Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma
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).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Dose-Intensive Chemotherapy Combined With Monoclonal Antibody Therapy and Targeted Radioimmunotherapy for Untreated Patients With High-Risk B-Cell Non-Hodgkin's Lymphoma|
- 1 Year Progression-free Survival Rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]Progression-free survival is measured from the first day of induction chemotherapy to the date of progression, relapse or death.
- Disease-free Survival in Patients With a Complete Response (CR or CRu) [ Time Frame: 10 years ] [ Designated as safety issue: No ]Disease-free survival is measured from the date of CR or CRu to date of relapse or death
- Overall Survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]Overall Survival is measured from the first day of chemotherapy until death from any cause.
- Overall Response [ Time Frame: During the treatment period ] [ Designated as safety issue: No ]Number of patients who achieved a complete response (CR or CRu) or partial response as defined by Cheson criteria,at any time during the treatment period.
- Secondary Malignancies [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]The number of patients who develop a secondary malignancies including solid tumors, acute leukemia and myelodysplasia or other bone marrow failure syndromes.
|Study Start Date:||June 2005|
|Estimated Study Completion Date:||February 2021|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Experimental: All subjects
Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy:Bexxar
1.5g/m2 IV over 1 hour on days 1-4 of induction for a total dose of 6.0g/m2
Other Name: Cytoxan®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.
Other Name: VP-16Drug: rituximab
375mg/m2 each week x 4 weeks of induction, beginning on day 1
Other Name: RituxanDrug: cytarabine
3g/m2 IV over 1 hour every 12 during consolidation for a total of 8 doses
Other Name: Ara-CDrug: doxorubicin
45mg/m2/day IV over 30 minutes on days 1, 2, 3 during consolidation
Other Name: AdriamycinDrug: 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.
Other Name: Bexxar
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
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||David Rizzieri, MD||Duke Unversity Medical Center|