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

NCT00373529 | Completed Phase 2 Results DMC

• 1 other identifier: CLO24300606
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 20

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

Keywords

Acute myelogenous leukemia; Acute myeloid leukemia; newly Diagnosed AML; Clofarabine; CLASSIC II; CLO243

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Overall Remission (OR) After No More Than Two Cycles (Approximately Month 2)

  Best response was assessed by the Independent Response Review Panel(IRRP) after two cycles of treatment. Overall remission(OR) is the sum of complete remission(CR) and complete remission in the absence of platelet recovery(CRp). CR includes normal values for peripheral blood cell counts (absolute neutrophil and platelet) and leukemic blast cells from bone marrow biopsy or aspirate, and absence of extramedullary disease. Partial remission(PR) includes recovery of peripheral blood cells with improved but still abnormal values in leukemic blast cells.

  approximately Month 2

Secondary Outcomes (5)

• Kaplan Meier Estimate for Duration of Remission (DOR)

  Up to 2 years

• Kaplan Meier Estimate for Disease-free Survival (DFS)

  Up to 2 years

• Kaplan Meier Estimates for Overall Survival (OS)

  Up to 2 years

• Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment and Follow-up Periods

  Up to 2 years

• Percentage of Participants Who Died Within Thirty Days of Treatment (30-day Mortality Rate)

  up to Day 30

Other Outcomes (1)

• Number of Participants Achieving Overall Remission After A Maximum of Two Cycles by Subgroup of Baseline Prognostic Factors

  approximately Month 2

Study Arms (1)

Clofarabine

EXPERIMENTAL

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.

Drug: clofarabine

Interventions

clofarabine 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.

Also known as: clolar

Clofarabine

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (20)

Mayo Clinical Hospital

Phoenix, Arizona, United States

Location

Arizona Cancer Center

Tucson, Arizona, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Location

Scripps Cancer Center

San Diego, California, United States

Location

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Location

Cancer Center of Central Connecticut

Southington, Connecticut, United States

Location

Emory University School of Medicine

Atlanta, Georgia, United States

Location

Medical College of Georgia

Augusta, Georgia, United States

Location

Rush University Medical Center

Chicago, Illinois, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Location

Mount Sinai School of Medicine

New York, New York, United States

Location

Oregon Health and Science University

Portland, Oregon, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Location

University of MD Anderson Cancer Center

Houston, Texas, United States

Location

Cancer Care Centers of South Texas

San Antonio, Texas, United States

Location

University of Utah - Huntsman Cancer Institute

Salt Lake City, Utah, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, United States

Location

West Virginia University - HSC

Morgantown, West Virginia, United States

Location

Related Publications (1)

• 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.

  PMID: 20026805 RESULT

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Clofarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Nucleotides; Ribonucleotides

Results Point of Contact

• Title: Genzyme Medical Information
• Organization: Genzyme Corporation

800-745-4447

Study Officials

• Medical Monitor

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2006
• First Posted: September 8, 2006
• Study Start: October 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2010
• Last Updated: April 14, 2014
• Results First Posted: March 24, 2011

Record last verified: 2014-03

Locations

US (20)