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

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

Overview[ - collapse ][ - ]

Purpose	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).
Condition	Lymphoma, B-Cell
Intervention	Drug: cyclophosphamide Drug: etoposide Drug: rituximab Drug: cytarabine Drug: doxorubicin Drug: tositumomab
Phase	Phase 2
Sponsor	Duke University
Responsible Party	Duke University
ClinicalTrials.gov Identifier	NCT00577629
First Received	December 18, 2007
Last Updated	March 12, 2014
Last verified	March 2014

Tracking Information[ + expand ][ + ]

First Received Date	December 18, 2007
Last Updated Date	March 12, 2014
Start Date	June 2005
Estimated Primary Completion Date	February 2021
Current Primary Outcome Measures	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.
Current Secondary Outcome Measures	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 patients who achieved a complete response (CR or CRu) or partial response as defined by Cheson criteria,at any time during the treatment period. Definitions of response criteria are as described by Cheson. 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.

Descriptive Information[ + expand ][ + ]

Brief Title	Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma
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
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
Study Type	Interventional
Study Phase	Phase 2
Study Design	Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Lymphoma, B-Cell
Intervention	Drug: cyclophosphamide 1.5g/m2 IV over 1 hour on days 1-4 of induction for a total dose of 6.0g/m2 Other Names: 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 Names: VP-16Drug: rituximab 375mg/m2 each week x 4 weeks of induction, beginning on day 1 Other Names: RituxanDrug: cytarabine 3g/m2 IV over 1 hour every 12 during consolidation for a total of 8 doses Other Names: Ara-CDrug: doxorubicin 45mg/m2/day IV over 30 minutes on days 1, 2, 3 during consolidation Other Names: 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 Names: Bexxar
Study Arm (s)	Experimental: Induction + Consolidation + Bexxar Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy:Bexxar

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
Estimated Enrollment	39
Estimated Completion Date	February 2021
Estimated Primary Completion Date	February 2012
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.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00577629
Other Study ID Numbers	Pro00007096
Has Data Monitoring Committee	No
Information Provided By	Duke University
Study Sponsor	Duke University
Collaborators	GlaxoSmithKline
Investigators	Principal Investigator: David Rizzieri, MD Duke Unversity Medical Center
Verification Date	March 2014

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