Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma
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|ClinicalTrials.gov Identifier: NCT00577629|
Recruitment Status : Completed
First Posted : December 20, 2007
Results First Posted : April 15, 2013
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, B-Cell||Drug: cyclophosphamide Drug: etoposide Drug: rituximab Drug: cytarabine Drug: doxorubicin Drug: tositumomab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 18, 2005|
|Actual Primary Completion Date :||April 8, 2012|
|Actual Study Completion Date :||November 3, 2016|
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®
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-16
375mg/m2 each week x 4 weeks of induction, beginning on day 1
Other Name: Rituxan
3g/m2 IV over 1 hour every 12 during consolidation for a total of 8 doses
Other Name: Ara-C
45mg/m2/day IV over 30 minutes on days 1, 2, 3 during consolidation
Other Name: Adriamycin
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
- 1 Year Progression-free Survival Rate [ Time Frame: 1 year ]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 [ Time Frame: 10 years ]Disease-free survival is measured from the date of CR or CRu to date of relapse or death
- Overall Survival [ Time Frame: 10 years ]Overall Survival is measured from the first day of chemotherapy until death from any cause.
- Overall Response [ Time Frame: up to 1 year ]
Percent 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 ]The number of patients who develop secondary malignancies including solid tumors, acute leukemia and myelodysplasia or other bone marrow failure syndromes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00577629
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||David Rizzieri, MD||Duke Unversity Medical Center|