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

Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Study ID
NCT00400478
Phase
PHASE3
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 31, 2006
Status verified
May 2016
Primary completion
Mar 31, 2013
Completion
Mar 31, 2013

Study Design

Enrollment
683 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

event free survival [ Time Frame: 4 years ]

Related Studies