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

Clofarabine 30 mg/m\^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m\^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.

clofarabine

Medical Monitor

The purpose of the study is to determine if treatment of older patients indicated with untreated Acute Myeloid Leukemia (AML) who are not considered to be suitable for intensive chemotherapy, can effectively be treated with Clofarabine.

Note: This clinical trial was conducted by Bioenvision Ltd. Bioenvision Ltd. was acquired by Genzyme Corporation Oct 2007.

A Study of Clofarabine in Older Patients With Acute Myeloid Leukemia (AML) for Whom Chemotherapy Is Not Suitable

A Phase II Trial of Clofarabine in Older Patients With Acute Myeloid Leukemia for Whom Intensive Chemotherapy is Not Considered Suitable

ORR rate was defined as the sum of the number of participants in the study population with complete remission (CR), complete remission with incomplete blood count recovery (CRi), or partial remission (PR) divided by the total number of participants in the study population.

ORR rate was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment. The ORR was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment.

Response was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment.

Response was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment.

Duration was calculated by Kaplan-Meier estimates

Duration was calculated by Kaplan- Meier estimates

Bioenvision

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.

Clofarabine 30 mg/m\^2/day intravenously over 1 hour for 5 days every 28 to 42 days(one cycle) and 20 mg/m\^2/day intravenously over 1 hour for 5 days every 29 to 43 days for second and subsequent cycles,up to a maximum of 3 cycles.

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Ireland

Italy

United Kingdom

Region of Enrollment

Favourable

Intermediate

Adverse

Missing/Unknown

Diagnostic criteria of Grimwade for younger patients

Cytogenetics (1998)

Diagnostic criteria of Grimwade for older patients

Cytogenetics (2001)

De Novo

Secondary

Type of Acute Myeloid Leukemia (AML)

25-99.9

>=100

White Blood Cell Count (10^9/L)

<=50

Glomerular Filtration Rate (mL/min/1.73m^2)

Number of Co-morbidities

100%

Missing

Karnofsky performance scale is used by doctors to classify patient's functional impairment level. The lower the number the higher the impairment in typical daily activities by the disease.

Typical classification examples: 100% normal with no evidence of disease, 90% able to carry on normal activity with minor signs of illness, 80% normal activity but requiring effort, 70% able to care for self but unable to work or carry on other normal activities, 60% able to care for most needs but requires occasional assistance, 50% considerable assistance and frequent medical care required, etc..

Karnofsky Performance Status

Baseline Characteristics provided for Full Analysis Set (FAS) population, defined as all participants with a confirmed diagnosis of AML who received at least one dose of clofarabine

Trial Transparency Team

The efficacy analysis was performed on the primary analysis population, the Full Analysis Set population, which consisted of all participants with a diagnosis of AML confirmed by the Investigator who received at least one dose (partial or complete) of clofarabine.

Overall Response Rate (ORR)

Complete response

Complete with incomplete blood count recovery

Partial response

The efficacy analyses were performed on the primary analysis population, the Full Analysis Set population, which consisted of all participants with a diagnosis of AML confirmed by the Investigator who received at least one dose (partial or complete) of clofarabine.

Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial)

The analysis were performed on the primary analysis population, the Full Analysis Set population. Defined as the median duration of overall response (CR+CRi+PR) in participants who achieved CR, CRi or PR only

Duration of Overall Response

Overall Survival

The analysis were performed on the primary analysis population, the Full Analysis Set population. Defined as the median duration of participants who achieved CR+CRi only

Duration of Complete Remission

Clofarabine 30 mg/m\^2/day intravenously over 1 hour for 5 days every 29 to 43 days

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Clofarabine in Older Patients With Acute Myeloid Leukemia (AML) for Whom Chemotherapy Is Not Suitable	NCT00924443	Acute Myeloid L...	clofarabine	65 Years -	Sanofi
A Study of Clofarabine in Older Patients With Acute Myeloid Leukemia (AML) for Whom Chemotherapy Is Not Suitable	NCT00924443	Acute Myeloid L...	clofarabine	65 Years -	Sanofi

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