Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-29 @ 11:34 AM
Study NCT ID:
NCT03053206
Status:
UNKNOWN
Last Update Posted:
2017-02-15
First Post:
2017-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Interventional Study Assessing Response to Cytarabine, Daunorubicin and Etoposide (ADE) for First Relapse of Paediatric Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C060154', 'term': 'DAV regimen'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-10', 'studyFirstSubmitDate': '2017-02-07', 'studyFirstSubmitQcDate': '2017-02-10', 'lastUpdatePostDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete remission (CR) rate', 'timeFrame': 'Day 28 ± 7 of treatment or after recovery of blood counts whichever is earlier', 'description': 'To assess the complete remission (CR) rate with the use of ADE chemotherapy in relapsed acute myeloid leukemia (AML) after first CR'}], 'secondaryOutcomes': [{'measure': 'Event free survival (EFS) and overall survival(OS)', 'timeFrame': '2 year', 'description': 'To determineevent free survival(EFS) and overall survival(OS)'}, {'measure': 'toxicity of chemotherapy', 'timeFrame': 'Day 28 ± 7 of treatment', 'description': 'To assess the toxicity of chemotherapy using CTCAE 4.0'}, {'measure': 'clonal evolution', 'timeFrame': 'Day 28 ± 7 of treatment', 'description': 'To evaluate clonal evolution using cytogenetics \\&RT-PCR panel'}, {'measure': 'minimal residual disease (MRD)', 'timeFrame': 'Day 28 ± 7 of treatment or after recovery of blood counts whichever is earlier', 'description': 'To assess minimal residual disease (MRD) by using flow cytometry'}, {'measure': 'cardiac function', 'timeFrame': 'Day 28 ± 7 of treatment', 'description': 'To evaluate cardiac function using 2 Dimensional Echocardiography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia, in Relapse']}, 'descriptionModule': {'briefSummary': 'One-third to one-half of patients with AML relapse and in general relapsed AML patients have a poor prognosis. The treatment of relapsed AML consists of induction chemotherapy followed by Allogenic Stem Cell Transplant (ASCT). However, at present there is no standard salvage chemotherapy regimen for relapsed AML, as no study has shown any one regimen to be significantly superior. Anthracyclines, Fludarabine, Etoposide and cytarabineare active agents in AMLand have been used as monotherapy and in combination in refractory and relapsed AML patients. According to previous studies the present CR rate of different regimens ranges from 50-70%. A retrospective analysis (unpublished) conducted at IRCH, AIIMS on relapsed AML patients treated with ADE (Cytarabine, Daunorubicin and Etoposide) chemotherapy showed the CR rates of approximately 70%. Therefore, we have planned this study to test the efficacy and toxicity of ADE induction chemotherapy in relapsed AML patients in a prospective manner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Either gender with age ≤18 years at initial diagnosis\n2. AML(non-M3) patients at first relapse (medullary)\n\nExclusion Criteria:\n\n1. Primary refractory AML \\&secondary AML\n2. More than or equal to 2 relapses of AML\n3. Symptomatic cardiac dysfunction (CTCAE Grade 3 or 4)\n4. Active infection(pneumonia etc.)\n5. Any other organ dysfunction (CTCAE Grade 4)\n6. Patients not willing to consent for the study'}, 'identificationModule': {'nctId': 'NCT03053206', 'briefTitle': 'A Prospective, Interventional Study Assessing Response to Cytarabine, Daunorubicin and Etoposide (ADE) for First Relapse of Paediatric Acute Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'All India Institute of Medical Sciences'}, 'officialTitle': 'RESPONSE TO CYTARABINE, DAUNORUBICIN AND ETOPOSIDE (ADE) AT FIRST RELASPE IN CHILDHOOD AML', 'orgStudyIdInfo': {'id': 'IECPG-660/22.12.2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADE arm', 'description': 'ADE arm\n\nCytarabine (100mg/m2 d1-d10 BD), Daunorubicin (50mg/m2 d1-d3) and Etoposide (100 mg/m2 d1-5) over a period of 10 days', 'interventionNames': ['Drug: ADE Protocol']}], 'interventions': [{'name': 'ADE Protocol', 'type': 'DRUG', 'description': 'ADE chemotherapy\n\nCytarabine (100mg/m2 d1-d10 BD), Daunorubicin (50mg/m2 d1-d3) and Etoposide (100 mg/m2 d1-5) over a period of 10 days', 'armGroupLabels': ['ADE arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ARUN GARG, DM', 'role': 'CONTACT', 'email': 'arungarg_aiims@yahoo.com', 'phone': '9968588792'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'All India Institute of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'SENIOR RESIDENT', 'investigatorFullName': 'ARUN GARG, MD, DM', 'investigatorAffiliation': 'All India Institute of Medical Sciences'}}}}