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

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
clofarabine
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring acute myelogenous leukemia, acute myeloid leukemia, clolar, evoltra, clofarabine, untreated acute leukemia, adult acute leukemia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Provide signed, written informed consent
  • Have untreated AML according to World Health Organization (WHO) classification
  • Male or post-menopausal female ≥ 65 years of age
  • Unsuitable for intensive chemotherapy
  • Be able to comply with study procedures and follow-up examination
  • Male patient who are fertile agree to use and effective barrier method of birth control to avoid pregnancies
  • Have adequate liver and renal function as indicated by certain laboratory values

Exclusion Criteria:

  • Received previous treatment with clofarabine
  • Are receiving other chemotherapy or corticosteroids (low-dose corticosteroid for pre-medication purposes are allowed)
  • Have received prior treatment for leukemia. Growth factor, cytokine support, leukopheresis or hydroxyurea will be allowed but must be discontinued at least 24 hours prior to start of treatment with clofarabine
  • Have a psychiatric disorder that would interfere with consent, study participation, or follow-up
  • Have an active, uncontrolled systemic infection
  • Are currently participating in other investigational drug studies or having received other investigational drugs within the previous 30 days
  • Have symptomatic central nervous system (CNS) involvement
  • Blast transformation of chronic myeloid leukemia or acute promyelocytic leukemia

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Clofarabine

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)
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.

Secondary Outcome Measures

Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial)
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 of Overall Response
Duration was calculated by Kaplan-Meier estimates
Overall Survival
Calculated by Kaplan-Meier estimates
Duration of Complete Remission
Duration was calculated by Kaplan- Meier estimates

Full Information

First Posted
June 17, 2009
Last Updated
March 30, 2015
Sponsor
Genzyme, a Sanofi Company
Collaborators
Bioenvision
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1. Study Identification

Unique Protocol Identification Number
NCT00924443
Brief Title
A Study of Clofarabine in Older Patients With Acute Myeloid Leukemia (AML) for Whom Chemotherapy Is Not Suitable
Official Title
A Phase II Trial of Clofarabine in Older Patients With Acute Myeloid Leukemia for Whom Intensive Chemotherapy is Not Considered Suitable
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company
Collaborators
Bioenvision

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
acute myelogenous leukemia, acute myeloid leukemia, clolar, evoltra, clofarabine, untreated acute leukemia, adult acute leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clofarabine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
clofarabine
Other Intervention Name(s)
tradename US = Clolar, tradename EU = Evoltra
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
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.
Time Frame
At month 20
Secondary Outcome Measure Information:
Title
Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial)
Description
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.
Time Frame
At month 20
Title
Duration of Overall Response
Description
Duration was calculated by Kaplan-Meier estimates
Time Frame
From 20 months up to 48 months
Title
Overall Survival
Description
Calculated by Kaplan-Meier estimates
Time Frame
From 20 months up to 48 months
Title
Duration of Complete Remission
Description
Duration was calculated by Kaplan- Meier estimates
Time Frame
From 20 months up to 48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provide signed, written informed consent Have untreated AML according to World Health Organization (WHO) classification Male or post-menopausal female ≥ 65 years of age Unsuitable for intensive chemotherapy Be able to comply with study procedures and follow-up examination Male patient who are fertile agree to use and effective barrier method of birth control to avoid pregnancies Have adequate liver and renal function as indicated by certain laboratory values Exclusion Criteria: Received previous treatment with clofarabine Are receiving other chemotherapy or corticosteroids (low-dose corticosteroid for pre-medication purposes are allowed) Have received prior treatment for leukemia. Growth factor, cytokine support, leukopheresis or hydroxyurea will be allowed but must be discontinued at least 24 hours prior to start of treatment with clofarabine Have a psychiatric disorder that would interfere with consent, study participation, or follow-up Have an active, uncontrolled systemic infection Are currently participating in other investigational drug studies or having received other investigational drugs within the previous 30 days Have symptomatic central nervous system (CNS) involvement Blast transformation of chronic myeloid leukemia or acute promyelocytic leukemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
City
Dublin
Country
Ireland
City
Bologna
Country
Italy
City
Rome
Country
Italy
City
Belfast
State/Province
Northern Ireland
Country
United Kingdom
City
Aberdeen
Country
United Kingdom
City
Birmingham
Country
United Kingdom
City
Cardiff
Country
United Kingdom
City
Edinburgh
Country
United Kingdom
City
Leicester
Country
United Kingdom
City
Liverpool
Country
United Kingdom
City
London
Country
United Kingdom
City
Manchester
Country
United Kingdom
City
Nottingham
Country
United Kingdom
City
Somerset
Country
United Kingdom
City
Taunton
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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