Clinical Trial of Imatinib with or without Hydroxyurea in patients of Leukaemia

Upfront Combined Hydroxyurea and Imatinib versus Imatinib Monotherapy in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia Patients with reference to Early Molecular response: A Randomized Controlled Study

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/08/020879

Enrollment

Registered

2019-08-26

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

Interventions

Intervention1: Hydroxyurea with Imatinib: Hydroxyurea rounded to nearest 500 mg dose (Standardised according to total leukocyte count) along with imatinib 400 mg once daily for 3 months Control Inter

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed patients of chronic phase chronic myeloid leukemia, age >= 18 years & of either sex, who are willing to provide consent.

Exclusion criteria

Exclusion criteria: 1. Patients with de novo accelerated phase or blast phase CML. 2. Patients who have already started either hydroxyurea or any tyrosine kinase inhibitor (TKI) treatment prior to randomization. 3. Pregnancy. 4. CML patients with active second malignancy.

Design outcomes

Primary

Measure	Time frame
1. To compare the early molecular response (EMR) rates (defined as BCR-ABL1 transcript level less than 10%, I.S.) at 3 months of treatment with Hydroxyurea and Imatinib combination and Imatinib monotherapy in newly diagnosed CML-CP patients. 2. To compare the adverse effects of the two treatment arms. Timepoint: 1. Every 2 weeks for 3 months	—

Secondary

Measure	Time frame
2. To compare the adverse effects of the two treatment armsTimepoint: Every 2 weeks for 3 months	—

Countries

India

Contacts

Public ContactRituparna chetia

All India Institute of Medical Sciences,Rishikesh

ritu4moon@gmail.com8800322804

Outcome results

None listed

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