TREatment of degeNerative and Neoplastic Diseases With Rituximab (TREND)

Probiomed

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Diffuse Large B Cell Lymphoma

Treatments: Biological: Rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01277172

PRO1908TREND (Other Identifier)

PRO-1908

Details and patient eligibility

About

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.

Full 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).

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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54 participants in 4 patient groups

Group 1 / PBO-326

Experimental group

Description:

This group will be treated three cycles with PBO-326, after the third cycle the patients will receive Mabthera for another three cycles.

Treatment:

Biological: Rituximab

Biological: Rituximab

Biological: Rituximab

Biological: Rituximab

Group 2 / Mabthera

Active Comparator group

Description:

This group will be treated three cycles with Mabthera, after the third cycle the patients will receive PBO-326 for another three cycles.

Treatment:

Biological: Rituximab

Biological: Rituximab

Biological: Rituximab

Biological: Rituximab

Group 3 / PBO-326

Experimental group

Description:

This group will be treated six cycles with PBO-326

Treatment:

Biological: Rituximab

Biological: Rituximab

Biological: Rituximab

Biological: Rituximab

Group 4 / Mabthera

Active Comparator group

Description:

This group will be treated six cycles with Mabthera

Treatment:

Biological: Rituximab

Biological: Rituximab

Biological: Rituximab

Biological: Rituximab