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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


Phase 2/Phase 3
18 Years
80 Years
Open (Enrolling)
Both
Diffuse Large B Cell Lymphoma

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Trial Information

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


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).


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Basal and final serum CD 20 levels comparison.

Outcome Description:

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.

Outcome Time Frame:

Every 14 days for the duration of treatment

Safety Issue:

No

Principal Investigator

Jorge Revilla Beltri, MD

Investigator Role:

Study Director

Investigator Affiliation:

Probiomed S.A. de C.V.

Authority:

Mexico: Federal Commission for Protection Against Health Risks

Study ID:

PRO-1908

NCT ID:

NCT01277172

Start Date:

October 2010

Completion Date:

October 2011

Related Keywords:

  • Diffuse Large B Cell Lymphoma
  • DLBCL
  • pharmacokinetics
  • pharmacodynamics
  • Rituximab
  • LymphomaLymphoma
  • Non-HodgkinLymphoma
  • B-CellLymphoma
  • Large B-Cell
  • Disorders Lymphatic Diseases
  • Immunoproliferative Disorders
  • Antineoplastic Agents
  • Adverse Effects
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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