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

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	Intervention	Phase
Lymphoma, B-Cell	Drug: cyclophosphamide Drug: etoposide Drug: rituximab Drug: cytarabine Drug: doxorubicin Drug: tositumomab	Phase 2

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Cyclophosphamide Cytarabine Doxorubicin Doxorubicin hydrochloride Etoposide Etoposide phosphate Rituximab Tositumomab

U.S. FDA Resources

Further study details as provided by Duke University:

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.

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: 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.

Enrollment:	39
Study Start Date:	June 2005
Estimated Study Completion Date:	February 2021
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: All subjects Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy:Bexxar	Drug: cyclophosphamide 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-16 Drug: rituximab 375mg/m2 each week x 4 weeks of induction, beginning on day 1 Other Name: Rituxan Drug: cytarabine 3g/m2 IV over 1 hour every 12 during consolidation for a total of 8 doses Other Name: Ara-C Drug: doxorubicin 45mg/m2/day IV over 30 minutes on days 1, 2, 3 during consolidation Other Name: Adriamycin 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. Other Name: Bexxar

Arms

Assigned Interventions

Experimental: All subjects

Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy:Bexxar

Drug: cyclophosphamide

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-16

Drug: rituximab

375mg/m2 each week x 4 weeks of induction, beginning on day 1

Other Name: Rituxan

Drug: cytarabine

3g/m2 IV over 1 hour every 12 during consolidation for a total of 8 doses

Other Name: Ara-C

Drug: doxorubicin

45mg/m2/day IV over 30 minutes on days 1, 2, 3 during consolidation

Other Name: Adriamycin

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.

Other Name: Bexxar

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577629

Locations

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

GlaxoSmithKline

Investigators

Principal Investigator:

David Rizzieri, MD

Duke Unversity Medical Center

More Information

Additional Information:

Duke Hematologic Malignancy Program This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT00577629 History of Changes
Other Study ID Numbers:	Pro00007096, GSK-103421, 5762
Study First Received:	December 18, 2007
Results First Received:	March 4, 2013
Last Updated:	March 4, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

high risk non-hodgkins lymphoma
NHL
Bexxar
high dose chemotherapy

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Cyclophosphamide
Cytarabine
Rituximab
Etoposide phosphate
Iodine-131 anti-B1 antibody

Doxorubicin
Etoposide
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on May 23, 2013