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
  Purpose

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.


Condition Intervention Phase
Diffuse Large B Cell Lymphoma
Biological: Rituximab
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Probiomed S.A. de C.V.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 54
Study Start Date: October 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: Rituximab
375 mg/m2 IV every 2 weeks for 6 cycles
Other Name: Monoclonal Antibody against CD20
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.
Biological: Rituximab
375 mg/m2 IV every 2 weeks for 6 cycles
Other Name: Monoclonal Antibody against CD20
Experimental: Group 3 / PBO-326
This group will be treated six cycles with PBO-326
Biological: Rituximab
375 mg/m2 IV every 2 weeks for 6 cycles
Other Name: Monoclonal Antibody against CD20
Active Comparator: Group 4 / Mabthera
This group will be treated six cycles with Mabthera
Biological: Rituximab
375 mg/m2 IV every 14 days for 6 cycles
Other Name: Monoclonal antibody against CD20

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277172

Contacts
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

Locations
Mexico
INCan Recruiting
Mexico, D.f., Mexico, 14080
Principal Investigator: Ramiro Espinoza Zamora, MD         
Sponsors and Collaborators
Probiomed S.A. de C.V.
Investigators
Study Director: Jorge Revilla Beltri, MD Probiomed S.A. de C.V.
  More Information

No publications provided

Responsible Party: Jorge Revilla Beltri, MD., Probiomed, S.A. de C.V.
ClinicalTrials.gov Identifier: NCT01277172     History of Changes
Other Study ID Numbers: PRO-1908, PRO1908TREND
Study First Received: January 8, 2011
Last Updated: January 12, 2011
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by Probiomed S.A. de C.V.:
DLBCL
pharmacokinetics
pharmacodynamics
Rituximab
LymphomaLymphoma
Non-HodgkinLymphoma
B-CellLymphoma
Large B-Cell
Disorders Lymphatic Diseases
Immunoproliferative Disorders
Antineoplastic Agents
Adverse Effects

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antibodies
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 01, 2014