TREatment of degeNerative and Neoplastic Diseases With Rituximab
TREND
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
2 other identifiers
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 8, 2011
CompletedFirst Posted
Study publicly available on registry
January 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedJanuary 14, 2011
January 1, 2011
11 months
January 8, 2011
January 12, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Comparison of safety of PBO-326 versus Mabthera
Every 14 days measurements
Study Arms (4)
Group 1 / PBO-326
EXPERIMENTALThis group will be treated three cycles with PBO-326, after the third cycle the patients will receive Mabthera for another three cycles.
Group 2 / Mabthera
ACTIVE COMPARATORThis group will be treated three cycles with Mabthera, after the third cycle the patients will receive PBO-326 for another three cycles.
Group 3 / PBO-326
EXPERIMENTALThis group will be treated six cycles with PBO-326
Group 4 / Mabthera
ACTIVE COMPARATORThis group will be treated six cycles with Mabthera
Interventions
375 mg/m2 IV every 2 weeks for 6 cycles
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
INCan
México, D.f., 14080, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jorge Revilla Beltri, MD
Probiomed S.A. de C.V.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 8, 2011
First Posted
January 14, 2011
Study Start
October 1, 2010
Primary Completion
September 1, 2011
Study Completion
October 1, 2011
Last Updated
January 14, 2011
Record last verified: 2011-01