Modified-FLAI Induction and Consolidation Chemotherapy in Elderly Patient With Acute Myeloid Leukemia (AML)

Acute Myeloid Leukemia Clinical Trial

— m-FLAI  

Official title:

Multicenter, Phase 2 Clinical Trial Evaluating the Efficacy and Tolerability of Induction and Consolidation Chemotherapy Comprising Fludarabine, Cytarabine, and Attenuated-dose Idarubicin in Elderly Patients With AML(Acute Myeloid Leukemia)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01247493
• Other study ID #: H-0704-029-205
• Status: Completed
• Phase: Phase 2
• First received: November 17, 2010
• Last updated: November 23, 2010
• Start date: June 2007
• Est. completion date: July 2010

Study information

• Verified date: November 2010
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A phase II clinical trial evaluating the efficacy and tolerability of induction and consolidation chemotherapy comprising Fludarabine, cytarabine and attenuated-dose Idarubicin (modified-FLAI) in the elderly patients with acute myeloid leukemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: July 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• previously untreated AML (excluding acute promyelocytic leukemia)

• age greater than 60 years old

• ECOG PS (Eastern Cooperative Oncology Group Performance scale) less than 2

• adequate hepatic/ renal/ cardiac function

Exclusion Criteria:

• acute promyelocytic leukemia

• significant cardiac disease

• combined non-hematologic malignancy

• aleukemic leukemia (only granulocytic sarcoma)

• CNS (Central Nervous system) involvement

• significant comorbidity/ uncontrollable bleeding tendency

Study Design

Endpoint Classification: 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:
• induction chemotherapy (fludarabine, cytarabine, idarubicin)
fludarabine, cytarabine, idarubicin

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete remission rate	Rate of complete remssion (CR) after two cycles of m-FLAI induction		No
Secondary	Rate of serious adverse events (SAE)	Number of patients dying from SAE related to m-FLAI induction		Yes
Secondary	Event Free Survival	Event free survival defined as a period from study enrollment to death by from cause or relapse of disease after complete remission		No
Secondary	overall survival	Overall survival defined as a period from study enrollment to death from any cause		No
Secondary	Predictive factors for Complete remission	Compare complete remission rate according to existence of specific chromosome abnormality and Charlson comorbidity index to evaluate predicative impact of these factors.		No