Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-27 @ 6:17 AM
Study NCT ID:
NCT00822094
Status:
COMPLETED
Last Update Posted:
2017-11-24
First Post:
2009-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of CPX-351 in Adult Patients With First Relapse Acute Myeloid Leukemia (AML)
Sponsor:
Organization:
Raw JSON
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'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)', 'description': 'Safety Population: All randomized participants who received at least one dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'CPX-351', 'description': 'First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion', 'otherNumAtRisk': 81, 'otherNumAffected': 81, 'seriousNumAtRisk': 81, 'seriousNumAffected': 53}, {'id': 'EG001', 'title': 'Salvage Therapy', 'description': "First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice", 'otherNumAtRisk': 44, 'otherNumAffected': 44, 'seriousNumAtRisk': 44, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 7}], 'organSystem': 'Cardiac disorders'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Mouth Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Oral Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 9}], 'organSystem': 'General disorders'}, {'term': 'Catheter Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 4}], 'organSystem': 'General disorders'}, {'term': 'Catheter Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 10}], 'organSystem': 'General disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 16}], 'organSystem': 'General disorders'}, {'term': 'Mucosal Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 9}], 'organSystem': 'General disorders'}, {'term': 'Oedema 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'numAtRisk': 81, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 4}], 'organSystem': 'Infections and infestations'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 4}], 'organSystem': 'Infections and infestations'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Infections and infestations'}, {'term': 'Allergic Transfusion Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Procedural Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural 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'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypnoatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 14}, {'groupId': 'EG001', 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'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Night Sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG001', 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[{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Bone Marrow Necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 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'classes': [{'categories': [{'measurements': [{'value': '49.4', 'spread': '11.57', 'groupId': 'BG000'}, {'value': '51.8', 'spread': '11.54', 'groupId': 'BG001'}, {'value': '50.2', 'spread': '11.57', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set\n\nOne subject in the Salvage Therapy arm was randomized and withdrew consent prior to treatment, and therefore was excluded from the analysis'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'dispFirstSubmitDate': '2013-02-20', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-20', 'studyFirstSubmitDate': '2009-01-12', 'dispFirstSubmitQcDate': '2013-02-20', 'resultsFirstSubmitDate': '2017-09-03', 'studyFirstSubmitQcDate': '2009-01-13', 'dispFirstPostDateStruct': {'date': '2013-02-22', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-09-03', 'studyFirstPostDateStruct': {'date': '2009-01-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Subjects Surviving at 1 Year', 'timeFrame': 'Up to 1 year from randomization', 'description': 'The proportion of subjects surviving at 1 year was evaluated separately for each arm by the number of subjects alive at 1 year divided by the total number of subjects.'}], 'secondaryOutcomes': [{'measure': 'Complete Remission Rate', 'timeFrame': 'Following 1st induction, following 2nd induction if applicable'}, {'measure': 'Event Free Survival', 'timeFrame': 'Up to 1 year from randomization', 'description': 'Progression EFS median'}, {'measure': 'Remission Duration', 'timeFrame': 'Following achievement of CR and up to 1 year from randomization', 'description': 'Remission duration was measured from the time the criteria for CR were first met until the first date that disease relapse was objectively documented or until subject death.'}, {'measure': 'Rate of Aplasia', 'timeFrame': 'Up to 1 year from randomization', 'description': 'Patients with Aplasia During Study'}, {'measure': 'Rate of Stem Cell Transplant', 'timeFrame': 'Up to 1 year from randomization', 'description': 'Number of patients transferred for stem cell transplant'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute', 'Myeloid', 'Leukemia', 'Adult', 'First', 'Relapse', 'AML', 'Acute Myelogenous leukemia', 'Leukemia, Myeloid', 'Leukemia, Myeloid, Acute', 'Acute myelocytic leukemia'], 'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'The study investigates if CPX-351 will be a) more effective than the standard intensive salvage AML treatment and b) more tolerable than the standard intensive salvage treatment regimens.\n\nThe study compares the investigational product CPX-351 vs the standard intensive salvage treatment for first relapse AML patients.', 'detailedDescription': 'This study is a randomized, open-label, parallel-arm, fixed-dose, standard therapy controlled Phase IIB trial. Study enrollment duration is expected to be approximately 12-18 months. On entry, patients are randomized to receive either CPX-351 or intensive first salvage treatment.\n\nPatients are stratified to balance the likelihood of obtaining a CR and the duration of CR between the two arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ability to understand and voluntarily sign an informed consent form\n* Age ≥18 and ≤65 years at the time of relapse\n* Pathological confirmation of relapsed AML after initial CR of \\>1 month duration\n* Eastern Cooperative Oncology Group (ECOG) performance status 0- 2\n* Able to adhere to the study visit schedule and other protocol requirements\n* Laboratory values fulfilling the following:\n\n * Serum creatinine \\< 2.0 mg/dL\n * Serum total bilirubin \\< 2.0 mg/dL\n * Serum alanine aminotransferase or aspartate aminotransferase \\<3xULN Note: If elevated liver enzymes are related to disease; contact medical monitor to discuss.