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

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT00400478
First received: November 16, 2006
Last updated: May 25, 2016
Last verified: May 2016

November 16, 2006
May 25, 2016
January 2006
March 2013   (final data collection date for primary outcome measure)
event free survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
event free survival
Complete list of historical versions of study NCT00400478 on ClinicalTrials.gov Archive Site
progression free survival, overall survival and safety [ Time Frame: four years ] [ Designated as safety issue: Yes ]
  • progression free survival
  • overall survival
Not Provided
Not Provided
 
A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13
A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Aggressive B-cell Lymphoma: NHL-13

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diffuse Large B-Cell Lymphoma (DLBCL)
  • Follicular NHL Grade 3b
Drug: Rituximab
Rituximab 375mg/m2 i every 8 weeks for two years (12 infusions)
  • Active Comparator: A
    Treatment
    Intervention: Drug: Rituximab
  • No Intervention: B
    Observation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
683
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
Former Serbia and Montenegro
 
NCT00400478
NHL-13 (ML18223)
Yes
Not Provided
Not Provided
Arbeitsgemeinschaft medikamentoese Tumortherapie
Arbeitsgemeinschaft medikamentoese Tumortherapie
Hoffmann-La Roche
Principal Investigator: Ulrich Jaeger, Prof. Dr. Medical University of Vienna
Arbeitsgemeinschaft medikamentoese Tumortherapie
May 2016

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