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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pixantrone + Rituximab — DRUG
  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.
• Gemcitabine + Rituximab — DRUG
  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.

Study Details

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.

Key Dates

Start date

Apr 20, 2011

Status verified

Sep 2021

Primary completion

Jun 28, 2018

Completion

Sep 14, 2018

Study Design

Enrollment

312 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Pixantrone + Rituximab
  Pixantrone and Rituximab
• Active Comparator: Gemcitabine + Rituximab
  Gemcitabine and Rituximab

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From the date of randomization to the date of progressive disease or death due to any cause (whichever is first reported) (Up to 100 weeks) ]

Locations (51)

Find similar trials in Tucson, AZ

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