NCT00577629

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

Dose-Intensive Chemotherapy Combined With Monoclonal Antibody Therapy and Targeted Radioimmunotherapy for Untreated Patients With High-Risk B-Cell Non-Hodgkin's Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	cyclophosphamide	1.5g/m2 IV over 1 hour on days 1-4 of induction for a total dose of 6.0g/m2
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.
DRUG	rituximab	375mg/m2 each week x 4 weeks of induction, beginning on day 1
DRUG	cytarabine	3g/m2 IV over 1 hour every 12 during consolidation for a total of 8 doses
DRUG	doxorubicin	45mg/m2/day IV over 30 minutes on days 1, 2, 3 during consolidation
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.

Timeline

• Start date: 2005-06-18
• Primary completion: 2012-04-08
• Completion: 2016-11-03
• First posted: 2007-12-20
• Last updated: 2017-05-30
• Results posted: 2013-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study