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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


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
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