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TREatment of degeNerative and Neoplastic Diseases With Rituximab (TREND)

Primary Purpose

Diffuse Large B Cell Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

Mexico

Study Type

Interventional

Intervention

Rituximab

About this trial

This is an interventional treatment trial for Diffuse Large B Cell Lymphoma focused on measuring DLBCL, pharmacokinetics, pharmacodynamics, Rituximab, LymphomaLymphoma, Non-HodgkinLymphoma, B-CellLymphoma, Large B-Cell, Disorders Lymphatic Diseases, Immunoproliferative Disorders, Antineoplastic Agents, Adverse Effects

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
CD20+ lymphoma cells at screening.
> 18 years of age at screening.
Ann Arbor Stages I-IV at screening.
Any IPI score at screening.
Easten Cooperative Oncology Group (ECOG) performance status (0-2) or Karnofsky scale > 60 at screening.
Left ventricular ejection fraction > 50%.
Willing and able to provide written informed consent prior to performing study procedures.
Women of childbearing potential must use effective contraceptive methods starting from screening and until 12 months following the last infusion.

Exclusion Criteria:

Hodgkin lymphoma.
Any lymphoma other than CD20+ Diffuse Large B Cell Lymphoma (DLBCL).
Immunodeficiency syndrome or Human immunodeficiency virus (HIV) seropositivity .
Active uncontrolled infection (viral, bacterial or fungal infection) requiring systemic therapy at screening and/or at baseline visit.
Function Liver tests >2 x upper normal values.
Positive Hepatitis B surface antigen or antibodies to Hepatitis C.
Any other serious active disease or co-morbid medical condition.
Subjects who, according to the investigator, are likely to be non-compliant or uncooperative during the study.
Pregnant or breast-feeding women or women that intend to get pregnant during study or within 12 months following the last infusion.
Treatment with any investigational drug within 90 days before day 1 of study treatment.

Sites / Locations

INCanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Group 1 / PBO-326

Group 2 / Mabthera

Group 3 / PBO-326

Group 4 / Mabthera

Arm Description

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

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

This group will be treated six cycles with PBO-326

This group will be treated six cycles with Mabthera

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01277172

First Posted

January 8, 2011

Last Updated

January 12, 2011

Sponsor

Probiomed S.A. de C.V.

1. Study Identification

Unique Protocol Identification Number

NCT01277172

Brief Title

TREatment of degeNerative and Neoplastic Diseases With Rituximab

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Unknown status

Study Start Date

October 2010 (undefined)

Primary Completion Date

September 2011 (Anticipated)

Study Completion Date

October 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Probiomed S.A. de C.V.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diffuse Large B Cell Lymphoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1 / PBO-326

Arm Type

Experimental

Arm Description

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

Arm Title

Group 2 / Mabthera

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group 3 / PBO-326

Arm Type

Experimental

Arm Description

This group will be treated six cycles with PBO-326

Arm Title

Group 4 / Mabthera

Arm Type

Active Comparator

Arm Description

This group will be treated six cycles with Mabthera

Intervention Type

Biological

Intervention Name(s)

Rituximab

Other Intervention Name(s)

Monoclonal Antibody against CD20

Intervention Description

375 mg/m2 IV every 2 weeks for 6 cycles

Intervention Type

Biological

Intervention Name(s)

Rituximab

Other Intervention Name(s)

Monoclonal Antibody against CD20

Intervention Description

375 mg/m2 IV every 2 weeks for 6 cycles

Intervention Type

Biological

Intervention Name(s)

Rituximab

Other Intervention Name(s)

Monoclonal Antibody against CD20

Intervention Description

375 mg/m2 IV every 2 weeks for 6 cycles

Intervention Type

Biological

Intervention Name(s)

Rituximab

Other Intervention Name(s)

Monoclonal antibody against CD20

Intervention Description

375 mg/m2 IV every 14 days for 6 cycles

Primary Outcome Measure Information:

Title

Basal and final serum CD 20 levels comparison.

Description

Time Frame

Every 14 days for the duration of treatment

Secondary Outcome Measure Information:

Title

Comparison of safety of PBO-326 versus Mabthera

Description

Time Frame

Every 14 days measurements

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. CD20+ lymphoma cells at screening. > 18 years of age at screening. Ann Arbor Stages I-IV at screening. Any IPI score at screening. Easten Cooperative Oncology Group (ECOG) performance status (0-2) or Karnofsky scale > 60 at screening. Left ventricular ejection fraction > 50%. Willing and able to provide written informed consent prior to performing study procedures. Women of childbearing potential must use effective contraceptive methods starting from screening and until 12 months following the last infusion. Exclusion Criteria: Hodgkin lymphoma. Any lymphoma other than CD20+ Diffuse Large B Cell Lymphoma (DLBCL). Immunodeficiency syndrome or Human immunodeficiency virus (HIV) seropositivity . Active uncontrolled infection (viral, bacterial or fungal infection) requiring systemic therapy at screening and/or at baseline visit. Function Liver tests >2 x upper normal values. Positive Hepatitis B surface antigen or antibodies to Hepatitis C. Any other serious active disease or co-morbid medical condition. Subjects who, according to the investigator, are likely to be non-compliant or uncooperative during the study. Pregnant or breast-feeding women or women that intend to get pregnant during study or within 12 months following the last infusion. Treatment with any investigational drug within 90 days before day 1 of study treatment.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jorge Revilla Beltri, MD

Phone

(00+1) 55 25811969

jorge.revilla@probiomed.com.mx

First Name & Middle Initial & Last Name or Official Title & Degree

Aaron Molina Perez, MD

Phone

(00+1) 55 25811924

ignacio.molina@probiomed.com.mx

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jorge Revilla Beltri, MD

Organizational Affiliation

Probiomed S.A. de C.V.

Official's Role

Study Director

Facility Information:

Facility Name

INCan

City

Mexico

State/Province

D.f.

ZIP/Postal Code

14080

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ramiro Espinoza Zamora, MD

12. IPD Sharing Statement

Learn more about this trial

TREatment of degeNerative and Neoplastic Diseases With Rituximab

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