Optimal Treatment Strategy Based on for Pediatric AML

Pediatric Acute Myeloid Leukemia Clinical Trial

Official title:

Optimal Treatment Strategy Based on Prognostic Groups for Pediatric de Novo Acute Myeloid Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02848183
• Other study ID #: 2015-11-028
• Status: Recruiting
• Phase: Phase 2
• First received: July 26, 2016
• Last updated: July 26, 2016
• Start date: January 2016

Study information

• Verified date: July 2016
• Source: Samsung Medical Center
• Contact: Keon Hee Yoo, MD, PhD
• Phone: 82-2-3410-3532
• Email: hema2170[@]skku.edu
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to optimize therapy according to the known risk factors and treatment response in pediatric acute myeloid leukemia (AML)

Description:

I. Risk group assessment Favorable prognosis group: Low risk features + Good response

Intermediate prognosis group:

1. Low risk features + Delayed response-1

2. Standard risk features + Good response

3. Standard risk features + Delayed response-1

Poor prognosis group:

1. Any high risk features irrespective of treatment response

2. Any delayed response-2 irrespective of risk features

3. Any refractory state irrespective of risk features

4. Any early relapse

II. Chemotherapy Induction-1: Cytarabine + idarubicin Induction-2: High dose (HD) cytarabine + mitoxantrone Consolidation-1: Cytarabine + idarubicin Consolidation-2: HD cytarabine + etoposide Consolidation-3: HD cytarabine + mitoxantrone Consolidation-4: HD cytarabine + etoposide

III. Allogeneic hematopoietic stem cell transplantation (HSCT) Favorable prognosis group:

chemotherapy only Intermediate prognosis group: chemotherapy or HSCT with reduced intensity conditioning Poor prognosis group: HSCT with myeloablative conditioning

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Patients who were newly diagnosed with de novo AML

• Patients who had recurrent cytogenetic abnormalities of AML even though the bone marrow blast percent is lower than 20%

Exclusion Criteria:

• Acute promyelocytic leukemia

• Down syndrome AML

• Therapy-related AML

• AML developed from myelodysplastic syndrome or other marrow failure syndrome

• Isolated myeloid sarcoma without bone marrow involvement

• Patients who cannot undergo chemotherapy as scheduled due to serious complications at diagnosis

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Cytarabine

• Idarubicin

• Mitoxantrone

• Etoposide

Procedure:
• Hematopoietic stem cell transplantation

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hwasun Hospital	Chonnam
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	St. Mary Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of event free survival		Up to 5 years	Yes
Secondary	Proportion of patients who achieved complete remission		Up to 3 months	Yes