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

March 30, 2015 updated by: Genzyme, a Sanofi Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland
  • Italy
      • Bologna, Italy
      • Rome, Italy
  • United Kingdom
      • Aberdeen, United Kingdom
      • Birmingham, United Kingdom
      • Cardiff, United Kingdom
      • Edinburgh, United Kingdom
      • Leicester, United Kingdom
      • Liverpool, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • Nottingham, United Kingdom
      • Somerset, United Kingdom
      • Taunton, United Kingdom
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Clofarabine
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.
Drug: clofarabine
Other Names:
  • tradename US = Clolar
  • tradename EU = Evoltra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: At month 20

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.
At month 20

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial)
Time Frame: At month 20

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.
At month 20
Duration of Overall Response
Time Frame: From 20 months up to 48 months
Duration was calculated by Kaplan-Meier estimates
From 20 months up to 48 months
Overall Survival
Time Frame: From 20 months up to 48 months
Calculated by Kaplan-Meier estimates
From 20 months up to 48 months
Duration of Complete Remission
Time Frame: From 20 months up to 48 months
Duration was calculated by Kaplan- Meier estimates
From 20 months up to 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Collaborators

Bioenvision

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (ACTUAL)

June 1, 2006

Study Completion (ACTUAL)

March 1, 2008

Study Registration Dates

First Submitted

June 17, 2009

First Submitted That Met QC Criteria

June 18, 2009

First Posted (ESTIMATE)

June 19, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 30, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIOV-121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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