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

• ClinicalTrials.gov Identifier: NCT00400478
• Recruitment Status: Completed
• First Posted: November 17, 2006
• Last Update Posted: May 26, 2016
• Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Collaborator: Hoffmann-La Roche
• Information provided by (Responsible Party): Arbeitsgemeinschaft medikamentoese Tumortherapie

Tracking Information

• First Submitted Date: November 16, 2006
• First Posted Date: November 17, 2006
• Last Update Posted Date: May 26, 2016
• Study Start Date: January 2006
• Actual Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 6, 2008): event free survival [ Time Frame: 4 years ]
• Original Primary Outcome Measures (submitted: November 16, 2006): Event-free survival
• Current Secondary Outcome Measures (submitted: May 6, 2008): progression free survival, overall survival and safety [ Time Frame: four years ]

Original Secondary Outcome Measures (submitted: November 16, 2006)

• progression free survival
• overall survival

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

Drug: Rituximab

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

Study Arms

• Active Comparator: A
  Treatment
  Intervention: Drug: Rituximab
• No Intervention: B
  Observation

Publications *

• Jaeger U, Trneny M, Melzer H, Praxmarer M, Nawarawong W, Ben Yehuda D, Goldstein D, Mihaljevic B, Ilhan O, Ballova V, Hedenus M, Hsiao LT, Au WY, Burgstaller S, Weidinger G, Keil F, Dittrich C, Skrabs C, Klingler A, Chott A, Fridrik MA, Greil R; AGMT-NHL13 Investigators. Rituximab maintenance for patients with aggressive B-cell lymphoma in first remission: results of the randomized NHL13 trial. Haematologica. 2015 Jul;100(7):955-63. doi: 10.3324/haematol.2015.125344. Epub 2015 Apr 24.
• Jaeger U, Praxmarer M, Greil R; AGMT-NHL13 investigators. Response to comment by P. Vassilakopoulos and colleagues. Haematologica. 2015 Nov;100(11):e482. doi: 10.3324/haematol.2015.134288. No abstract available.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 25, 2016): 683
• Original Enrollment (submitted: November 16, 2006): 440
• Actual Study Completion Date: March 2013
• Actual Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: 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
• Removed Location Countries: Former Serbia and Montenegro

Administrative Information

• NCT Number: NCT00400478
• Other Study ID Numbers: NHL-13 (ML18223)
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Original Responsible Party: Not Provided
• Current Study Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Original Study Sponsor: Same as current
• Collaborators: Hoffmann-La Roche

Investigators

• Principal Investigator: Ulrich Jaeger, Prof. Dr.; Medical University of Vienna

• PRS Account: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Verification Date: May 2016