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

Phase 3

• Conditions: Leukemia, Chronic Myeloid
• Interventions: Drug: hydroxyurea; Drug: Imatinib

• Registration Number: NCT03515018
• Lead Sponsor: First Affiliated Hospital of Harbin Medical University

Brief 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.

Detailed Description

OBJECTIVES: I. Compare the time of WBC decreased by 10%,20%,30%,50% of these patients treated with these two drugs. II. Compare the time of spleen size decreased by 10%,20%,30%,50% of chronic-phase chronic myelogenous leukemia patients treated with imatinib to those treated with hydroxyurea pulse therapy. III. Compare the time to achieve complete remission (CR) of these patients treated with these two drugs. iv. Estimate the overall survival, event-free survival, progression-free survival (OS, EFS, PFS) and major cytogenetic response of these patients treated with these two drugs.

OUTLINE: Patients are to receive one of two treatments. Arm I: Induction: Patients receive oral hydroxyurea daily (hydroxyurea pulse therapy) until hematological remission. Maintenance: continuing hydroxyurea pulse therapy to maintain white blood cells below 8. 0 × 109 / L. Arm II: Induction: Patients receive imatinib 400mg qd until acceptable blood counts are achieved. Maintenance: Follow the recommendations of the NCCN guidelines for chronic-phase CML treatment.

PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 2 years.

Study Timeline

• Status Verified: 2017-12
• Study First Submitted: 2018-04-16
• Study Start: 2018-05-01
• Study First Submitted QC: 2018-05-02
• Study First Posted: 2018-05-03
• Last Update Submitted: 2018-05-21
• Last Update Posted: 2018-05-22
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydroxyurea	hydroxyurea	Drug: hydroxyurea, pulse therapy
imatinib	Imatinib	Drug: imatinib, 400mg PO per day

Primary Outcome Measures

Name	Time	Method
white blood cell count	2 years	white blood cell count decreased by 10%, 20%, 30%, 50%

Secondary Outcome Measures

Name	Time	Method
spleen size	2 years	spleen size reduced 10%, 20%, 30%, 50%
long-term efficacy: OS, EFS, PFS	5 years	OS, EFS, PFS
complete remission	2 years	the time to achieve complete remission

Trial Locations

Locations (1)

the First Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China