Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT03515018
Status:
UNKNOWN
Last Update Posted:
2018-05-22
First Post:
2018-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Therapeutic Effect of HU Pulse Therapy for CML Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D015466', 'term': 'Leukemia, Myeloid, Chronic-Phase'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006918', 'term': 'Hydroxyurea'}, {'id': 'D000068877', 'term': 'Imatinib Mesylate'}], 'ancestors': [{'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-21', 'studyFirstSubmitDate': '2018-04-16', 'studyFirstSubmitQcDate': '2018-05-02', 'lastUpdatePostDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'white blood cell count', 'timeFrame': '2 years', 'description': 'white blood cell count decreased by 10%, 20%, 30%, 50%'}], 'secondaryOutcomes': [{'measure': 'spleen size', 'timeFrame': '2 years', 'description': 'spleen size reduced 10%, 20%, 30%, 50%'}, {'measure': 'complete remission', 'timeFrame': '2 years', 'description': 'the time to achieve complete remission'}, {'measure': 'long-term efficacy: OS, EFS, PFS', 'timeFrame': '5 years', 'description': 'OS, EFS, PFS'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Leukemia, Myeloid, Chronic-Phase', 'hydroxyurea', 'Imatinib Mesylate', 'Pulse Therapy, Drug'], 'conditions': ['Leukemia, Chronic Myeloid']}, 'referencesModule': {'references': [{'pmid': '28416739', 'type': 'BACKGROUND', 'citation': 'Valent P, Herndlhofer S, Schneeweiss M, Boidol B, Ringler A, Kubicek S, Gleixner KV, Hoermann G, Hadzijusufovic E, Mullauer L, Sperr WR, Superti-Furga G, Mannhalter C. TKI rotation-induced persistent deep molecular response in multi-resistant blast crisis of Ph+ CML. Oncotarget. 2017 Apr 4;8(14):23061-23072. doi: 10.18632/oncotarget.15481.'}, {'pmid': '27751981', 'type': 'BACKGROUND', 'citation': 'Huang J, Wang L, Chen L, Qun H, Yajing X, Fangping C, Xielan Z. Changing Treatment May Affect the Predictive Ability of European Treatment Outcome Study Scoring for the Prognosis of Patients with Chronic Myeloid Leukemia. Turk J Haematol. 2017 Mar 1;34(1):10-15. doi: 10.4274/tjh.2016.0156. Epub 2016 Oct 18.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nPURPOSE: Non-randomized trial to compare the effectiveness of hydroxyurea pulse therapy with that of imatinib in treating chronic-phase CML patients.", 'detailedDescription': '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.\n\nOUTLINE: 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.\n\nPROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of Chronic Myelogenous Leukemia (CML) in chronic phase. Patients in either accelerated or blastic phases are not eligible.\n2. No previous therapy with any drugs.\n3. Age ≥ 16 years\n4. Patients with uncontrolled tachyarrhythmias (such as, atrial fibrillation, paroxysmal supraventricular tachycardia, and ventricular tachycardias not adequately controlled) are not eligible.\n5. 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.\n\nExclusion Criteria:\n\n1. Patients treated with any chemotherapy drugs.\n2. Patients younger than 16 years.'}, 'identificationModule': {'nctId': 'NCT03515018', 'acronym': 'HU', 'briefTitle': 'Evaluation of the Therapeutic Effect of HU Pulse Therapy for CML Patients', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Harbin Medical University'}, 'officialTitle': 'Evaluation of the Therapeutic Effect of Hydroxyurea Pulse Therapy for Chronic Myeloid Leukemia Patients', 'orgStudyIdInfo': {'id': 'FirstAHHMU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydroxyurea', 'description': 'Drug: hydroxyurea, pulse therapy', 'interventionNames': ['Drug: hydroxyurea']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'imatinib', 'description': 'Drug: imatinib, 400mg PO per day', 'interventionNames': ['Drug: Imatinib']}], 'interventions': [{'name': 'hydroxyurea', 'type': 'DRUG', 'otherNames': ['HU'], 'description': 'pulse therapy', 'armGroupLabels': ['Hydroxyurea']}, {'name': 'Imatinib', 'type': 'DRUG', 'otherNames': ['Imatinib Mesylate'], 'description': '400mg qd PO per day', 'armGroupLabels': ['imatinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '150001', 'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jin Zhou, MD, PhD', 'role': 'CONTACT', 'email': 'zhoujin1111@126.com', 'phone': '008645185555951'}], 'facility': 'the First Affiliated Hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}], 'centralContacts': [{'name': 'Jin Zhou, MD, PhD', 'role': 'CONTACT', 'email': 'zhoujin1111@126.com', 'phone': '008645185555951'}], 'overallOfficials': [{'name': 'Jin Zhou, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital of Harbin Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}