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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Therapeutic Effect of Hydroxyurea Pulse Therapy for Chronic Myeloid Leukemia Patients

Conditions
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Leukemia, Chronic Myeloid

Intervention / Treatment
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* Drug: hydroxyurea
* Drug: Imatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Chronic Myelogenous Leukemia (CML) in chronic phase. Patients in either accelerated or blastic phases are not eligible. No previous therapy with any drugs. Age ≥ 16 years Patients with uncontrolled tachyarrhythmias (such as, atrial fibrillation, paroxysmal supraventricular tachycardia, and ventricular tachycardias not adequately controlled) are not eligible. 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: Patients treated with any chemotherapy drugs. Patients younger than 16 years.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydroxyurea<br>Drug: hydroxyurea, pulse therapy | Drug: hydroxyurea<br>* pulse therapy<br>* Other names: HU;|
| Active Comparator: imatinib<br>Drug: imatinib, 400mg PO per day | Drug: Imatinib<br>* 400mg qd PO per day<br>* Other names: Imatinib Mesylate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| white blood cell count | white blood cell count decreased by 10%, 20%, 30%, 50% | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spleen size | spleen size reduced 10%, 20%, 30%, 50% | 2 years | 
| complete remission | the time to achieve complete remission | 2 years | 
| long-term efficacy: OS, EFS, PFS | OS, EFS, PFS | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leukemia, Myeloid, Chronic-Phase, hydroxyurea, Imatinib Mesylate, Pulse Therapy, Drug