TREatment of degeNerative and Neoplastic Diseases With Rituximab

NCT ID: NCT01277172

Last Updated: 2011-01-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-10-31

Brief Summary

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.

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).

Conditions

Diffuse Large B Cell Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Rituximab

Intervention Type: BIOLOGICAL

375 mg/m2 IV every 2 weeks for 6 cycles

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.

Group Type: ACTIVE_COMPARATOR

Rituximab

Intervention Type: BIOLOGICAL

375 mg/m2 IV every 2 weeks for 6 cycles

Group 3 / PBO-326

This group will be treated six cycles with PBO-326

Group Type: EXPERIMENTAL

Rituximab

Intervention Type: BIOLOGICAL

375 mg/m2 IV every 2 weeks for 6 cycles

Group 4 / Mabthera

This group will be treated six cycles with Mabthera

Group Type: ACTIVE_COMPARATOR

Rituximab

Intervention Type: BIOLOGICAL

375 mg/m2 IV every 14 days for 6 cycles

Interventions

Rituximab

375 mg/m2 IV every 2 weeks for 6 cycles

Intervention Type: BIOLOGICAL

Rituximab

375 mg/m2 IV every 2 weeks for 6 cycles

Intervention Type: BIOLOGICAL

Rituximab

375 mg/m2 IV every 2 weeks for 6 cycles

Intervention Type: BIOLOGICAL

Rituximab

375 mg/m2 IV every 14 days for 6 cycles

Intervention Type: BIOLOGICAL

Other Intervention Names

Monoclonal Antibody against CD20; Monoclonal Antibody against CD20; Monoclonal Antibody against CD20; Monoclonal antibody against CD20

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Probiomed S.A. de C.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Probiomed, S.A. de C.V.

Principal Investigators

Jorge Revilla Beltri, MD

Role: STUDY_DIRECTOR

Probiomed S.A. de C.V.

Locations

INCan

México, D.f., Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Jorge Revilla Beltri, MD

Role: CONTACT

jorge.revilla@probiomed.com.mx

(00+1) 55 25811969

Aaron Molina Perez, MD

Role: CONTACT

ignacio.molina@probiomed.com.mx

(00+1) 55 25811924

Other Identifiers

PRO1908TREND

Identifier Type: OTHER

Identifier Source: secondary_id

PRO-1908

Identifier Type: -

Identifier Source: org_study_id