A Study of Clofarabine and Cytarabine for Older Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)(CLASSIC I)
Acute Myelogenous Leukemia
About this trial
This is an interventional treatment trial for Acute Myelogenous Leukemia focused on measuring acute myelogenous leukemia, acute myeloid leukemia, relapsed AML, refractory AML, clofarabine, cytarabine, CLO341, clolar
Eligibility Criteria
Inclusion Criteria: Have a diagnosis of Acute Myelogenous Leukemia (AML) according to World Health Organization (WHO) classification Relapsed after receiving up to 2 prior induction regimens (i.e. first or second relapse)or are refractory to not more than one prior combination chemotherapy induction regimen Be ≥ 55 years of age Have an Eastern Cooperative Oncology Group (ECOG) score of 0-2 Be able to comply with study procedures and follow-up examinations Be nonfertile or agree to use birth control during the study through the end of treatment visit and for at least 90 days after the last dose of study drug Have adequate liver and renal function as indicated by certain laboratory values Exclusion Criteria: Received previous treatment with clofarabine Received bolus, intermediate or high-dose cytarabine as induction therapy unless certain remission criteria are met Have received a hematopoietic stem cell transplant (HSCT) within the previous 3 months Have moderate or severe graft versus host disease (GVHD), whether acute or chronic Are receiving any other chemotherapy or investigational therapy. Patients must have been off prior AML therapy for at least 2-6 weeks prior to entering study. Have a psychiatric disorder that would interfere with consent, study participation, or follow-up Have an active, uncontrolled infection Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system Have been diagnosed with another malignancy, unless disease-free for at least 5 years; patients with treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed; patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease are eligible if hormonal therapy has been initiated or the malignancy has been surgically removed. Have clinical evidence suggestive of central nervous system (CNS) involvement with leukemia unless lumbar puncture confirms absence of leukemic blasts in the cerebrospinal fluid(CSF) Known HIV positivity Are pregnant or lactating
Sites / Locations
- Mayo Clinical Hospital
- Arizona Cancer Center
- University of Arkansas for Medical Sciences, Arkansas Cancer Research Center
- Scripps Cancer Center
- UCLA School of Medicine
- University of Southern California, Kenneth Norris Cancer Center
- Stanford Comprehensive Cancer Center
- University of Colorado Health Science Center
- Rocky Mountain Cancer Center
- Cancer Center of Central Connecticut
- Northwestern University
- Rush University Medical Center
- Evanston Northwestern Healthcare
- University of Kansas Medical Center
- University of Kentucky, Markey Cancer Center
- Louisiana State University Health Science Center
- Harold Alfond Center for Cancer Care
- Beth Israel Deaconess Medical Center
- Josephine Ford Cancer Center
- Dartmouth Hitchcock Medical Center
- The Cancer Center at Hackensack University Medical Center
- Roswell Park Cancer Center
- Mt. Sinai School of Medicine
- New York Medical Center
- Mecklenburg Medical Group
- Duke University Medical Center
- Wake Forest University School of Medicine
- Gabrail Cancer Center
- University of Oklahoma Health Sciences Center
- Oregon Health Science University
- Medical University of South Carolina
- University of Tennessee Medical Center
- Sarah Cannon Research Institute
- Vanderbilt University Medical Center
- UT Southwestern Medical Center, Simmons Comprehensive Cancer Center
- MD Anderson Cancer Center
- Cancer Care Centers of South Texas
- University of Texas Health Sciences Center
- University of Utah - Huntsman Cancer Institute
- West Virginia University Hospitals, Mary Babb Randolph Cancer Center
- Medical College of Wisconsin
- Saint John Regional Hospital
- Juravinski Cancer Center
- Hopital Maisonneuve-Rosemont
- Service Maladies du Sang, CHU Angers
- Hopital Claude Huriez CHRU de Lille
- Hopital Edouard Herriot
- Institut Paoli Calmettes
- Hopital Hotel Dieu
- Hopital Purpan
- Medizinische Hochschule Hannover, Zentrum fur Innere Medizin, Abt. Haematologie / Onkologie
- Medizinische Klinik der Technischen, Universität München
- Universitatsklinikum Ulm
- Ospedali Riuniti Bergamo
- A.O Ospedale Niguarda Ca'Granda
- N.O. San Gerardo
- Azienda Ospedaliera "Antonio Cardarelli"
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
clofarabine (IV formulation) and cytarabine
placebo and cytarabine
Participants received clofarabine (40 mg/m^2) administered as a 1-hour infusion followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour infusion. Participants could receive up to 3 cycles of treatment (induction, re-induction, and consolidation) Complete induction cycle = 5 consecutive days of treatment Re-induction cycle = 5 consecutive days of treatment at the original or modified dose Consolidation cycle = 4 consecutive days of treatment at the original or modified dose
Participants received placebo administered as a 1-hour infusion followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour infusion. Patients could receive up to 3 cycles of treatment (induction, re-induction, and consolidation)