Evaluation of the Therapeutic Effect of HU Pulse Therapy for CML Patients (HU)
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|ClinicalTrials.gov Identifier: NCT03515018|
Recruitment Status : Unknown
Verified December 2017 by First Affiliated Hospital of Harbin Medical University.
Recruitment status was: Recruiting
First Posted : May 3, 2018
Last Update Posted : May 22, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Chronic Myeloid||Drug: hydroxyurea Drug: Imatinib||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Therapeutic Effect of Hydroxyurea Pulse Therapy for Chronic Myeloid Leukemia Patients|
|Actual Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||May 1, 2020|
Drug: hydroxyurea, pulse therapy
Other Name: HU
Active Comparator: imatinib
Drug: imatinib, 400mg PO per day
400mg qd PO per day
Other Name: Imatinib Mesylate
- white blood cell count [ Time Frame: 2 years ]white blood cell count decreased by 10%, 20%, 30%, 50%
- spleen size [ Time Frame: 2 years ]spleen size reduced 10%, 20%, 30%, 50%
- complete remission [ Time Frame: 2 years ]the time to achieve complete remission
- long-term efficacy: OS, EFS, PFS [ Time Frame: 5 years ]OS, EFS, PFS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515018
|Contact: Jin Zhou, MD, PhDemail@example.com|
|the First Affiliated Hospital of Harbin Medical University||Recruiting|
|Harbin, Heilongjiang, China, 150001|
|Contact: Jin Zhou, MD, PhD 008645185555951 firstname.lastname@example.org|
|Study Chair:||Jin Zhou, MD, PhD||First Affiliated Hospital of Harbin Medical University|