Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
First line chemotherapy · 1 trial · 1 indication
CR was defined by: a) disappearance of clinical/radiographic evidence of disease, disease-related symptoms, and biochemical abnormalities; b) decrease in lymph nodes (LNs) greater than (\>) 1.5 centimeters (cm) in greatest transverse diameter (GTD) to less than (\<) 1.5 cm, a decrease in LNs 1.1 - 1.5 cm to 1 cm or 75 percent (%) decrease in sum of the products of GTD (SPD); c) non-palpable spleen, decreased size of enlarged organs, and disappearance of nodules; and d) disappearance of bone marrow (BM) infiltrate. CR(u) was defined as fulfilling a) and c), above, with greater than or equal to (≥) 1 of the following: a) \> 75% decrease in SPD of LNs \> 1.5 cm, and \> 75% decrease in SPD of previously confluent LNs; b) indeterminate BM, or c) confirmed CR. PR was defined by: a) 50% decrease in SPD of the 6 largest LNs; b) no increase in LNs, liver, or spleen size; c) ≥ 50% decrease in splenic and hepatic nodule SPDs; d) no measurable disease in other organs; and e) no new sites of disease.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| rituximab [MabThera/Rituxan] | DRUG | 375mg/m2 iv every 3 weeks |
| First line chemotherapy | DRUG | As prescribed |
Inclusion Criteria: * histologically-proven mantle cell lymphoma; * previously untreated disease at stage II, III and IV, requiring therapy. Exclusion Criteria: * known hypersensitivity reaction to rituximab, or known anti-murine antibody reactivity or known hypersensitivity to murine antibodies;...
First line chemotherapy is an investigational small molecule being studied for the treatment of Mantle Cell Lymphoma. It is intended as an initial treatment for patients with this condition. The drug is currently in clinical development and has not been approved by regulatory authorities.
First line chemotherapy is being developed by Roche Holding AG, a biopharmaceutical company. The company's stock is traded under the ticker symbol RHHBY. Roche is conducting clinical trials to evaluate the safety and efficacy of this drug in patients with Mantle Cell Lymphoma.
First line chemotherapy is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. The drug is being studied for the treatment of Mantle Cell Lymphoma, and its safety and efficacy are still being evaluated in clinical trials.
First line chemotherapy has been studied in one clinical trial, identified as NCT00472420. This Phase 2 study, titled 'A Study of MabThera (Rituximab) Plus Standard Chemotherapy in Patients With Previously Untreated Mantle Cell Lymphoma,' was conducted in Hungary and enrolled 48 participants. The trial has been completed.
First line chemotherapy is not the same as MabThera. The clinical trial NCT00472420 studied the combination of MabThera (rituximab) plus standard chemotherapy, which includes First line chemotherapy. First line chemotherapy is a separate drug being evaluated as part of this combination regimen for Mantle Cell Lymphoma.