WHO ICTRP trial
VEMURAFENIB + RITUXIMAB (VR) AS A CHEMOTHERAPY-FREE ALTERNATIVE TO CLADRIBINE +…
EUCTR2021-001864-12-IT · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2021-001864-12-IT |
|---|---|
| Public title | VEMURAFENIB + RITUXIMAB (VR) AS A CHEMOTHERAPY-FREE ALTERNATIVE TO CLADRIBINE + RITUXIMAB (CDAR) IN FRONT-LINE HAIRY CELL LEUKEMIA (HCL): A PHASE-2 RANDOMIZED MULTICENTER TRIAL |
| Scientific title | VEMURAFENIB + RITUXIMAB (VR) AS A CHEMOTHERAPY-FREE ALTERNATIVE TO CLADRIBINE + RITUXIMAB (CDAR) IN FRONT-LINE HAIRY CELL LEUKEMIA (HCL): A PHASE-2 RANDOMIZED MULTICENTER TRIAL - HCL-PG05 |
| Primary sponsor | DIPARTIMENTO DI MEDICINA, UNIVERSITà DI PERUGIA |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Italy |
| Conditions | Previously untreated patients with diagnosis of HCL MedDRA version: 21.0 Level: PT Classification code 10019053 Term: Hairy cell leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)… |
| Interventions | Trade Name: MABTHERA - 1 FIALA 500 MG 50 ML Product Name: Rituximab Product Code: [L01X- C02] Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Current Sponsor code: NA… |
| Registration date | Aug 25, 2022 |
| Target size | 120 |
| Secondary IDs | HCL-PG05 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: