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

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ClinicalTrials.gov Identifier: NCT03515018
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Leukemia, Chronic Myeloid Drug: hydroxyurea Drug: Imatinib Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Hydroxyurea
Drug: hydroxyurea, pulse therapy
Drug: hydroxyurea
pulse therapy
Other Name: HU

Active Comparator: imatinib
Drug: imatinib, 400mg PO per day
Drug: Imatinib
400mg qd PO per day
Other Name: Imatinib Mesylate




Primary Outcome Measures :
  1. white blood cell count [ Time Frame: 2 years ]
    white blood cell count decreased by 10%, 20%, 30%, 50%


Secondary Outcome Measures :
  1. spleen size [ Time Frame: 2 years ]
    spleen size reduced 10%, 20%, 30%, 50%

  2. complete remission [ Time Frame: 2 years ]
    the time to achieve complete remission

  3. long-term efficacy: OS, EFS, PFS [ Time Frame: 5 years ]
    OS, EFS, PFS



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Jin Zhou, MD, PhD 008645185555951 zhoujin1111@126.com

Locations
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China, Heilongjiang
the First Affiliated Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150001
Contact: Jin Zhou, MD, PhD    008645185555951    zhoujin1111@126.com   
Sponsors and Collaborators
First Affiliated Hospital of Harbin Medical University
Investigators
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Study Chair: Jin Zhou, MD, PhD First Affiliated Hospital of Harbin Medical University

Publications:
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Responsible Party: First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT03515018     History of Changes
Other Study ID Numbers: FirstAHHMU
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by First Affiliated Hospital of Harbin Medical University:
Leukemia, Myeloid, Chronic-Phase
hydroxyurea
Imatinib Mesylate
Pulse Therapy, Drug
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Hydroxyurea
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antisickling Agents
Nucleic Acid Synthesis Inhibitors