FindTrial
Sign In

Randomized Open Label of Ofatumumab and Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin's Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment

Randomized Open Label of Ofatumumab and Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin's Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221922
Enrollment
346
Registered
2012-09-18
Start date
2012-10-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

indolent B-cell NHL

Interventions

investigational material(s) Generic name etc : GSK1841157 INN of investigational material : Ofatumumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigatio

Sponsors

Novartis
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Indolent B-cell Non-Hodgkin's Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment

Exclusion criteria

Exclusion criteria: Grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed to aggressive lymphoma

Design outcomes

Primary

MeasureTime frame
safety efficacy Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)—

Secondary

MeasureTime frame
safety efficacy Overall Response Rate, Overall Survival—

Countries

Asia except Japan, Europe, Japan, North America, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026