Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Clofarabine

Antimetabolites

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.

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.

clofarabine

Medical Monitor

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.

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

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.

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.

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.

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.

OS was defined as the number of days from first dose of clofarabine until death for all participants, plus 1 day.

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

Percentage of participants who died within 30 days of the first dose of study drug, regardless of cause.

Genzyme, a Sanofi Company

In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.

Age, Continuous

Sex: Female, Male

American Indian or Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

Other

Race

Hispanic or Latino

Not Hispanic or Latino

Ethnicity

Height

Weight

>= 70 years

< 70 years

Being 70 years old or older is considered an adverse prognostic factor.

Age at Enrollment

Not reported

The most common risk factor for acute myelogenous leukemia (AML) is the presence of an antecedent hematologic disorder.

Antecedent Hematologic Disorder

ECOG 5

ECOG 4

ECOG 3

ECOG 2

ECOG 1

ECOG 0

Another prognostic factor. Eastern Cooperative Oncology Group Performance Status (ECOG PS) is a scale ranging from 0-5, with 0=fully active, 1=capable of light work, 2=no work but all self-care, 3=limited self-care, 4=completely disabled, 5=dead.

Eastern Cooperative Oncology Group Performance Status

Intermediate

Unfavorable

Favorable

A favorable cytogenetic karyotype is associated with a positive prognostic outcome; an unfavorable cytogenetic karyotype is associated with a negative prognostic outcome. An intermediate karyotype is typically associated with a better outcome than a favorable karyotype, but also associated with a worse outcome compared to a favorable karyotype.

Karyotype

0 Adverse Prognostic Factors

1 Adverse Prognostic Factor

2 Adverse Prognostic Factors

3 Adverse Prognostic Factors

4 Adverse Prognostic Factors

Participant counts by the number of adverse prognostic factors, which include age \>= 70 years, antecedent hematologic disorder = Yes, ECOG = 2, and karyotype = intermediate or unfavorable.

Participants Summarized by Number of Adverse Prognostic Factors

Participant counts by the number of adverse prognostic factors, which include age \>= 70 years, antecedent hematologic disorder = Yes, ECOG = 2, and karyotype = unfavorable.

Participants Summarized by Number of Adverse Prognostic Factors Excluding Intermediate Karyotype

The diagnosis of secondary AML is based upon investigator judgment regarding prior ionizing radiation and/or chemotherapy.

Secondary acute myeloid leukemia (AML) at baseline

Genzyme Medical Information

Overall Remission (OR=CR+CRp)

Complete Remission (CR)

Complete Remission w/o platelet recovery (CRp)

Partial Remission (PR)

Treatment Failure (TF)

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

Full analysis set (FAS) of participants who achieved remission.

Kaplan Meier Estimate for Duration of Remission (DOR)

Kaplan Meier Estimate for Disease-free Survival (DFS)

Kaplan Meier Estimates for Overall Survival (OS)

Treatment-emergent AEs (TEAE)

Treatment-emergent AEs related to study drug

Treatment-emergent serious AEs

Treatment-emergent serious AEs related to drug

Discontinued due to AEs

Died w/i treatment period-w/i 45 days of last dose

Died due to drug-related AEs

Died within 30 days of first dose

Died w/i 30 days of first dose due to related AEs

Grade 1: maximum severity rating for any TEAE

Grade 2: maximum severity rating for any TEAE

Grade 3: maximum severity rating for any TEAE

Grade 4: maximum severity rating for any TEAE

Grade 5: maximum severity rating for any TEAE

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

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

Age >=70 (n=69)

Age <70 (n=43)

Antecedent hematologic disorder - Yes (n=41)

Antecedent hematologic disorder - No (n=67)

Antecedent hematologic disorder-Not reported (n=4)

ECOG Performance Status = 0-1 (n=87)

ECOG Performance Status = 2 (n=25)

Karyotype = Intermediate (n=46)

Karyotype = Unfavorable (n=62)

Karyotype = Not Reported (n=4)

Full analysis set (FAS) of participants who achieved remission and had baseline prognostic factor

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

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II)	NCT00373529	Acute Myelogeno... Acute Myeloid L...	clofarabine	60 Years -	Sanofi
A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II)	NCT00373529	Acute Myelogeno... Acute Myeloid L...	clofarabine	60 Years -	Sanofi
A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II)	NCT00373529	Acute Myelogeno... Acute Myeloid L...	clofarabine	60 Years -	Sanofi

Spots Global Cancer Trial Database for clo243

Every month we try and update this database with for clo243 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for clo243

Every month we try and update this database with for clo243 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for clo243 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.