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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Myeloid Leukemia

Intervention: clofarabine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Genzyme, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company

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.

Clinical Details

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

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

Primary outcome: Overall Response Rate (ORR)

Secondary outcome:

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

Duration of Overall Response

Overall Survival

Duration of Complete Remission

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

Eligibility

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Dublin, Ireland

Bologna, Italy

Rome, Italy

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

Belfast, Northern Ireland, United Kingdom

Additional Information

Starting date: June 2004
Last updated: March 30, 2015

Page last updated: August 23, 2015

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