TREatment of degeNerative and Neoplastic Diseases With Rituximab

Sponsor
Probiomed S.A. de C.V.
Study ID
NCT01277172
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — BIOLOGICAL
    375 mg/m2 IV every 2 weeks for 6 cycles
  • Rituximab — BIOLOGICAL
    375 mg/m2 IV every 2 weeks for 6 cycles
  • Rituximab — BIOLOGICAL
    375 mg/m2 IV every 2 weeks for 6 cycles
  • Rituximab — BIOLOGICAL
    375 mg/m2 IV every 14 days for 6 cycles

Study Details

This is a prospective international, multi-center, randomized, double-blind controlled study designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety of PBO-326 (Rituximab) and Mabthera (Rituximab) in combination with CHOP in previously untreated patients with diffuse B cells Non Hodgkin lymphoma.

Key Dates

Start date
Oct 31, 2010
Status verified
Jan 2011
Primary completion
Sep 30, 2011
Completion
Oct 31, 2011

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1 / PBO-326
    This group will be treated three cycles with PBO-326, after the third cycle the patients will receive Mabthera for another three cycles.
  • Active Comparator: Group 2 / Mabthera
    This group will be treated three cycles with Mabthera, after the third cycle the patients will receive PBO-326 for another three cycles.
  • Experimental: Group 3 / PBO-326
    This group will be treated six cycles with PBO-326
  • Active Comparator: Group 4 / Mabthera
    This group will be treated six cycles with Mabthera

Primary Outcome Measure

Basal and final serum CD 20 levels comparison. [ Time Frame: Every 14 days for the duration of treatment ]

Central Contacts

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