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A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Phase II Study of Single Agent Clofarabine in Previously Untreated Older Adult Patients With Acute Myelogenous Leukemia (AML) for Whom Standard Induction Chemotherapy is Unlikely to be of Benefit

NCT00373529•Genzyme, a Sanofi Company

View on ClinicalTrials.gov

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.

Eligibility

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (20)

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

Key Dates

Start Date

October 1, 2006

Primary Completion Date

May 1, 2008

Completion Date

May 1, 2010

Last Updated

April 14, 2014

Enrollment

116

ACTUAL participants

Conditions

Acute Myelogenous LeukemiaAcute Myeloid Leukemia

Interventions

clofarabine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 14, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

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