Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Paracetamol · 1 trial · 1 indication
For this pharmacokinetics (PK) primary outcome measure the serum rituximab Ctrough for SC and IV administrations were measured at Cycle 7, 21 days after study treatment administration for Cycle 7 (pre-dose of Cycle 8). Geometric mean ratio and 90% confidence interval were estimated based on an ANCOVA model adjusted for tumor load at baseline and are reported in the statistical analysis.
| Arm | Type | Description |
|---|---|---|
| Rituximab IV+CHOP | ACTIVE_COMPARATOR | Participants will receive 8 cycles of IV rituximab in combination with 6 or 8 cycles of CHOP chemotherapy administered every 3 weeks. |
| Rituximab SC+CHOP | EXPERIMENTAL | Participants will receive 1 cycle of IV plus 7 cycles of SC rituximab in combination with 6 or 8 cycles of CHOP chemotherapy administered every 3 weeks. |
| Name | Type | Description |
|---|---|---|
| Rituximab IV | DRUG | Rituximab will be administered intravenously through Cycle 1-8 at a standard dose of 375 mg/m\^2 (milligram per square meter). |
| Rituximab SC | DRUG | Rituximab will be administered subcutaneously through Cycle 2-8 at a dose of 1400 milligram (mg). |
| Cyclophosphamide | DRUG | Cyclophosphamide will be administered IV at a dose of 750 mg/m\^2 |
| Doxorubicin | DRUG | Doxorubicin will be administered IV at a dose of 50 mg/m\^2 |
| Vincristine | DRUG | Vincristine will be administered IV at a dose of 1.4 mg/m\^2 |
| Prednisone | DRUG | Prednisone will be administered orally at a dose of 100 mg/day |
| Paracetamol | DRUG | All participants are required to receive 1000 mg oral paracetamol as premedication prior to starting each infusion of rituximab |
| Diphenhydramine hydrochloride or alternative antihistamine | DRUG | All participants are required to receive 50-100 mg oral diphenhydramine hydrochloride or alternative antihistamine as premedication prior to starting each infusion of rituximab |
Inclusion Criteria: * Previously untreated CD20 positive diffuse large B-cell lymphoma (DLBCL) * Participants with an International Prognostic Index (IPI) score of 1 to 5 or IPI score of 0 with bulky disease, defined as one lesion \>/=7.5 cm * At least one bi-dimensionally measurable lesion defined...
Paracetamol is an investigational small molecule being studied for the treatment of diffuse large B-cell lymphoma (DLBCL), a type of non-Hodgkin lymphoma. It is currently in Phase 2 clinical development for this indication, though it is not yet approved for this use.
Paracetamol is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this drug for the treatment of diffuse large B-cell lymphoma.
Paracetamol is in Phase 2 clinical development for diffuse large B-cell lymphoma. It is an investigational drug and has not been approved by regulatory authorities for this indication. One Phase 2 trial has been completed.
Paracetamol has been studied in one completed Phase 2 clinical trial, identified as NCT04660799. This trial evaluated the drug in combination with CHOP chemotherapy in 50 previously untreated participants with CD20 positive diffuse large B-cell lymphoma in China.
No, Paracetamol is not the same as Rituximab. In the clinical trial NCT04660799, Paracetamol was studied in combination with rituximab and CHOP chemotherapy. Paracetamol is a separate investigational drug being developed by Roche for diffuse large B-cell lymphoma.