This study is constituted of two stage: Treatment-Free Remission 1 (TFR1) stage and Treatment-Free Remission 2 (TFR2) stage. The purpose of the TFR1 stage is to assess the effect of nilotinib reduced to half the standard dose for 12 months on treatment-free remission in patients with Chronic Myeloid Leukemia
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 99 Years |
Gender | All |
Inclusion Criteria TFR1 stage: 1. Male and female patients 18 years or older. 2. Diagnosis of CML-CP according to the World Health Organization. 3. Patients with CML-CP under first-line treatment with nilotinib at the approved daily dose of 300 mg BID mg for at least 3 calendar years. Note: At study entry, an ongoing treatment at a dose ≥400 mg per day is allowed. 4. Sustained DMR defined as ≥ MR 4.0 (BCR-ABL level ≤0.01% IS) in all of the last 4 BCR-ABL RQ-PCR assessments with a minimum interval between each assessment of 3 months and a maximum interval of 6 months. 5. Patient must meet the following laboratory values at the screening visit:
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03874858 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Novartis Pharmaceuticals |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Italy |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Chronic Myeloid Leukemia |
This is a prospective, single arm, phase II study constituted of two stage: Treatment-Free Remission 1 (TFR1) stage and Treatment-Free Remission 2 (TFR2) stage. The TFR1 stage is made up of 4 periods: 1. Screening (week -4
Experimental: TFR1 stage- Nilotinib
During TFR1 stage, all patients will be treated with nilotinib 300 mg QD for up to 48 weeks (consolidation period). Patients with sustained DMR at the end of the consolidation period will enter the TFR1 period and nilotinib will be discontinued. Patients with loss of MMR will return to the standard nilotinib administration Patients with ≥ MMR, but without sustained DMR at the end of the consolidation period will be treated with nilotinib 300 mg QD
Experimental: TFR2 stage- Nilotinib+Asciminib
During the TFR2 stage, participants will be treated with nilotinib and asciminib for up to 96 weeks (reinduction period). Patients with sustained DMR at the end of reinduction will enter TFR2 and asciminib + nilotinib will be discontinued. Patients with ≥ MMR, but without sustained DMR, at the end of the reinduction, will be treated with nilotinib monotherapy at 300 mg BID until the end of the TFR2 stage. Patients with loss of MMR at any time during reinduction or during nilotinib monotherapy will be discontinued from the study.
Drug: - Nilotinib
Nilotinib oral 300 mg QD hard capsules
Drug: - Nilotinib
Nilotinib oral 300 mg BID hard capsules
Drug: - Asciminib
Asciminib orally at a dose of 40 mg BID film-coated tablets (FCT)
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Novartis Investigative Site
Bari, BA, 70124
Status
Recruiting
Address
Novartis Investigative Site
Bologna, BO, 40138
Status
Recruiting
Address
Novartis Investigative Site
Cagliari, CA, 09126
Status
Recruiting
Address
Novartis Investigative Site
Catania, CT, 95123
Status
Recruiting
Address
Novartis Investigative Site
Catanzaro, CZ, 88100
Status
Recruiting
Address
Novartis Investigative Site
Firenze, FI, 50134
Status
Recruiting
Address
Novartis Investigative Site
Genova, GE, 16132
Status
Recruiting
Address
Novartis Investigative Site
Milano, MI, 20122
Status
Recruiting
Address
Novartis Investigative Site
Milano, MI, 20162
Status
Recruiting
Address
Novartis Investigative Site
Palermo, PA, 90127
Status
Recruiting
Address
Novartis Investigative Site
Palermo, PA, 90146
Status
Recruiting
Address
Novartis Investigative Site
Pescara, PE, 65124
Status
Recruiting
Address
Novartis Investigative Site
Perugia, PG, 06100
Status
Recruiting
Address
Novartis Investigative Site
Pisa, PI, 56126
Status
Withdrawn
Address
Novartis Investigative Site
Ravenna, RA, 48100
Status
Recruiting
Address
Novartis Investigative Site
Reggio Emilia, RE, 42123
Status
Recruiting
Address
Novartis Investigative Site
Roma, RM, 00144
Status
Recruiting
Address
Novartis Investigative Site
Roma, RM, 00161
Status
Recruiting
Address
Novartis Investigative Site
Roma, RM, 00168
Status
Recruiting
Address
Novartis Investigative Site
Salerno, SA, 84131
Status
Recruiting
Address
Novartis Investigative Site
Siena, SI, 53100
Status
Recruiting
Address
Novartis Investigative Site
Orbassano, TO, 10043
Status
Recruiting
Address
Novartis Investigative Site
Torino, TO, 10126
Status
Recruiting
Address
Novartis Investigative Site
Torino, TO, 10128
Status
Withdrawn
Address
Novartis Investigative Site
Udine, UD, 33100
Status
Recruiting
Address
Novartis Investigative Site
Verona, VR, 37126
Status
Recruiting
Address
Novartis Investigative Site
Napoli, , 80131
Status
Recruiting
Address
Novartis Investigative Site
Napoli, , 80132
Status
Recruiting
Address
Novartis Investigative Site
Novara, , 28100