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

Completed · 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, plus the addition of Rituximab (which is a form of immunotherapy).

Key facts

Study ID

NCT00143871

Run by

University of Michigan Rogel Cancer Center

People needed

35

Starts

2001-04-01

Expected to finish

2007-01-01

Last updated by the study team

2012-02-01

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.
• In relapse after primary conventional chemotherapy
• Tumor sensitive (at least a partial response) to induction chemotherapy and/ or radiation therapy after treatment for relapse
• Treatment of CNS or meningeal disease (cytology-negative CSF) if present
• Treatment of CNS or meningeal disease (cytology-negative CSF) if present.
• Cumulative total doxorubicin dosage <500 mg/m2
• Performance score: 0-2
• Prior malignancies eligible if treated for cure and without active disease
• Patients must not be pregnant or nursing.
• Prior Immunotherapy is allowed
• Signed Informed Consent
• Absolute neutrophil count > 1500/ µl, platelet count >100,000/ µl
• Bilirubin <1.5 x normal, SGOT <2.5 x normal
• Serum creatinine <1.5 mg/dl
• Ejection fraction > 45% or > 40% with normal wall motion
• HIV negative
• FEV1, DLCO > 50% predicted

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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