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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000204

Enrollment

Registered

2009-08-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C921- Chronic myeloid leukemia, BCR/ABL-positive Health Condition 2: C921- Chronic myeloid leukemia, BCR/ABL-positive

Interventions

Intervention1: NRC-AN-019: Starting with 200 mg per day for 30 days and continuation in Escalating doses as the Trial progresses Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Secondary

Measure	Time frame
Complete Hematological ResponseTimepoint: 30 Days	—

Primary

Measure	Time frame
Maximum Tolerated DoseTimepoint: 30 days	—

Countries

India

Contacts

Public ContactDrGVenkat Ramana

Sponsor

pcmyneni@yahoo.com04023547532

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026