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

NCT ID: NCT00577629

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-18
• Study Completion Date: 2016-11-03

Brief Summary

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).

Detailed 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

Conditions

Lymphoma, B-Cell

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Induction + Consolidation + Bexxar

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

Group Type: EXPERIMENTAL

cyclophosphamide

Intervention Type: DRUG

1.5g/m2 IV over 1 hour on days 1-4 of induction for a total dose of 6.0g/m2

etoposide

Intervention Type: DRUG

300mg/m2 IV over 1 hour every 12 on days 1-3 of induction for a total dose of 1.8 g/m2.

rituximab

Intervention Type: DRUG

375mg/m2 each week x 4 weeks of induction, beginning on day 1

cytarabine

Intervention Type: DRUG

3g/m2 IV over 1 hour every 12 during consolidation for a total of 8 doses

doxorubicin

Intervention Type: DRUG

45mg/m2/day IV over 30 minutes on days 1, 2, 3 during consolidation

tositumomab

Intervention Type: DRUG

450mg unlabeled tositumomab over 1 hour, followed by 5 millicurie (mCi) Iodine I-131 labeled tositumomab over 20 minutes on day 0. Therapeutic dose of labeled tositumomab will be administered on day 15.

Interventions

cyclophosphamide

1.5g/m2 IV over 1 hour on days 1-4 of induction for a total dose of 6.0g/m2

Intervention Type: DRUG

etoposide

300mg/m2 IV over 1 hour every 12 on days 1-3 of induction for a total dose of 1.8 g/m2.

Intervention Type: DRUG

rituximab

375mg/m2 each week x 4 weeks of induction, beginning on day 1

Intervention Type: DRUG

cytarabine

3g/m2 IV over 1 hour every 12 during consolidation for a total of 8 doses

Intervention Type: DRUG

doxorubicin

45mg/m2/day IV over 30 minutes on days 1, 2, 3 during consolidation

Intervention Type: DRUG

tositumomab

450mg unlabeled tositumomab over 1 hour, followed by 5 millicurie (mCi) Iodine I-131 labeled tositumomab over 20 minutes on day 0. Therapeutic dose of labeled tositumomab will be administered on day 15.

Intervention Type: DRUG

Other Intervention Names

Cytoxan®; VP-16; Rituxan; Ara-C; Adriamycin; Bexxar

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Rizzieri, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Unversity Medical Center

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

GSK-103421

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

5762

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00007096

Identifier Type: -

Identifier Source: org_study_id