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. Definitions of response criteria are as described by Cheson. Progressive Disease: >50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for PDs or nonresponders, appearance of any new lesion during or at the end of therapy.
- 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: up to 1 year ] [ Designated as safety issue: No ]
Number of subjects who achieved a complete response (CR) or partial response (PR) any time during the treatment period.
CR = complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.
- >/= 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.
- No increase should be observed in the size of other nodes, liver, or spleen.
- Splenic and hepatic nodules must regress by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter.
- Except splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.
- Patients who achieve a CR by the above criteria, but who have persistent morphologic bone marrow involvement will be considered partial responders.
- No new sites of disease should be observed.
- 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: Induction + Consolidation + Bexxar
Induction:Cyclophosphamide, Etoposide, and Rituxan (rituximab) followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar (tositumomab)
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577629
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||David Rizzieri, MD||Duke Unversity Medical Center|