Ignite Creation Date:
2025-12-24 @ 5:22 PM
Ignite Modification Date:
2025-12-27 @ 12:20 AM
Study NCT ID:
NCT00089050
Status:
COMPLETED
Last Update Posted:
2011-11-30
First Post:
2004-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gemtuzumab Ozogamicin and Cyclosporine in Treating Older Patients With Relapsed Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D015479', 'term': 'Leukemia, Myelomonocytic, Acute'}, {'id': 'D007948', 'term': 'Leukemia, Monocytic, Acute'}, {'id': 'D004915', 'term': 'Leukemia, Erythroblastic, Acute'}, {'id': 'D007947', 'term': 'Leukemia, Megakaryoblastic, Acute'}, {'id': 'D015471', 'term': 'Leukemia, Basophilic, Acute'}, {'id': 'D015472', 'term': 'Leukemia, Eosinophilic, Acute'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D000079982', 'term': 'Gemtuzumab'}], 'ancestors': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'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': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-28', 'studyFirstSubmitDate': '2004-08-04', 'studyFirstSubmitQcDate': '2004-08-04', 'lastUpdatePostDateStruct': {'date': '2011-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-08-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy in terms of complete remission rate'}, {'measure': 'Toxicity'}, {'measure': 'Pharmacokinetics'}], 'secondaryOutcomes': [{'measure': 'Correlate clinical response to laboratory studies of drug susceptibility'}]}, 'conditionsModule': {'keywords': ['recurrent adult acute myeloid leukemia', 'adult acute minimally differentiated myeloid leukemia (M0)', 'adult acute myeloblastic leukemia without maturation (M1)', 'adult acute myeloblastic leukemia with maturation (M2)', 'adult acute myelomonocytic leukemia (M4)', 'adult acute monoblastic leukemia (M5a)', 'adult acute monocytic leukemia (M5b)', 'adult erythroleukemia (M6a)', 'adult pure erythroid leukemia (M6b)', 'adult acute megakaryoblastic leukemia (M7)', 'adult acute basophilic leukemia', 'adult acute eosinophilic leukemia', 'adult acute myeloid leukemia with 11q23 (MLL) abnormalities', 'adult acute myeloid leukemia with inv(16)(p13;q22)', 'adult acute myeloid leukemia with t(16;16)(p13;q22)', 'adult acute myeloid leukemia with t(8;21)(q22;q22)'], 'conditions': ['Leukemia']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Cyclosporine may increase the effectiveness of gemtuzumab ozogamicin by making cancer cells more sensitive to the drug. Combining gemtuzumab ozogamicin with cyclosporine may kill more cancer cells.\n\nPURPOSE: This phase II trial is studying how well giving gemtuzumab ozogamicin together with cyclosporine works in treating older patients with relapsed acute myeloid leukemia.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the efficacy of gemtuzumab ozogamicin and cyclosporine, in terms of the complete remission rate, in older patients with relapsed acute myeloid leukemia.\n* Determine the toxicity and pharmacokinetics of this regimen in these patients.\n\nSecondary\n\n* Correlate clinical response with laboratory studies of drug susceptibility in patients treated with this regimen.\n\nOUTLINE: Patients receive cyclosporine IV continuously over 72 hours on days 1-3 and 15-17. Eight hours after initiation of each cyclosporine infusion, patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed for survival.\n\nPROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Morphologically confirmed acute myeloid leukemia (AML) by bone marrow aspirate\n\n * More than 20% blasts by morphologic criteria\n * Relapsed disease ≥ 3 months after prior complete remission\n* Blasts CD33-positive by flow cytometry\n* No primary hematologic disorder that preceded initial presentation with AML\n* No documented secondary AML related to prior chemotherapy or toxin exposure\n* No acute promyelocytic leukemia (FAB M3)\n* Not a candidate for transplant therapy\n* No active CNS leukemia\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 60 and over\n\nPerformance status\n\n* Karnofsky 70-100%\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* WBC ≤ 30,000/mm\\^3 (hydroxyurea allowed)\n\nHepatic\n\n* Bilirubin ≤ 1.5 times upper limit of normal (ULN)\n* AST or ALT ≤ 1.5 times ULN\n\nRenal\n\n* Creatinine ≤ 1.5 mg/dL\n\nOther\n\n* HIV negative\n* No uncontrolled infection\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not planning hematopoietic stem cell transplantation immediately after study therapy\n\nChemotherapy\n\n* See Disease Characteristics\n* See Hematopoietic\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified\n\nOther\n\n* More than 1 month since prior investigational agents\n* No other concurrent anticancer therapy\n* No administration of any of the following for 24 hours after cyclosporine administration:\n\n * Diltiazem\n * Verapamil\n * Erythromycin\n * Clarithromycin\n * Metoclopramide\n * Phenytoin\n * Rifampin\n * Phenobarbital\n * Aminoglycosides\n * Amphotericin B\n * Vancomycin\n * Cimetidine\n * Ranitidine\n * Trimethoprim/sulfamethoxazole\n * Ketoconazole\n * Fluconazole\n * Itraconazole\n * Voriconazole\n * Carbamazepine'}, 'identificationModule': {'nctId': 'NCT00089050', 'briefTitle': 'Gemtuzumab Ozogamicin and Cyclosporine in Treating Older Patients With Relapsed Acute Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'A Phase II Trial Combining Gemtuzumab Ozogamicin (Mylotarg) With Cyclosporine for the Treatment of Relapsed Acute Myeloid Leukemia in Adults Over Age 60', 'orgStudyIdInfo': {'id': '1820.00'}, 'secondaryIdInfos': [{'id': 'FHCRC-1820.00'}, {'id': 'CDR0000378021', 'type': 'REGISTRY', 'domain': 'PDQ'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cyclosporine', 'type': 'DRUG'}, {'name': 'gemtuzumab ozogamicin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109-1024', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Stephen H. Petersdorf, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutchinson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}