WHO ICTRP trial
A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus…
LBCTR2023025267 · Lebanon Clinical Trials Registry (LBCTR) · Not Recruiting
Key facts
| Trial ID | LBCTR2023025267 |
|---|---|
| Public title | A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (=18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) |
| Scientific title | A Phase IIIb, Multi-center, Open-label, Randomized Study of Tolerability and Efficacy of Oral Asciminib Versus Nilotinib in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase - ASC4START |
| Primary sponsor | Novartis Pharma AG |
| Registry | Lebanon Clinical Trials Registry (LBCTR) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | 3 |
| Countries | France;Czech Republic;Germany;Hungary;Bulgaria;Slovakia;Canada;Greece;Italy;Malaysia;Netherlands;Oman;South Africa;Switzerland;United States of America |
| Conditions | Philadelphia Chromosome-Positive Chronic Myeloid Leukemia CML;C92.1 |
| Interventions | Drug: Asciminib Asciminib 80 mg QD administered under fasting conditions Other Name: ABL001 Drug: Nilotinib Nilotinib 300 mg BID administered under fasting conditions;Consenting, IMP administration, Laboratory testing, Imaging;Consenting… |
| Registration date | Nov 21, 2023 |
| Target size | 5 |
| Secondary IDs | NCT05147220 |
| Registry page | lbctr.moph.gov.lb |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: