Clinical trial · Interventional
TREatment of degeNerative and Neoplastic Diseases With Rituximab
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Group 1 / PBO-326
- description
- This group will be treated three cycles with PBO-326, after the third cycle the patients will receive Mabthera for another three cycles.
- interventionNames
- Biological: Rituximab
- type
- ACTIVE_COMPARATOR
- label
- Group 2 / Mabthera
- description
- This group will be treated three cycles with Mabthera, after the third cycle the patients will receive PBO-326 for another three cycles.
- interventionNames
- Biological: Rituximab
- type
- EXPERIMENTAL
- label
- Group 3 / PBO-326
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available