A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II)

NCT ID: NCT00373529

Last Updated: 2014-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2010-05-31

Brief Summary

Clolar (clofarabine injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.

This study will evaluate the efficacy of clofarabine in elderly patients with acute myelogenous leukemia (AML) who are unlikely to benefit from treatment with intensive chemotherapy regimens (cytarabine and anthracycline based regimens) used in younger patients with AML.

Conditions

Acute Myelogenous Leukemia; Acute Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clofarabine

Participants received an induction cycle of clofarabine 30 mg/m\^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m\^2/day intravenous infusion for 5 consecutive days.

Group Type: EXPERIMENTAL

clofarabine

Intervention Type: DRUG

Induction cycle 1: cycle 1 of clofarabine 30 mg/m^2/day as a 1-hour intravenous infusion for 5 consecutive days.

Reinduction (cycle 2) and/or Consolidation cycles (cycles 2-6): cycles repeated minimally every 28 days, of clofarabine 20 mg/m^2/day as a 1-hour intravenous infusion for 5 consecutive days.

Interventions

clofarabine

Induction cycle 1: cycle 1 of clofarabine 30 mg/m^2/day as a 1-hour intravenous infusion for 5 consecutive days.

Reinduction (cycle 2) and/or Consolidation cycles (cycles 2-6): cycles repeated minimally every 28 days, of clofarabine 20 mg/m^2/day as a 1-hour intravenous infusion for 5 consecutive days.

Intervention Type: DRUG

Other Intervention Names

clolar

Eligibility Criteria

Inclusion Criteria

• Diagnosis of AML (de novo, secondary or with an antecedent hematologic disorder [AHD])
• Age ≥ 60 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Presence of at least one adverse prognostic factor: Age ≥ 70 years; or AHD; or ECOG performance status of 2; or Intermediate or unfavorable (i.e., adverse) karyotype defined as any cytogenetic profile except the presence of any of the following:

• t(8;21)(q22;q22)
• inv(16)(p13;q22 or t(16;16)(p13;q22)
• t(15;17)(q22;q12) and variants.
• Adequate renal and hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN; and Serum creatinine ≤ 1.0 mg/dL; if serum creatinine > 1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be > 60 mL/min/1.73 m^2 as calculated by the Modification of Diet in Renal Disease (MDRD) equation
• Adequate cardiac function: left ventricular ejection fraction (LVEF) ≥ 40% or left ventricular fractional shortening ≥ 22%

Exclusion Criteria

• Diagnosis of acute promyelocytic leukemia
• Prior treatment with clofarabine
• Prior treatment for AML or an antecedent hematologic disorder
• Prior hematopoietic stem cell transplant (HSCT)
• Prior radiation therapy to the pelvis
• Investigational agent received within 30 days prior to the first dose of study drug
• Ongoing uncontrolled systemic infection
• Diagnosis of another malignancy, unless the patient has been disease-free for at least 5 years following the completion of curative intent therapy with the following exceptions: Patients with treated non-melanoma skin cancer, in-situ carcinoma or cervical intraepithelial neoplasia regardless of 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 based on PSA value are eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed
• Clinical evidence of central nervous system (CNS) involvement
• Severe concurrent medical condition or psychiatric disorder that would preclude study participation
• Positive human immunodeficiency virus (HIV) test

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

Mayo Clinical Hospital

Phoenix, Arizona, United States

Arizona Cancer Center

Tucson, Arizona, United States

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Scripps Cancer Center

San Diego, California, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Cancer Center of Central Connecticut

Southington, Connecticut, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Medical College of Georgia

Augusta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Mount Sinai School of Medicine

New York, New York, United States

Oregon Health and Science University

Portland, Oregon, United States

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of MD Anderson Cancer Center

Houston, Texas, United States

Cancer Care Centers of South Texas

San Antonio, Texas, United States

University of Utah - Huntsman Cancer Institute

Salt Lake City, Utah, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

West Virginia University - HSC

Morgantown, West Virginia, United States

Countries

United States

References

Kantarjian HM, Erba HP, Claxton D, Arellano M, Lyons RM, Kovascovics T, Gabrilove J, Craig M, Douer D, Maris M, Petersdorf S, Shami PJ, Yeager AM, Eckert S, Abichandani R, Faderl S. Phase II study of clofarabine monotherapy in previously untreated older adults with acute myeloid leukemia and unfavorable prognostic factors. J Clin Oncol. 2010 Feb 1;28(4):549-55. doi: 10.1200/JCO.2009.23.3130. Epub 2009 Dec 21.

Reference Type: RESULT

PMID: 20026805 (View on PubMed)

Other Identifiers

CLO24300606

Identifier Type: -

Identifier Source: org_study_id