Diffuse Large B Cell Lymphoma Clinical Trial
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
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.
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).
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04670029 -
Impact of an APA Program on EFS in Patients With Diffuse Large-cell B Lymphoma Treated in 1st Line
|
Phase 3 | |
| Active, not recruiting |
NCT04526834 -
Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma
|
Phase 1 | |
| Active, not recruiting |
NCT04572763 -
Copanlisib Plus Venetoclax in R/R DLBCL
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03676504 -
Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05365659 -
IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas
|
Phase 1 | |
| Completed |
NCT03287817 -
CD19/22 CAR T Cells (AUTO3) for the Treatment of Diffuse Large B Cell Lymphoma
|
Phase 1/Phase 2 | |
| Enrolling by invitation |
NCT05645744 -
Long-term Follow-up Study in Patients Previously Treated With a Mustang Bio CAR-T Cell Investigational Product.
|
||
| Completed |
NCT04316624 -
A Study of C-CAR066 in Subjects With r/r Diffuse Large B Cell Lymphoma Who Received CD19 CAR-T Therapy
|
Phase 1 | |
| Active, not recruiting |
NCT04555811 -
FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL
|
Phase 1 | |
| Terminated |
NCT04189952 -
Acalabrutinib in Combination With R-ICE For Relapsed or Refractory Lymphoma
|
Phase 2 | |
| Recruiting |
NCT01949818 -
Treatment of Diffuse Large B Cell Lymphoma
|
Phase 4 | |
| Completed |
NCT01459887 -
Study of Recombinant Human-Mouse Chimeric Anti-CD20 Monoclonal Antibody to Treat Non-hodgkin's Lymphoma
|
Phase 3 | |
| Completed |
NCT03242902 -
To Decrease Fatigue With Light Therapy
|
Phase 3 | |
| Recruiting |
NCT04104776 -
A Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05018520 -
The Safety and Effectiveness of 4R-CHOP+4R vs 6R-CHOP+2R in Newly Diagnosed Patients With DLBCL in Low Risk
|
Phase 3 | |
| Withdrawn |
NCT04052061 -
QUILT-3.061: CD19 t-haNK in Subjects With Diffuse Large B-Cell Lymphoma
|
Phase 1 | |
| Recruiting |
NCT05020392 -
Autologous Cells Derived Anti-CD19 CAR-Engineered T Cells With Concurrent BTK Inhibitor for B Cell Lymphoma
|
Phase 3 | |
| Recruiting |
NCT05006716 -
A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
|
Phase 1/Phase 2 | |
| Completed |
NCT03297424 -
A Study of PLX2853 in Advanced Malignancies.
|
Phase 1 | |
| Recruiting |
NCT04545762 -
Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma
|
Phase 1 |