Trial of CPX-351 in Adult Patients With First Relapse Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute, Myeloid, Leukemia, Adult, First, Relapse, AML, Acute Myelogenous leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Acute myelocytic leukemia
Eligibility Criteria
Inclusion Criteria:
- Ability to understand and voluntarily sign an informed consent form
- Age ≥18 and ≤65 years at the time of relapse
- Pathological confirmation of relapsed AML after initial CR of >1 month duration
- Eastern Cooperative Oncology Group (ECOG) performance status 0- 2
- Able to adhere to the study visit schedule and other protocol requirements
Laboratory values fulfilling the following:
- Serum creatinine < 2.0 mg/dL
- Serum total bilirubin < 2.0 mg/dL
- Serum alanine aminotransferase or aspartate aminotransferase <3xULN Note: If elevated liver enzymes are related to disease; contact medical monitor to discuss.
- Cardiac ejection fraction > 50% by echocardiography or MUGA scan
- 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.
Exclusion Criteria:
- 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
- Patients with acute promyelocytic leukemia [t(15;17)]
- Total lifetime anthracycline exposure exceeding the equivalent of 368 mg/m2 of daunorubicin (or equivalent) prior to start of study therapy
- Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent
- 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
- Clinical evidence of active CNS leukemia
- 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
- 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.
- Current evidence of invasive fungal infection (blood or tissue culture); active hepatitis C infection or known HIV infection
- Hypersensitivity to cytarabine, daunorubicin or liposomal products
- History of Wilson's disease or other copper-related disorder
- 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.
- Woman who are pregnant or breast feeding
Sites / Locations
- Arizona Cancer Center
- UCLA
- Cedars Sinai Medical Center
- UC Davis Cancer Center
- University of Colorado Cancer Center
- Northwestern University Robert H. Lurie Comprehensive Cancer Center
- Rush University Medical Center
- University of Chicago Medical Center Section of Hematology/Oncology
- St. Francis Cancer Center
- University of Louisville Brown Cancer Center
- Maine General Medical Center Harold Alfond Center for Cancer Care
- Johns Hopkins University
- St. Louis University Medical Center
- The Cancer Center, Hackensack University Medical Center
- North Shore LIJ Center for Advanced Medicine Monter Cancer Center
- Weil Cornell Medical Center
- New York Medical College
- Montefiore Medical Center
- Blumenthal Cancer Center/Mecklenburg Medical Group
- Duke Comprehensive Cancer Center
- Jewish Hospital of Cincinatti
- Oregon Health and Science University
- Oncology and Hematology at Lehigh Valley
- Western Pennsylvania Hospital
- UTMB Comprehensive Cancer Center
- M.D. Anderson Cancer Center
- Joe Arrington Cancer Center
- Texas Tech University Health Sciences Center
- Cancer Therapy and Research Center at The University of TX Health Science Center
- Intermountain LDS Hospital
- Medical College of Wisconsin
- Vancouver General Hospital/ British Columbia Cancer Agency
- Cancer Care Manitoba
- Service des Maladies du Sang CHU de Lille, Hopital Claude Huriez
- Service des Maladies du Sang Hopital Haut-Leveque
- Service d'Hématologie CHU Toulouse-Hôpital Purpan
- Service d'Hématologie et Médecine Interne CHU de Nancy-Hôpital de Brabois
- Klinika Hematologii i Transplantologii
- Wojewódzki Szpital Specjalistyczny im. M. Kopernika
- Oddział Hematologii
- Instytut Hematologii i Transfuzjologii
- Akademia Medyczna we Wroclawlu
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
CPX-351 (Arm A)
Salvage Therapy (Arm B)
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
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