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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by (Responsible Party):

Duke University

ClinicalTrials.gov Identifier:

NCT00577629

First received: December 18, 2007

Last updated: March 4, 2013

Last verified: March 2013

History of Changes

Results First Received: March 4, 2013

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Lymphoma, B-Cell
Interventions:	Drug: cyclophosphamide Drug: etoposide Drug: rituximab Drug: cytarabine Drug: doxorubicin Drug: tositumomab

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited between September 2005 and March 2011 at Duke University Medical Center.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

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

Participant Flow: Overall Study

	All Subjects
STARTED	39
COMPLETED	38
NOT COMPLETED	1
Withdrawal by Subject	1

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

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

Baseline Measures

	All Subjects
Number of Participants [units: participants]	39
Age [units: participants]
<=18 years	0
Between 18 and 65 years	25
>=65 years	14
Age, Customized [units: Years] Mean ( Full Range )	60 ( 21 to 80 )
Gender [units: participants]
Female	12
Male	27
Region of Enrollment [units: participants]
United States	39

Outcome Measures

Show All Outcome Measures

1. Primary:

1 Year Progression-free Survival Rate [ Time Frame: 1 year ]

Show Outcome Measure 1

2. Secondary:

Overall Response [ Time Frame: During the treatment period ]

Show Outcome Measure 2

3. Secondary:

Disease-free Survival in Patients With a Complete Response (CR or CRu) [ Time Frame: 10 years ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

4. Secondary:

Overall Survival [ Time Frame: 10 years ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

5. Secondary:

Secondary Malignancies [ Time Frame: 10 years ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Anne Beaven, MD
Organization: Duke University Medical Center
phone: 919-684-8964
e-mail: anne.beaven@duke.edu

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

To Top