Trial record 12 of 1600 for:
Open Studies | "Lymphatic Diseases"
TREatment of degeNerative and Neoplastic Diseases With Rituximab (TREND)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Probiomed S.A. de C.V..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Probiomed S.A. de C.V.
Information provided by:
Probiomed S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT01277172
First received: January 8, 2011
Last updated: January 12, 2011
Last verified: January 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diffuse Large B Cell Lymphoma |
Biological: Rituximab |
Phase 2 Phase 3 |
| Study Type: | 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 |
| 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 |
Resource links provided by NLM:
Further study details as provided by Probiomed S.A. de C.V.:
Primary Outcome Measures:
- Basal and final serum CD 20 levels comparison. [ Time Frame: Every 14 days for the duration of treatment ] [ Designated as safety issue: No ]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 [ Time Frame: Every 14 days measurements ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 54 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1 / PBO-326
This group will be treated three cycles with PBO-326, after the third cycle the patients will receive Mabthera for another three cycles.
|
Biological: Rituximab
375 mg/m2 IV every 2 weeks for 6 cycles
Other Name: Monoclonal Antibody against CD20
|
|
Active Comparator: Group 2 / Mabthera
This group will be treated three cycles with Mabthera, after the third cycle the patients will receive PBO-326 for another three cycles.
|
Biological: Rituximab
375 mg/m2 IV every 2 weeks for 6 cycles
Other Name: Monoclonal Antibody against CD20
|
|
Experimental: Group 3 / PBO-326
This group will be treated six cycles with PBO-326
|
Biological: Rituximab
375 mg/m2 IV every 2 weeks for 6 cycles
Other Name: Monoclonal Antibody against CD20
|
|
Active Comparator: Group 4 / Mabthera
This group will be treated six cycles with Mabthera
|
Biological: Rituximab
375 mg/m2 IV every 14 days for 6 cycles
Other Name: Monoclonal antibody against CD20
|
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).
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01277172
Contacts
| Contact: Jorge Revilla Beltri, MD | (00+1) 55 25811969 | jorge.revilla@probiomed.com.mx |
| Contact: Aaron Molina Perez, MD | (00+1) 55 25811924 | ignacio.molina@probiomed.com.mx |
Locations
| Mexico | |
| INCan | Recruiting |
| Mexico, D.f., Mexico, 14080 | |
| Principal Investigator: Ramiro Espinoza Zamora, MD | |
Sponsors and Collaborators
Probiomed S.A. de C.V.
Investigators
| Study Director: | Jorge Revilla Beltri, MD | Probiomed S.A. de C.V. |
More Information
No publications provided
| Responsible Party: | Jorge Revilla Beltri, MD., Probiomed, S.A. de C.V. |
| ClinicalTrials.gov Identifier: | NCT01277172 History of Changes |
| Other Study ID Numbers: | PRO-1908, PRO1908TREND |
| Study First Received: | January 8, 2011 |
| Last Updated: | January 12, 2011 |
| Health Authority: | Mexico: Federal Commission for Protection Against Health Risks |
Keywords provided by Probiomed S.A. de C.V.:
|
Disorders Lymphatic Diseases DLBCL pharmacokinetics pharmacodynamics Rituximab LymphomaLymphoma |
Non-HodgkinLymphoma B-CellLymphoma Large B-Cell Immunoproliferative Disorders Antineoplastic Agents Adverse Effects |
Additional relevant MeSH terms:
|
Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |
Antibodies Antibodies, Monoclonal Rituximab Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 19, 2013