Optimal Treatment Strategy Based on for Pediatric AML

NCT02848183 | Unknown Phase 2

• 1 other identifier: 2015-11-028
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 3

Brief 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)

Conditions

Pediatric Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Rate of event free survival

  Up to 5 years

Secondary Outcomes (1)

• Proportion of patients who achieved complete remission

  Up to 3 months

Study Arms (1)

Pediatric de novo acute myeloid leukemia

EXPERIMENTAL

I. 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 II. 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

Drug: Cytarabine; Drug: Idarubicin; Drug: Mitoxantrone; Drug: Etoposide; Procedure: Hematopoietic stem cell transplantation

Interventions

Cytarabine DRUG

Pediatric de novo acute myeloid leukemia

Idarubicin DRUG

Pediatric de novo acute myeloid leukemia

Mitoxantrone DRUG

Pediatric de novo acute myeloid leukemia

Etoposide DRUG

Pediatric de novo acute myeloid leukemia

Hematopoietic stem cell transplantation PROCEDURE

Pediatric de novo acute myeloid leukemia

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (3)

Chonnam National University Hwasun Hospital

Chonnam, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

St. Mary Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

Cytarabine; Idarubicin; Mitoxantrone; Etoposide; Hematopoietic Stem Cell Transplantation

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Anthraquinones; Anthrones; Anthracenes; Quinones; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Central Study Contacts

Keon Hee Yoo, MD, PhD

CONTACT

82-2-3410-3532; hema2170@skku.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: July 28, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2020
• Last Updated: July 28, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)