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


Phase 2
65 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Time Frame:

minimum of 24 months and maximum up to end of study

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

BIOV-121

NCT ID:

NCT00924443

Start Date:

June 2004

Completion Date:

March 2008

Related Keywords:

  • Acute Myeloid Leukemia
  • acute myelogenous leukemia
  • acute myeloid leukemia
  • clolar
  • evoltra
  • clofarabine
  • untreated acute leukemia
  • adult acute leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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