Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-27 @ 9:58 PM
Study NCT ID:
NCT01409161
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2011-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015473', 'term': 'Leukemia, Promyelocytic, Acute'}], 'ancestors': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'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': 'D000077237', 'term': 'Arsenic Trioxide'}, {'id': 'C032793', 'term': 'arsenous acid'}, {'id': 'D000079982', 'term': 'Gemtuzumab'}, {'id': 'D014212', 'term': 'Tretinoin'}], 'ancestors': [{'id': 'D001152', 'term': 'Arsenicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D000080084', 'term': 'Calicheamicins'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D014801', 'term': 'Vitamin A'}, {'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 151}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2011-08-02', 'studyFirstSubmitQcDate': '2011-08-02', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event free survival', 'timeFrame': 'The time from the start of treatment to first documentation of disease relapse or death, assessed up to 2 years', 'description': 'Monitored using a Bayesian time-to-event model.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Promyelocytic Leukemia With PML-RARA']}, 'referencesModule': {'references': [{'pmid': '39584789', 'type': 'DERIVED', 'citation': 'Jen WY, Marvin-Peek J, Kantarjian HM, Alvarado Y, Borthakur G, Jabbour E, Wierda W, Kadia TM, Daver NG, DiNardo CD, Short NJ, Jain N, Ferrajoli A, Kornblau S, Yilmaz M, Ohanian M, McCue D, Burger J, Hammond D, Patel K, Issa GC, Pemmaraju N, Sasaki K, Maiti A, Abbas HA, Chien K, Takahashi K, Haddad F, Bose P, Masarova L, Montalban-Bravo G, Swaminathan M, Brandt M, Pierce S, Garcia-Manero G, Ravandi F. Long-term follow-up of a phase 2 study of all-trans retinoic acid, arsenic trioxide, and gemtuzumab ozogamicin in acute promyelocytic leukemia. Cancer. 2025 Jan 1;131(1):e35662. doi: 10.1002/cncr.35662. Epub 2024 Nov 25.'}], 'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'M D Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'This phase II trial studies how well tretinoin and arsenic trioxide with or without gemtuzumab ozogamicin works in treating patients with previously untreated acute promyelocytic leukemia. Drugs used in chemotherapy, such as tretinoin and arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotoxins, such as gemtuzumab ozogamicin, may find certain cancer cells and kill them without harming normal cells. Giving tretinoin and arsenic trioxide together with gemtuzumab ozogamicin may kill more cancer cells.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Assess whether a combination of all-trans retinoic acid (ATRA \\[tretinoin\\]), and arsenic trioxide (ATO) can produce long-term event-free survival in patients with low-risk untreated acute promyelocytic leukemia (APL).\n\nII. Assess whether administration of gemtuzumab ozogamicin (GO) at the diagnosis in patients with high-risk APL (white blood cell \\[WBC\\] \\> 10,000) and if the WBC rises to \\> 10,000 after start of treatment (in patients with low-risk disease) will improve complete response (CR) rate without increasing toxicity in high-risk untreated APL.\n\nOUTLINE:\n\nINDUCTION: Patients receive tretinoin orally (PO) twice daily (BID), arsenic trioxide intravenously (IV) over 1-2 hours daily, and gemtuzumab ozogamicin IV over 2 hours once at weeks 1-4.\n\nCONSOLIDATION: Patients achieving CR receive arsenic trioxide IV 5 days per week during weeks 1-4, 9-12, 17-20, and 25-28 and tretinoin PO BID for 2 weeks on and 2 weeks off. Treatment repeats every 8 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up every 6-12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A diagnosis of APL based on the presence of the PML-RAR-alpha fusion gene by cytogenetics, polymerase chain reaction (PCR), or POD test\n* Ability to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigational nature of the study\n* Patients in whom therapy for APL was initiated on an emergent basis are eligible (patients may have already started treatment with ATRA, ATO, and/or one dose of idarubicin due to the urgency to start therapy early)\n* Women of child-bearing potential must have a negative serum pregnancy test at screening; in addition to having a negative pregnancy test confirmed at screening, all female participants of childbearing potential must have a negative pregnancy test confirmed within 48 hours prior to dosing with the study drug\n* All sexually active subjects (males and females of child-bearing potential) agree to use 2 effective methods of contraception for the duration of the study\n\nExclusion Criteria:\n\n* Fridericia corrected QT (QTcF) interval on the