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

This study is ongoing, but not recruiting participants.

First Received on November 16, 2006. Last Updated on January 19, 2009 History of Changes

Sponsor:	Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborator:	Hoffmann-La Roche
Information provided by:	Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:	NCT00400478

Purpose

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.

Condition	Intervention	Phase
Diffuse Large B-Cell Lymphoma (DLBCL) Follicular NHL Grade 3b	Drug: Rituximab	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Aggressive B-Cell Lymphoma: NHL-13

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab

U.S. FDA Resources

Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	600
Study Start Date:	January 2006
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A Treatment	Drug: Rituximab Rituximab 375mg/m2 i every 8 weeks for two years (12 infusions)
No Intervention: B Observation

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400478

Show 131 Study Locations

Sponsors and Collaborators

Arbeitsgemeinschaft medikamentoese Tumortherapie

Hoffmann-La Roche

Investigators

Principal Investigator:

Ulrich Jaeger, Prof. Dr.

Medical University of Vienna

More Information

No publications provided

Responsible Party:	Prof. Ulrich Jäger, AGMT
ClinicalTrials.gov Identifier:	NCT00400478 History of Changes
Other Study ID Numbers:	NHL-13 (ML18223)
Study First Received:	November 16, 2006
Last Updated:	January 19, 2009
Health Authority:	Austria: Ethikkommission

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

DLBCL
NHL 13
Rituximab
maintenance

Additional relevant MeSH terms:

Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

Lymphoma, Non-Hodgkin
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 24, 2012