A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-Cell Lymphoma: NHL-13

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2009 by Arbeitsgemeinschaft medikamentoese Tumortherapie.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

Hoffmann-La Roche

Information provided by:

Arbeitsgemeinschaft medikamentoese Tumortherapie

ClinicalTrials.gov Identifier:

NCT00400478

First received: November 16, 2006

Last updated: January 19, 2009

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

November 16, 2006

Last Updated Date

January 19, 2009

Start Date ^ICMJE

January 2006

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

event free survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Event-free survival

Change History

Complete list of historical versions of study NCT00400478 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

progression free survival, overall survival and safety [ Time Frame: four years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

progression free survival
overall survival

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-Cell Lymphoma: NHL-13

Official Title ^ICMJE

A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Aggressive B-Cell Lymphoma: NHL-13

Brief Summary

This is a randomized, open label, phase III study to evaluate the ability of rituximab maintenance therapy to prolong event-free survival in aggressive NHL.

Patients will be screened after successful standard induction therapy (CR or Cru following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8 cycles). Patients will be followed until an event occurs as defined in the protocol. To evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first-line therapy, measured by event-free survival (EFS), 440 patients with DLCBL or follicular NHL grade 3 (220 per arm) will be recruited.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Diffuse Large B-Cell Lymphoma (DLBCL)
Follicular NHL Grade 3b

Intervention ^ICMJE

Drug: Rituximab

Rituximab 375mg/m2 i every 8 weeks for two years (12 infusions)

Study Arm (s)

Active Comparator: A
Treatment

Intervention: Drug: Rituximab
No Intervention: B
Observation

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

600

Estimated Completion Date

December 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

4 to 8 cycles R-CHOP/like, total of 8x Rituximab
CR, CRu
ECOG/ 0.1 or 2
Known IPI at time of diagnosis
Age > 18 years
Negative pregnancy test
Men must agree not to father a child during the therapy

Exclusion Criteria:

Transformed lymphoma
Secondary malignancy
Evidence of CNS - involvement
Significant cardiac disease
Creatinine > 2.0 mg/dl
HIV, Hepatitis positive

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia, Austria, Bosnia and Herzegovina, Brazil, Bulgaria, China, Croatia, Czech Republic, Estonia, Hong Kong, Israel, Latvia, Macedonia, The Former Yugoslav Republic of, Malaysia, Mexico, Peru, Romania, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Sweden, Taiwan, Thailand, Turkey

Administrative Information

NCT Number ^ICMJE

NCT00400478

Other Study ID Numbers ^ICMJE

NHL-13 (ML18223)

Has Data Monitoring Committee

Yes

Responsible Party

Prof. Ulrich Jäger, AGMT

Study Sponsor ^ICMJE

Arbeitsgemeinschaft medikamentoese Tumortherapie

Collaborators ^ICMJE

Hoffmann-La Roche

Investigators ^ICMJE

Principal Investigator:

Ulrich Jaeger, Prof. Dr.

Medical University of Vienna

Information Provided By

Arbeitsgemeinschaft medikamentoese Tumortherapie

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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