electrocardiogram (EKG) greater than 480 milliseconds\n* Patients with creatinine \\> 2.5 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease\n* Patients with total bilirubin \\>= 2.0 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease\n* Patients with alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \\> 3 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease"}, 'identificationModule': {'nctId': 'NCT01409161', 'briefTitle': 'Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Phase II Study of Treatment of Acute Promyelocytic Leukemia (APL) With ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin (GO)', 'orgStudyIdInfo': {'id': '2010-0981'}, 'secondaryIdInfos': [{'id': 'NCI-2011-02767', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2010-0981', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (tretinoin, arsenic trioxide, gemtuzumab ozogamicin)', 'description': 'INDUCTION: Patients receive tretinoin PO BID, arsenic trioxide IV over 1-2 hours daily, and gemtuzumab ozogamicin IV over 2 hours once at weeks 1-4.\n\nCONSOLIDATION: Patients achieving CR receive arsenic trioxide IV 5 days per week during weeks 1-4, 9-12, 17-20, and 25-28 and tretinoin PO BID for 2 weeks on and 2 weeks off. Treatment repeats every 8 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Arsenic Trioxide', 'Drug: Gemtuzumab Ozogamicin', 'Other: Laboratory Biomarker Analysis', 'Drug: Tretinoin']}], 'interventions': [{'name': 'Arsenic Trioxide', 'type': 'DRUG', 'otherNames': ['Arsenic (III) Oxide', 'Arsenic Sesquioxide', 'Arsenous Acid', 'Arsenous Acid Anhydride', 'Arsenous Oxide', 'Trisenox', 'White Arsenic'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (tretinoin, arsenic trioxide, gemtuzumab ozogamicin)']}, {'name': 'Gemtuzumab Ozogamicin', 'type': 'DRUG', 'otherNames': ['Calicheamicin-Conjugated Humanized Anti-CD33 Monoclonal Antibody', 'CDP-771', 'CMA-676', 'gemtuzumab', 'hP67.6-Calicheamicin', 'Mylotarg', 'WAY-CMA-676'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (tretinoin, arsenic trioxide, gemtuzumab ozogamicin)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (tretinoin, arsenic trioxide, gemtuzumab ozogamicin)']}, {'name': 'Tretinoin', 'type': 'DRUG', 'otherNames': ['2,4,6,8-Nonatetraenoic acid, 3, 7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-, (all-E)-', 'Aberel', 'Airol', 'Aknoten', 'all trans-Retinoic acid', 'All-trans Retinoic Acid', 'All-trans Vitamin A Acid', 'all-trans-Retinoic acid', 'all-trans-Vitamin A acid', 'ATRA', 'Avita', 'beta-Retinoic Acid', 'Cordes Vas', 'Dermairol', 'Epi-Aberel', 'Eudyna', 'Renova', 'Retin-A', 'Retin-A MICRO', 'Retin-A-Micro', 'retinoic acid', 'Retisol-A', 'Ro 5488', 'Stieva-A', 'Stieva-A Forte', 'Trans Retinoic Acid', 'Trans Vitamin A Acid', 'trans-Retinoic acid', 'Tretinoinum', 'Vesanoid', 'vitamin A acid', 'Vitamin A acid, all-trans-', 'Vitinoin'], 'description': 'Given PO', 'armGroupLabels': ['Treatment (tretinoin, arsenic trioxide, gemtuzumab ozogamicin)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Farhad Ravandi-Kashani', 'role': 'CONTACT', 'phone': '713-745-0394'}, {'name': 'Farhad Ravandi-Kashani', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77094', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Farhad Ravandi-Kashani', 'role': 'CONTACT', 'phone': '713-745-0394'}, {'name': 'Farhad Ravandi-Kashani', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MD Anderson Regional Care Center-Katy', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77058', 'city': 'Nassau Bay', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Farhad Ravandi-Kashani', 'role': 'CONTACT', 'phone': '713-745-0394'}, {'name': 'Farhad Ravandi-Kashani', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MD Anderson Regional Care Center-Bay Area', 'geoPoint': {'lat': 29.54468, 'lon': -95.09104}}, {'zip': '77478', 'city': 'Sugar Land', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Farhad Ravandi-Kashani', 'role': 'CONTACT', 'phone': '713-745-0394'}, {'name': 'Farhad Ravandi-Kashani', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MD Anderson Regional Care Center-Sugar Land', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}, {'zip': '77384', 'city': 'The Woodlands', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Farhad Ravandi-Kashani', 'role': 'CONTACT', 'phone': '713-745-0394'}, {'name': 'Farhad Ravandi-Kashani', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MD Anderson Regional Care Center-The Woodlands', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}], 'centralContacts': [{'name': 'Farhad Ravandi-Kashani', 'role': 'CONTACT', 'email': 'fravandi@mdanderson.org', 'phone': '713-745-0394'}], 'overallOfficials': [{'name': 'Farhad Ravandi-Kashani', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}