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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01247493
• Collaborator: (none)
• Enrollment: 108
• Location: 1
• Duration (Months): 37
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Drug: induction chemotherapy (fludarabine, cytarabine, idarubicin)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 108 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jul 1, 2010

Outcome Measures

Primary Outcome Measures

1. Complete remission rate []

   Rate of complete remssion (CR) after two cycles of m-FLAI induction

Secondary Outcome Measures

1. Rate of serious adverse events (SAE) []

   Number of patients dying from SAE related to m-FLAI induction

2. 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

3. overall survival []

   Overall survival defined as a period from study enrollment to death from any cause

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Inho Kim, professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01247493
• Other Study ID Numbers: H-0704-029-205
• First Posted: Nov 24, 2010
• Last Update Posted: Nov 24, 2010
• Last Verified: Nov 1, 2010

• Keywords provided by , ,: fludarabine; AML; Efficacy; tolerability
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Cytarabine; Fludarabine; Idarubicin

Study Results

No Results Posted as of Nov 24, 2010