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Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy

NCT01077518 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 346

Last updated 2020-03-27

Study results available
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Summary

The purpose of this study was to evaluate the safety and efficacy of ofatumumab and bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.

Conditions

  • Lymphoma, Follicular

Interventions

DRUG

Ofatumumab

Ofatumumab was a liquid concentrate solution for infusion presented in glass vials containing 50 mL of solution at a concentration of 20 mg/mL to provide 1000 mg per vial. The ofatumumab infusions were prepared in 1000 mL sterile, pyrogen-free 0.9% NaCl to yield a 1 mg/mL ofatumumab concentration infusion.

DRUG

Bendamustine infusion

Bendamustine 100 mg/vial, injection

DRUG

Ofatumumab and Bendamustine infusions (Arm A)

Up to 8 cycles of Bendamustine (90 mg/m2 Days 1 and 2, every 21 days) given in combination with 12 doses of ofatumumab (1000 mg). Ofatumumab will be given on day 1 of each cycle of bendamustine as long as patients in Arm A receive bendamustine. Once patients in Arm A complete bendamustine therapy, the remaining doses of ofatumumab will be given monthly until all 12 doses are completed.

DRUG

Bendamustine infusion (Arm B)

Bendamustine (120 mg/m2 Days 1 and 2, every 21 days, up to 8 cycles).

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-26
Primary Completion
2018-01-03
Completion
2018-12-26
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • Canada
  • France
  • Germany
  • Greece
  • Hong Kong
  • Italy
  • Japan
  • Poland
  • Puerto Rico
  • Russia
  • Slovakia
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01077518 on ClinicalTrials.gov