Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 11:38 PM
Study NCT ID:
NCT03419494
Status:
UNKNOWN
Last Update Posted:
2018-02-05
First Post:
2018-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Liposomal Doxorubicin and Daunorubicin-containing VDCLD Regimen in the Treatment of Adult ALL Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C041277', 'term': '1-dodecylpyridoxal'}, {'id': 'C506643', 'term': 'liposomal doxorubicin'}, {'id': 'D003630', 'term': 'Daunorubicin'}], 'ancestors': [{'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-26', 'studyFirstSubmitDate': '2018-01-11', 'studyFirstSubmitQcDate': '2018-01-26', 'lastUpdatePostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CR', 'timeFrame': 'From date of randomization until the date of first course of chemotherapy treatment completed, assessed up to 4 weeks.', 'description': 'complete remission after the first course treatment of induced remission chemotherapy'}], 'secondaryOutcomes': [{'measure': 'changes of myeloid leukemia stem cells', 'timeFrame': 'From date of randomization until the date of first course of chemotherapy treatment completed, assessed up to 4 weeks.', 'description': 'to evaluate the changes of myeloid leukemia stem cells in patients before and after induction of VDCLD with PLD and DNR respectively.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adult Acute Lymphoblastic Leukemia']}, 'descriptionModule': {'briefSummary': 'This trial is a multicenter prospective, open, non-intervention clinical study. 200 patients with newly diagnosed adult ALL who underwent induction remission with the VDCLD regimen containing PLD and DNR, respectively,were plan to enrolled in this study to evaluate the CR rate and the level of myeloid leukemia stem cells in the first course of chemotherapy with two regimens; and to evaluate the safety of the two induction chemotherapy regimens.', 'detailedDescription': 'Subjects will receive one of two treatment regimens:\n\nGroup A: intravenous drip of liposomal doxorubicin 36 mg/m2, d1、d15，1h； VCR 1.4mg/m2.d d1，d8，d15，d22 iv，CTX 800mg/m2.d d1 ivdrip，L-asp 6000u/m2.d d19～28 ivdrip，Dex10mg.d d1～28 ivdrip，once every 28days.\n\nGroup B: intravenous drip of DNR45mg/m2，d d1～3，1h；VCR 1.4mg/m2.d d1，d8，d15，d22 iv，CTX 800mg/m2.d d1 ivdrip，L-asp 6000u/m2.d d19～28 ivdrip，Dex10mg.d d1～28 ivdrip，once every 28days. The primary endpoint is complete remission after the first course treatment of induced remission chemotherapy, to evaluated the ratio of CR patients after the first course of chemotherapy with PLD and DNR VDCLD regimens.The secondary endpoint is to evaluate the changes of myeloid leukemia stem cells in patients before and after induction of VDCLD with PLD and DNR respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '14 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This clinical trial will evaluate patients with primary adult ALL who meet the aboving inclusion and exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.Male or female, age:14-60 years old; 2.ECOG score 0-2; 3.Subjects had confirmed ALL (WHO classification, primitive cells ≥ 20%); 4.Patients with newly diagnosed ALL who have not previously received chemotherapy (except for dexamethasone, prednisone, hydroxyurea).Blood transfusion, use of hematopoietic growth factors or vitamins are allowed. Some temporary measures such as leukocyte removal, dexamethasone, prednisone, hydroxyurea (0.5-3g daily, over 3 days) are allowed; 5.Flow cytometry was used to detect leukemic stem cells in bone marrow samples before treatment; 6.Informed consent (all studies must be signed patient informed consent).\n\nExclusion Criteria:\n\n* 1.Mixed AL patients; 2.Active systemic infection; 3.Lactating women, fertile women with positive pregnancy tests for urine or pregnant women who are unwilling to adopt appropriate methods of contraception (such as the use of birth control pills, intrauterine devices, diaphragms, abstinence, condom use) during the study ; 4. Patients currently have a history of cardiac insufficiency (especially congestive heart failure) or previous history of congestive heart failure; 5. Patients with severe liver failure (≥5 times upper limit of normal transaminase, total bilirubin ≥3 mg/dL); 6. Patients had renal insufficiency with creatinine clearance \\<30 ml/min and creatinine clearance calculated as follows: Male: Ccr (ml / min) = (140-age) × body weight (kg) / \\[0.8136 × serum creatinine (μmol/L)\\] women: Ccr (ml/min) = (140-age) × body weight (kg) × 0.85 / \\[0.8136 × serum creatinine (μmol/L)\\]; 7. Patient is involved in other drugs experimental study within 30 days prior to the trial or within 90 days of the start of the trial; 8. Researchers think it is not suitable for enrolling.'}, 'identificationModule': {'nctId': 'NCT03419494', 'briefTitle': 'Comparison of Liposomal Doxorubicin and Daunorubicin-containing VDCLD Regimen in the Treatment of Adult ALL Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSPC ZhongQi Pharmaceutical Technology Co., Ltd.'}, 'officialTitle': 'Comparison of Remission Rate and Leukemic Stem Cell Changes Among Patients With Newly Diagnosed Adult ALL With Liposomal Doxorubicin and Daunorubicin-containing VDCLD Regimen.', 'orgStudyIdInfo': {'id': '2013ALL-PLD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VDCLD regimen containing PLD', 'description': 'PLD 36mg/㎡.d d1、d15，ivdrip，1h，VCR 1.4mg/㎡.d d1，d8，d15，d22 iv，CTX 800mg/㎡.d d1 ivdrip，L-asp 6000u/㎡.d d19～28 ivdrip，Dex10mg.d d1～28 ivdrip', 'interventionNames': ['Drug: PLD']}, {'label': 'VDCLD regimen containing DNR', 'description': 'DNR 45mg/㎡.d d1～3，ivdrip，1h，VCR 1.4mg/㎡.d d1，d8，d15，d22 iv，CTX 800mg/㎡.d d1 ivdrip，L-asp 6000u/㎡.d d19～28 ivdrip，Dex10mg.d d1～28 ivdrip', 'interventionNames': ['Drug: DNR']}], 'interventions': [{'name': 'PLD', 'type': 'DRUG', 'otherNames': ['pegylated liposomal doxorubicin'], 'description': 'PLD36mg/m2.d d1、d15，ivdrip，1h，VCR 1.4mg/m2.d d1，d8，d15，d22 iv，CTX 800mg/m2.d d1 ivdrip，L-asp 6000u/m2.d d19～28 ivdrip，Dex10mg.d d1～28 ivdrip', 'armGroupLabels': ['VDCLD regimen containing PLD']}, {'name': 'DNR', 'type': 'DRUG', 'otherNames': ['Daunorubicin'], 'description': 'DNR 45mg/m2.d d1～3，ivdrip，1h，VCR 1.4mg/m2.d d1，d8，d15，d22 iv，CTX 800mg/m2.d d1 ivdrip，L-asp 6000u/m2.d d19～28 ivdrip，Dex10mg.d d1～28 ivdrip', 'armGroupLabels': ['VDCLD regimen containing DNR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '524001', 'city': 'Guangdong', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'honghua he, doctor', 'role': 'CONTACT', 'email': '192880@qq.com', 'phone': '13828229695'}], 'facility': 'Affiliated Hospital of Guangdong Medical University'}], 'centralContacts': [{'name': 'jiandong nie, doctor', 'role': 'CONTACT', 'email': 'niejd@mail.ecspc.com', 'phone': '0311-66575708'}], 'overallOfficials': [{'name': 'zhigang yang, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Hospital of Guangdong Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSPC ZhongQi Pharmaceutical Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}