TREatment of degeNerative and Neoplastic Diseases With Rituximab (TREND)

January 12, 2011 updated by: Probiomed S.A. de C.V.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • D.f.
      • Mexico, D.f., Mexico, 14080
        • Recruiting
        • INCAN
        • Principal Investigator:
          • Ramiro Espinoza Zamora, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Monoclonal Antibody against CD20
Biological: Rituximab
375 mg/m2 IV every 14 days for 6 cycles
Other Names:
  • 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 Names:
  • Monoclonal Antibody against CD20
Biological: Rituximab
375 mg/m2 IV every 14 days for 6 cycles
Other Names:
  • 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 Names:
  • Monoclonal Antibody against CD20
Biological: Rituximab
375 mg/m2 IV every 14 days for 6 cycles
Other Names:
  • 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 2 weeks for 6 cycles
Other Names:
  • Monoclonal Antibody against CD20
Biological: Rituximab
375 mg/m2 IV every 14 days for 6 cycles
Other Names:
  • Monoclonal antibody against CD20

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of safety of PBO-326 versus Mabthera
Time Frame: Every 14 days measurements
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.
Every 14 days measurements

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Probiomed S.A. de C.V.

Investigators

  • Study Director: Jorge Revilla Beltri, MD, Probiomed S.A. de C.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

September 1, 2011

Study Completion (Anticipated)

October 1, 2011

Study Registration Dates

First Submitted

January 8, 2011

First Submitted That Met QC Criteria

January 12, 2011

First Posted (Estimate)

January 14, 2011

Study Record Updates

Last Update Posted (Estimate)

January 14, 2011

Last Update Submitted That Met QC Criteria

January 12, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-1908
  • PRO1908TREND (Other Identifier: PRO1908TREND012011)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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