Expired Study
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Durham, North Carolina 27710


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).


Study summary:

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


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.


Study is Available At:


Original ID:

Pro00007096


NCT ID:

NCT00577629


Secondary ID:

GSK-103421


Study Acronym:


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


Overall Status:

Active, not recruiting


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Duke University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, In


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

39


Enrollment Type:

Actual


Overall Contact Information

Official Name:David Rizzieri, MD
Principal Investigator
Duke Unversity Medical Center

Study Dates

Start Date:June 2005
Completion Date:February 2021
Completion Type:Anticipated
Primary Completion Date:February 2012
Primary Completion Type:Actual
Verification Date:June 2016
Last Changed Date:June 20, 2016
First Received Date:December 18, 2007
First Results Date:March 4, 2013

Study Outcomes

Outcome Type:Primary Outcome
Measure:1 Year Progression-free Survival Rate
Time Frame:1 year
Safety Issues:False
Description: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 th
Outcome Type:Secondary Outcome
Measure:Disease-free Survival in Patients With a Complete Response (CR or CRu)
Time Frame:10 years
Safety Issues:False
Description:Disease-free survival is measured from the date of CR or CRu to date of relapse or death
Outcome Type:Secondary Outcome
Measure:Overall Survival
Time Frame:10 years
Safety Issues:False
Description:Overall Survival is measured from the first day of chemotherapy until death from any cause.
Outcome Type:Secondary Outcome
Measure:Overall Response
Time Frame:up to 1 year
Safety Issues:False
Description: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. PR
Outcome Type:Secondary Outcome
Measure:Secondary Malignancies
Time Frame:10 years
Safety Issues:True
Description:The number of patients who develop a secondary malignancies including solid tumors, acute leukemia and myelodysplasia or other bone marrow failure syndromes.

Study Interventions

Intervention Type:Drug
Name:cyclophosphamide
Description:1.5g/m2 IV over 1 hour on days 1-4 of induction for a total dose of 6.0g/m2
Arm Name:Induction + Consolidation + Bexxar
Other Name:Cytoxan®
Intervention Type:Drug
Name:etoposide
Description:300mg/m2 IV over 1 hour every 12 on days 1-3 of induction for a total dose of 1.8 g/m2.
Arm Name:Induction + Consolidation + Bexxar
Other Name:VP-16
Intervention Type:Drug
Name:rituximab
Description:375mg/m2 each week x 4 weeks of induction, beginning on day 1
Arm Name:Induction + Consolidation + Bexxar
Other Name:Rituxan
Intervention Type:Drug
Name:cytarabine
Description:3g/m2 IV over 1 hour every 12 during consolidation for a total of 8 doses
Arm Name:Induction + Consolidation + Bexxar
Other Name:Ara-C
Intervention Type:Drug
Name:doxorubicin
Description:45mg/m2/day IV over 30 minutes on days 1, 2, 3 during consolidation
Arm Name:Induction + Consolidation + Bexxar
Other Name:Adriamycin
Intervention Type:Drug
Name:tositumomab
Description: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.
Arm Name:Induction + Consolidation + Bexxar
Other Name:Bexxar

Study Arms

Study Arm Type:Experimental
Arm Name:Induction + Consolidation + Bexxar
Description:Induction:Cyclophosphamide, Etoposide, and Rituxan (rituximab) followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar (tositumomab)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Duke University
Agency Class:Industry
Agency Type:Collaborator
Agency Name:GlaxoSmithKline

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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