Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma

Duke University

Status and phase: Completed; Phase 2

Conditions: Lymphoma, B-Cell

Treatments: Drug: cytarabine; Drug: tositumomab; Drug: doxorubicin; Drug: etoposide; Drug: rituximab; Drug: cyclophosphamide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00577629

Pro00007096

GSK-103421 (Other Grant/Funding Number)

5762 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine whether using high-dose chemotherapy, monoclonal antibodies, and targeted radioimmunotherapy will slow the progression of disease in patients with high-risk Non-Hodgkin's Lymphoma (NHL).

Full description

This is a phase II efficacy trial for patients with untreated, high-risk, B-cell Non-Hodgkin's Lymphoma. The study will evaluate the efficacy and safety of high-dose chemotherapy combined with monoclonal antibodies and targeted radioimmunotherapy in previously untreated patients with high-risk NHL

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Untreated, biopsy proven B-cell non-Hodgkin's lymphoma
• Age >/= 18 years
• No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for one year. The patient cannot have been exposed to chemotherapy to treat any of these diseases for at least 3 years prior to study entry.
• Meet staging studies and laboratory tests prior to induction, consolidation and radioimmunotherapy.

Exclusion criteria

• Significant medical and/or psychiatric illness which may compromise planned treatment;
• Pregnant or lactating;
• HIV-infection.
• Patients with follicular lymphoma grade 1, 2 or 3A are not eligible for this trial.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Induction + Consolidation + Bexxar

Experimental group

Description:

Induction:Cyclophosphamide, Etoposide, and Rituxan (rituximab) followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar (tositumomab)

Treatment:

Drug: cyclophosphamide

Drug: rituximab

Drug: etoposide

Drug: tositumomab

Drug: doxorubicin

Drug: cytarabine