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TREatment of degeNerative and Neoplastic Diseases With Rituximab (TREND)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Probiomed S.A. de C.V..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Probiomed S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT01277172
First received: January 8, 2011
Last updated: January 12, 2011
Last verified: January 2011

January 8, 2011
January 12, 2011
October 2010
September 2011   (final data collection date for primary outcome measure)
Basal and final serum CD 20 levels comparison. [ Time Frame: Every 14 days for the duration of treatment ] [ Designated as safety issue: No ]
Primary outcome is the depletion of CD20+ B cells. This will be measured every 14 days and comparison will be made basal levels versus visit 2, visit 3, visit 4, visit 5, visit 6, visit 7 and visit 8.
Same as current
Complete list of historical versions of study NCT01277172 on ClinicalTrials.gov Archive Site
Comparison of safety of PBO-326 versus Mabthera [ Time Frame: Every 14 days measurements ] [ Designated as safety issue: No ]
Adverse events will be observed and recorded in relation to acute infusion events (number of cases and severity of hypotension, hipertension, headache, and all cardiovascular events previously reported by Mabthera) as well as long term effects over key hematological cells (number of cases and severity of neutropenia, trombocytopenia, leucopenia) per visit.
Same as current
Not Provided
Not Provided
 
TREatment of degeNerative and Neoplastic Diseases With Rituximab
Comparative,Randomized,Double Blind Study to Evaluate Biologic Effect and Safety of PBO-326 (Rituximab), Associated to CHOP-14 Compared With Mabthera (Rituximab) Associated to CHOP-14 in B Cells CD20+ Diffuse Non-Hodgkin Lymphoma Patients

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.

At present R-CHOP (Rituximab plus Cyclofosfamide, Doxorrubicine, Vincristine and Prednisone) has became standard of care of patients with B cells Non Hodgkin Lymphoma CD20+.

Study will perform pharmacodynamic (PD) and pharmacokinetic (PK) measurment of a novel Rituximab in comparison with Mabthera and evaluates safety both metabolic as well immunologic.

Study protocolo is designed to provide data on impact of treatment interchange of both study drugs (PBO-326 and Mabthera).

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diffuse Large B Cell Lymphoma
  • Biological: Rituximab
    375 mg/m2 IV every 2 weeks for 6 cycles
    Other Name: Monoclonal Antibody against CD20
  • Biological: Rituximab
    375 mg/m2 IV every 14 days for 6 cycles
    Other Name: Monoclonal antibody against CD20
  • 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.
    Intervention: Biological: Rituximab
  • 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.
    Intervention: Biological: Rituximab
  • Experimental: Group 3 / PBO-326
    This group will be treated six cycles with PBO-326
    Intervention: Biological: Rituximab
  • Active Comparator: Group 4 / Mabthera
    This group will be treated six cycles with Mabthera
    Intervention: Biological: Rituximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
54
October 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Newly diagnosed subjects with a confirmed pathologic diagnosis of diffuse large B cell non-Hodgkin's lymphoma (DLBCL) based on the 2008 World Health Organization classification.
  2. CD20+ lymphoma cells at screening.
  3. > 18 years of age at screening.
  4. Ann Arbor Stages I-IV at screening.
  5. Any IPI score at screening.
  6. Easten Cooperative Oncology Group (ECOG) performance status (0-2) or Karnofsky scale > 60 at screening.
  7. Left ventricular ejection fraction > 50%.
  8. Willing and able to provide written informed consent prior to performing study procedures.
  9. Women of childbearing potential must use effective contraceptive methods starting from screening and until 12 months following the last infusion.

Exclusion Criteria:

  1. Hodgkin lymphoma.
  2. Any lymphoma other than CD20+ Diffuse Large B Cell Lymphoma (DLBCL).
  3. Immunodeficiency syndrome or Human immunodeficiency virus (HIV) seropositivity .
  4. Active uncontrolled infection (viral, bacterial or fungal infection) requiring systemic therapy at screening and/or at baseline visit.
  5. Function Liver tests >2 x upper normal values.
  6. Positive Hepatitis B surface antigen or antibodies to Hepatitis C.
  7. Any other serious active disease or co-morbid medical condition.
  8. Subjects who, according to the investigator, are likely to be non-compliant or uncooperative during the study.
  9. Pregnant or breast-feeding women or women that intend to get pregnant during study or within 12 months following the last infusion.
  10. Treatment with any investigational drug within 90 days before day 1 of study treatment.
Both
18 Years to 80 Years
No
Contact: Jorge Revilla Beltri, MD (00+1) 55 25811969 jorge.revilla@probiomed.com.mx
Contact: Aaron Molina Perez, MD (00+1) 55 25811924 ignacio.molina@probiomed.com.mx
Mexico
 
NCT01277172
PRO-1908, PRO1908TREND
Yes
Jorge Revilla Beltri, MD., Probiomed, S.A. de C.V.
Probiomed S.A. de C.V.
Not Provided
Study Director: Jorge Revilla Beltri, MD Probiomed S.A. de C.V.
Probiomed S.A. de C.V.
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP