An open label, Phase I dose escalation clinical trial of NRC-AN-019 in patients with all phases of Chronic Myeloid Leukemia, who are resistant or intolerant to Imatinib mesylate

ATCO Pharma LimitedNATCO HouseRoad Banjara HillsHyderabad0 个研究点目标入组 41 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Male and Female patients in an age group between 18 to 65 years
•2. CML patients with Philadelphia positive chronic or accelerated or blast crisis phase
•3. Imatinib resistant or intolerant patients
•4. Patients who are willing and able to give the informed consent
•5. Eastern Cooperative Oncology Group (ECOG) performance status < or = 2

•1. Patients with cytogenetic or molecular resistance, but without hematologic resistance to Imatinib.
•2. Patients who are pregnant, lactating or planning to conceive a child in the period surrounding the study
•3. History of AIDS or tested HIV positive
•4. Patients with psychiatric disorder.
•5. Patients with comorbid medical conditions like uncontrolled diabetes, conduction system abnormality (first, second or third degree block, bundle branch block or arrhythmias) or any other serious medical conditions or is on medications known to affect the cardiac conduction system (e.g. beta blockers, digoxin or other anti-arrhythmics, calcium channel blockers)
•6. Patients currently involved in any other clinical trial.

发起方

ATCO Pharma LimitedNATCO HouseRoad Banjara HillsHyderabad