- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00373529
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
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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Arizona
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Phoenix, Arizona, Forente stater
- Mayo Clinical Hospital
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Tucson, Arizona, Forente stater
- Arizona Cancer Center
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California
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Los Angeles, California, Forente stater
- USC/Norris Comprehensive Cancer Center and Hospital
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San Diego, California, Forente stater
- Scripps Cancer Center
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Colorado
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Denver, Colorado, Forente stater
- Rocky Mountain Cancer Centers
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Connecticut
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Southington, Connecticut, Forente stater
- Cancer Center of Central Connecticut
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Georgia
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Atlanta, Georgia, Forente stater
- Emory University School of Medicine
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Augusta, Georgia, Forente stater
- Medical College of Georgia
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Illinois
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Chicago, Illinois, Forente stater
- Rush University Medical Center
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Massachusetts
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Boston, Massachusetts, Forente stater
- Beth Israel Deaconess Medical Center
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Michigan
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Ann Arbor, Michigan, Forente stater
- University of Michigan Comprehensive Cancer Center
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New York
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New York, New York, Forente stater
- Mount Sinai School of Medicine
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Oregon
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Portland, Oregon, Forente stater
- Oregon Health and Science University
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Pennsylvania
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Hershey, Pennsylvania, Forente stater
- Penn State Hershey Medical Center
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Tennessee
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Nashville, Tennessee, Forente stater
- Vanderbilt University Medical Center
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Texas
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Houston, Texas, Forente stater
- University of MD Anderson Cancer Center
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San Antonio, Texas, Forente stater
- Cancer Care Centers of South Texas
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Utah
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Salt Lake City, Utah, Forente stater
- University of Utah - Huntsman Cancer Institute
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Washington
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Seattle, Washington, Forente stater
- Seattle Cancer Care Alliance
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West Virginia
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Morgantown, West Virginia, Forente stater
- West Virginia University - HSC
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
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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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants Achieving Overall Remission (OR) After No More Than Two Cycles (Approximately Month 2)
Tidsramme: approximately Month 2
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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.
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approximately Month 2
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Kaplan Meier Estimate for Duration of Remission (DOR)
Tidsramme: Up to 2 years
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DOR was defined as the number of days from achievement of OR as assessed by the Independent Response Review Panel (IRRP) until IRRP-determined disease recurrence or death (any cause), plus 1 day.
Participants who initiated alternative antileukemic treatment while in remission were censored on the date the therapy was initiated or on the date of last follow-up.
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Up to 2 years
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Kaplan Meier Estimate for Disease-free Survival (DFS)
Tidsramme: Up to 2 years
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DFS was defined as the number of days from achievement of IRRP-determined overall response until IRRP-determined disease recurrence or death (any cause), regardless of intervening alternative antileukemic treatment, plus 1 day.
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Up to 2 years
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Kaplan Meier Estimates for Overall Survival (OS)
Tidsramme: Up to 2 years
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OS was defined as the number of days from first dose of clofarabine until death for all participants, plus 1 day.
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Up to 2 years
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Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment and Follow-up Periods
Tidsramme: Up to 2 years
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Participants with AEs that occurred during the treatment and follow-up periods. AEs were classified according to severity (graded using National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) and relationship to study drug. Treatment emergent is defined as any event that either first presents after baseline or worsens in severity after baseline. NCI Common Terminology Criteria for Severity: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5= Death related to AE |
Up to 2 years
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Percentage of Participants Who Died Within Thirty Days of Treatment (30-day Mortality Rate)
Tidsramme: up to Day 30
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Percentage of participants who died within 30 days of the first dose of study drug, regardless of cause.
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up to Day 30
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants Achieving Overall Remission After A Maximum of Two Cycles by Subgroup of Baseline Prognostic Factors
Tidsramme: approximately Month 2
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The number of participants within each subgroup of baseline prognostic factors of the full analysis set who achieved a best response of either a complete response (CR) or a complete response in the absence of platelet recovery (CRp) as determined by the Independent Response Review Panel following a maximum of two cycles of treatment.
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approximately Month 2
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CLO24300606
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