard IPI) score at diagnosis. Mantle cell NHL is eligible regardless of IPI score.
• Complete or partial response to first-line therapy.
• Treated CNS or meningeal disease, using radiation therapy and/or intrathecal chemotherapy, is allowed. Patients with meningeal disease must have cytologically negative CSF at time of study entry.
• Cumulative total doxorubicin: <500 mg/m2
• Performance score 0-2
• Patients with a prior malignancy are eligible if they were treated with curative intent and have no evidence of active disease.
• Patients must not be pregnant or nursing.
• Informed Consent

You may not qualify if…

• pregnant or nursing

Where it is running

• The University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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