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Study of RTXM83 Plus CHOP Chemotherapy Versus a Rituximab Plus CHOP Therapy in Patients With Non Hodgkin's Lymphoma

NCT02268045 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2019-09-26

Study results available
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Summary

This is a multicenter, double-blind, randomized study comparing the efficacy, pharmacokinetics (PK)/pharmacodynamics (PD), safety and immunogenicity profile of RTXM83 (rituximab biosimilar) vs reference rituximab (MabThera®), both with CHOP, as first-line treatment of Diffuse-Large-B-Cell-Lymphoma (DLBCL).

Rituximab biosimilar and MabThera® were both administered intravenously on Day 1 of each 3-week cycle with CHOP chemotherapy for six cycles. Two additional cycles of treatment were permitted at the Investigator's discretion. Patients were followed up for 9 months after last study dose.

Conditions

  • Diffuse Large B-cell Lymphoma

Interventions

BIOLOGICAL

RTXM83

Rituximab biosimilar (RTXM83) will be administered in combination with CHOP chemotherapy regimen (Cyclophosphamide 750 mg/m2, Doxorubicin 50 mg/m2 and Vincristine 1.4 mg/m2 up to a maximum of 2 mg on Day 1 plus Prednisone 40 mg/m2 or 100 mg per day from Day 1 to 5) at a dose of 375 mg/m2 on Day 1 of each 3 week cycle, for 6 cycles, although the administration of 2 additional cycles may be allowed.

BIOLOGICAL

Mabthera

Mabthera will be administered in combination with CHOP chemotherapy regimen (Cyclophosphamide 750 mg/m2, Doxorubicin 50 mg/m2 and Vincristine 1.4 mg/m2 up to a maximum of 2 mg on Day 1 plus Prednisone 40 mg/m2 or 100 mg per day from Day 1 to 5) at a dose of 375 mg/m2 on Day 1 of each 3 week cycle, for 6 cycles, although the administration of 2 additional cycles may be allowed.

Sponsors & Collaborators

  • Pisa® Farmacéutica

    collaborator UNKNOWN

  • Laboratorios de Productos Éticos C.E.I.S.A.

    collaborator UNKNOWN

  • Laboratorio Elea Phoenix S.A.

    collaborator INDUSTRY

  • Tecnoquimicas S.A

    collaborator UNKNOWN

  • Innogene Kalbiotech Pte. Ltd

    collaborator INDUSTRY

  • Libbs Farmacêutica LTDA

    collaborator INDUSTRY

  • Key Oncologics (Pty) Ltd

    collaborator UNKNOWN

  • Nanolek LLC

    collaborator OTHER

  • Actoverco

    collaborator OTHER

  • mAbxience Research S.L.

    lead INDUSTRY

Principal Investigators

  • Susana Millán, Phd · mAbxience Research S.L.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-05-31
Completion
2017-07-31

Countries

  • Argentina
  • Brazil
  • Colombia
  • India
  • Indonesia
  • Iran
  • Malaysia
  • Mexico
  • Paraguay
  • Philippines
  • Russia
  • South Africa

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 NCT02268045 on ClinicalTrials.gov