Diffuse Large B-cell Lymphoma Clinical Trial
Official title:
A Randomized, Double-blind, Phase III Study Comparing Biosimilar Rituximab (RTXM83) Plus CHOP Chemotherapy Versus a Reference Rituximab Plus CHOP (R-CHOP) in Patients With Diffuse Large B-cell Lymphoma (DLBCL) Given as First Line
This is a multicenter, double-blind, randomized study comparing the efficacy,
pharmacokinetics (PK)/pharmacodynamics (PD), safety and immunogenicity profile of RTXM83
(rituximab biosimilar) vs reference rituximab (MabThera®), both with CHOP, as first-line
treatment of Diffuse-Large-B-Cell-Lymphoma (DLBCL).
Rituximab biosimilar and MabThera® were both administered intravenously on Day 1 of each
3-week cycle with CHOP chemotherapy for six cycles. Two additional cycles of treatment were
permitted at the Investigator's discretion. Patients were followed up for 9 months after last
study dose.
The primary endpoint of the investigation is to determine if the response rate obtained with
RTXM83 combined with CHOP is non inferior to the response rate obtained with reference
rituximab combined with CHOP.
The present study is a non inferiority trial and the study hypothesis is the following: H0:
pc ≥ pe + δ vs. H1: pc < pe + δ where, pe: proportion of successes in the experimental group
(RTXM83+CHOP) pc: proportion of successes in the control group (Reference Rituximab+CHOP)
Type I error: the difference pc-pe is less than δ when in fact the difference is greater than
or equal to δ ie, the investigators choose the experimental treatment when the control
treatment is actually substantially better.
Type II error: the difference -pe is greater than or equal to δ when it is actually lest than
δ ie, the investigators choose the control treatment when the experimental treatment is
essentially just as good.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT01804686 -
A Long-term Extension Study of PCI-32765 (Ibrutinib)
|
Phase 3 | |
| Recruiting |
NCT05823701 -
Chidamide, Azacitidine Combined With GM Regimen for Relapsed and Refractory DLBCL Patients
|
Phase 2 | |
| Completed |
NCT01691898 -
A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03656835 -
Nanochip Technology in Monitoring Treatment Response and Detecting Relapse in Participants With Diffuse Large B-Cell Lymphoma
|
N/A | |
| Terminated |
NCT02877082 -
Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients
|
Phase 2 | |
| Active, not recruiting |
NCT02060656 -
Phase II Study Comparing LR-GEM to R-GEM-P in Second-line Treatment of Diffuse Large B-cell Lymphoma (LEGEND)
|
Phase 2 | |
| Active, not recruiting |
NCT01653067 -
STORM: Temsirolimus, Rituximab and DHAP for Relapsed and Refractory Diffuse Large B-cell Lymphoma
|
Phase 2 | |
| Enrolling by invitation |
NCT00846157 -
Biocell Natural Killer Mixture in Diffuse Large B Cell Lymphoma (DLBCL) Patients
|
Phase 3 | |
| Completed |
NCT00440583 -
The Response Study of Yt90-Zevalin in Patients With Diffuse Large B-cell Lymphoma After 6 Cycles of CHOP
|
Phase 2 | |
| Completed |
NCT01851551 -
Phase 1/2 Study of VSLI Plus Rituximab in Patients With Relapsed and/or Refractory NHL
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04981795 -
realMIND: Observational Study on Safety and Effectiveness of Tafasitamab in Combination With Lenalidomide in Patients With Relapsed or Refractory DLBCL
|
||
| Completed |
NCT01186978 -
Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma
|
N/A | |
| Completed |
NCT01197560 -
Study of Lenalidomide to Evaluate Safety and Effectiveness in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)
|
Phase 2/Phase 3 | |
| Recruiting |
NCT03246906 -
Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation
|
Phase 2 | |
| Not yet recruiting |
NCT05990985 -
The Efficacy and Safety of the RCMOP Sequential Therapy as a First-line Treatment for Patients With Intermediate-to-high Risk Diffuse Large B-cell Lymphoma Who Had Incomplete Remission.
|
N/A | |
| Completed |
NCT02890602 -
Erythropoietin for Management of Anemia Caused by Chemotherapy
|
Phase 2 | |
| Completed |
NCT03630159 -
Study of Tisagenlecleucel in Combination With Pembrolizumab in r/r Diffuse Large B-cell Lymphoma Patients
|
Phase 1 | |
| Active, not recruiting |
NCT04529772 -
A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312)
|
Phase 3 | |
| Active, not recruiting |
NCT02900651 -
Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies
|
Phase 1 | |
| Active, not recruiting |
NCT02481310 -
Combination Chemotherapy, Rituximab, and Ixazomib Citrate in Treating Patients With Non-Hodgkin Lymphoma
|
Phase 1/Phase 2 |