TREatment of degeNerative and Neoplastic Diseases With Rituximab

Phase 2

• Conditions: Diffuse Large B Cell Lymphoma
• Interventions: Biological: Rituximab

• Registration Number: NCT01277172
• Lead Sponsor: Probiomed S.A. de C.V.

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).

Study Timeline

• Study Start: 2010-10
• Status Verified: 2011-01
• Study First Submitted: 2011-01-08
• Study First Submitted QC: 2011-01-12
• Last Update Submitted: 2011-01-12
• Study First Posted: 2011-01-14
• Last Update Posted: 2011-01-14
• Primary Completion: 2011-09
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1 / PBO-326	Rituximab	This group will be treated three cycles with PBO-326, after the third cycle the patients will receive Mabthera for another three cycles.
Group 4 / Mabthera	Rituximab	This group will be treated six cycles with Mabthera
Group 2 / Mabthera	Rituximab	This group will be treated three cycles with Mabthera, after the third cycle the patients will receive PBO-326 for another three cycles.
Group 3 / PBO-326	Rituximab	This group will be treated six cycles with PBO-326

Primary Outcome Measures

Name	Time	Method
Basal and final serum CD 20 levels comparison.	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.

Secondary Outcome Measures

Name	Time	Method
Comparison of safety of PBO-326 versus Mabthera	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.

Trial Locations

Locations (1)

INCan; 🇲🇽 Mexico, D.f., Mexico