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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00924443
• Other study ID #: BIOV-121
• Status: Completed
• Phase: Phase 2
• First received: June 17, 2009
• Last updated: March 30, 2015
• Start date: June 2004
• Est. completion date: March 2008

Study information

• Verified date: March 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyIreland: Irish Medicines BoardItaly: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: March 2008
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• clofarabine

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company	Bioenvision

Countries where clinical trial is conducted

Ireland,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At month 20	No
Secondary	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.	At month 20	No
Secondary	Duration of Overall Response	Duration was calculated by Kaplan-Meier estimates	From 20 months up to 48 months	No
Secondary	Overall Survival	Calculated by Kaplan-Meier estimates	From 20 months up to 48 months	No
Secondary	Duration of Complete Remission	Duration was calculated by Kaplan- Meier estimates	From 20 months up to 48 months	No