NCT02086487

Efficacy and Safety Assessment of NIlotinib in CML Patients With Suboptimal Response on Imatinib Therapy

Efficacy and Safety Assessment of NIlotinib in CML Patients With Suboptimal Response on Imatinib Therapy (NISRI)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: King Abdullah International Medical Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

whether Nilotinib at the two sequential dosage forms will induce quicker and deeper response in those patients, and if FISH on PB (Peripheral blood) would be an effective way to monitor response compared to conventional cytogenetics on bone marrow (BM) sample

Detailed description

This is a multicenter, open label trial which will be conducted within Kingdom of saudi Arabia for which CML (Chronic Myeloid Leukemia) patients who meet eligibility criteria and showing sub optimal response to Imatinib therapy as per European leukemia Net ELN 2013 guidelines will be recruited and switched to Nilotinib 300 mg twice a day therapy. Efficacy assessments of hematologic and cytogenetic response and disease progression, will be performed every 6 months at a minimum, including hematologic analysis, bone marrow cytogenetics, and molecular studies to ensure that nilotinib is being provided to patients who were responding and that patients who progressed could discontinue therapy. Safety assessments include evaluation of adverse events, hematologic assessment, biochemical testing, cardiac enzyme assessment, serial electrocardiogram evaluation, and physical examination. Adverse events are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0. Survival will be dated from start of nilotinib therapy until death from any cause and censored at last follow-up for patients who were alive. The data will be summarized with respect to demographic and baseline characteristics, efficacy evaluation, and safety observations and measurements.

Conditions

• Myeloid Leukemia, Chronic

Interventions

Type	Name	Description
DRUG	Nilotinib 300 mg.	Patients diagnosed with chronic myeloid leukemia receiving treatment of Imatinib 400 mg once a day but are determined to be sub-optimally responding to Imatinib therapy as per the ELN 2013 guidelines will be switched to Nilotinib 300 mg BID and then will be assessed for therapy response. ELN guidelines 2013 for imatinib therapy response states as: Minor cytogenetic response mCyR or minimal response at 3 months (Ph+ metaphases in BM 35 to 95 %); BCR-ABL1 transcript \> 10% at 3 months; Partial cytogenetic response at 6 months Ph+ metaphases in BM 0to 35); BCR-ABL1 transcript is 1 to 10% at 6 months. Less than a major molecular response at \> 12 months; i.e (BCR-ABL1 0.1 -1%)

Timeline

• Start date: 2013-03-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2014-03-13
• Last updated: 2017-03-07

Locations

2 sites across 1 country: Saudi Arabia