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Comparison of Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma or Follicular Grade 3 Lymphoma Who Have Relapsed After Therapy and Are Not Eligible for Stem Cell Transplant

NCT01321541 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2021-11-19

Study results available
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Summary

The purpose of this study is to evaluate the efficacy of Pixantrone + Rituximab compared to Gemcitabine + Rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), or follicular grade 3 lymphoma.

Conditions

  • Diffuse Large B-cell Lymphoma
  • de Novo DLBCL
  • DLBCL Transformed From Indolent Lymphoma
  • Follicular Grade 3 Lymphoma

Interventions

DRUG

Pixantrone + Rituximab

Pixantrone + Rituximab: Rituximab 375 mg/m2 IV on day 1 and pixantrone 50 mg/m2 (equivalent to 85mg/m2 pixantrone dimaleate)IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.

DRUG

Gemcitabine + Rituximab

Gemcitabine + Rituximab: Rituximab 375 mg/m2 IV on day 1 and gemcitabine 1000 mg/m2 IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.

Sponsors & Collaborators

  • CTI BioPharma

    lead INDUSTRY

Principal Investigators

  • Simran B Singh, MS, GWCP · Sr. Director, Clinical Operations

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-20
Primary Completion
2018-06-28
Completion
2018-09-14

Countries

  • United States
  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • Romania
  • Russia
  • Slovakia
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

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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 NCT01321541 on ClinicalTrials.gov