Evaluation of the Therapeutic Effect of HU Pulse Therapy for CML Patients

• Status: Unknown status
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chronic-phase chronic myelogenous leukemia (CML) aimed to avoid CML conversion (AP, BC). Hydroxyurea pulse therapy for chronic-phase CML patients is effective based on the investigator's previous studies, and the scheme cost lower than imatinib. It is not yet known the efficacy compared Hydroxyurea pulse therapy with imatinib for chronic-phase CML, especially to achieve hematological remission in short time.

PURPOSE: Non-randomized trial to compare the effectiveness of hydroxyurea pulse therapy with that of imatinib in treating chronic-phase CML patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Harbin Medical University
• Treatments: Hydroxyurea; Imatinib Mesylate

Criteria

Inclusion Criteria:

1. Diagnosis of Chronic Myelogenous Leukemia (CML) in chronic phase. Patients in either accelerated or blastic phases are not eligible.

2. No previous therapy with any drugs.

3. Age ≥ 16 years

4. Patients with uncontrolled tachyarrhythmias (such as, atrial fibrillation, paroxysmal supraventricular tachycardia, and ventricular tachycardias not adequately controlled) are not eligible.

5. Non-pregnant and non-nursing. Treatment under this protocol would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective means of birth control.

Exclusion Criteria:

1. Patients treated with any chemotherapy drugs.

2. Patients younger than 16 years.