\n* Cardiac ejection fraction \\> 50% by echocardiography or MUGA scan\n* All men and women must agree to practice effective contraception during the study period and for 3 months afterward if not otherwise documented to be infertile.\n\nExclusion Criteria:\n\n* Patients with active second malignancies are excluded. Patients with second malignancies in remission may be eligible if there is no clinical evidence of active disease, documented by imaging, with tumor marker studies, etc., at screening. Patients maintained on long-term non-chemotherapy treatment, e.g., hormonal therapy, are eligible. In all cases, the second malignancy and its non-chemotherapy treatment must not interfere with the investigators ability to assess the safety or efficacy of the study treatment\n* Patients with acute promyelocytic leukemia \\[t(15;17)\\]\n* Total lifetime anthracycline exposure exceeding the equivalent of 368 mg/m2 of daunorubicin (or equivalent) prior to start of study therapy\n* Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent\n* Administration of any antineoplastic therapy within 4 weeks of therapy; intended to treat first relapse. In the event of rapidly proliferative disease use of hydroxyurea is permitted until 24 hours before the start of study treatment\n* Clinical evidence of active CNS leukemia\n* Patients with history of and/or current evidence of myocardial impairment (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in New York Heart Association Class III or IV staging\n* Active and uncontrolled infection. Patients with a bacterial infection receiving treatment with antibiotics may be entered into the study if they are afebrile and hemodynamically stable for \\>72 hrs.\n* Current evidence of invasive fungal infection (blood or tissue culture); active hepatitis C infection or known HIV infection\n* Hypersensitivity to cytarabine, daunorubicin or liposomal products\n* History of Wilson's disease or other copper-related disorder\n* Patients with a history of severe toxicity related to receiving conventional dose cytarabine in first line treatment (approximately 100mg/m2/d for \\<7 days) are excluded. Patients who experienced unacceptable toxicities while receiving high dose cytarabine (approximately 3000mg/m2 for 6 doses) will not be treated again with the same regimen, but could be randomized to treatment with conventional dose cytarabine regimens where the risk of major toxicity is less.\n* Woman who are pregnant or breast feeding"}, 'identificationModule': {'nctId': 'NCT00822094', 'briefTitle': 'Trial of CPX-351 in Adult Patients With First Relapse Acute Myeloid Leukemia (AML)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jazz Pharmaceuticals'}, 'officialTitle': 'Phase IIB, Multicenter, Randomized, Open-Label Trial Of CPX-351 (Cytarabine : Daunorubicin) Liposome Injection Versus Intensive Salvage Therapy In Adult Patients ≤ 65 Years Old With AML In First Relapse Following An Initial CR > 1 Month Duration', 'orgStudyIdInfo': {'id': 'CLTR0308-205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPX-351 (Arm A)', 'description': 'First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion', 'interventionNames': ['Drug: CPX-351']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Salvage Therapy (Arm B)', 'description': "First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice", 'interventionNames': ['Drug: Intensive Salvage Therapy']}], 'interventions': [{'name': 'CPX-351', 'type': 'DRUG', 'armGroupLabels': ['CPX-351 (Arm A)']}, {'name': 'Intensive Salvage Therapy', 'type': 'DRUG', 'armGroupLabels': ['Salvage Therapy (Arm B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Cancer Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Robert H. Lurie Comprehensive Cancer Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center Section of Hematology/Oncology', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46107', 'city': 'Beech Grove', 'state': 'Indiana', 'country': 'United States', 'facility': 'St. Francis Cancer Center', 'geoPoint': {'lat': 39.72199, 'lon': -86.08998}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville Brown Cancer Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '04901', 'city': 'Waterville', 'state': 'Maine', 'country': 'United States', 'facility': 'Maine General Medical Center Harold 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'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '18105', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Oncology and Hematology at Lehigh Valley', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Western Pennsylvania Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'UTMB Comprehensive Cancer Center', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M.D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '79410', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Joe Arrington Cancer Center', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'zip': '79415', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Tech University Health Sciences Center', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Cancer Therapy and Research Center at The University of TX Health Science Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84143', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain LDS Hospital', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver General Hospital/ 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'city': 'Gdansk', 'country': 'Poland', 'facility': 'Klinika Hematologii i Transplantologii', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '93-510', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Wojewódzki Szpital Specjalistyczny im. M. Kopernika', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '45-372', 'city': 'Opole', 'country': 'Poland', 'facility': 'Oddział Hematologii', 'geoPoint': {'lat': 50.67119, 'lon': 17.92604}}, {'zip': '02-776', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Instytut Hematologii i Transfuzjologii', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '50-367', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Akademia Medyczna we Wroclawlu', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'overallOfficials': [{'name': 'Jonathan Kolitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Shore University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jazz Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'The Leukemia and Lymphoma Society', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}