A clinical trial to study the safety and efficacy of NRC-AN-019 in patients with chronic Myeloid Leukemia who are not responding or intolerant to Imatinib mesylate
- Conditions
- Health Condition 1: C921- Chronic myeloid leukemia, BCR/ABL-positiveHealth Condition 2: C921- Chronic myeloid leukemia, BCR/ABL-positive
- Registration Number
- CTRI/2009/091/000204
- Lead Sponsor
- ATCO Pharma LimitedNATCO HouseRoad Banjara HillsHyderabad
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 41
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum Tolerated DoseTimepoint: 30 days
- Secondary Outcome Measures
Name Time Method Complete Hematological ResponseTimepoint: 30 Days