TREatment of degeNerative and Neoplastic Diseases With Rituximab

Diffuse Large B Cell Lymphoma Clinical Trial

— TREND  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01277172
• Other study ID #: PRO-1908
• Secondary ID: PRO1908TREND
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: January 8, 2011
• Last updated: January 12, 2011
• Start date: October 2010
• Est. completion date: October 2011

Study information

• Verified date: January 2011
• Source: Probiomed S.A. de C.V.
• Contact: Jorge Revilla Beltri, MD
• Phone: (00+1) 55 25811969
• Email: jorge.revilla[@]probiomed.com.mx
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Protection Against Health Risks
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Biological:
• Rituximab
375 mg/m2 IV every 2 weeks for 6 cycles
• Rituximab
375 mg/m2 IV every 2 weeks for 6 cycles
• Rituximab
375 mg/m2 IV every 2 weeks for 6 cycles
• Rituximab
375 mg/m2 IV every 14 days for 6 cycles

Locations

Country	Name	City	State
Mexico	INCan	Mexico	D.f.

Sponsors (1)

Lead Sponsor	Collaborator
Probiomed S.A. de C.V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Basal and final serum CD 20 levels comparison.	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	No
Secondary	Comparison of safety of PBO-326 versus Mabthera	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	No