ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016

Summary

To evaluate the outcome of a prednisolone and low dose methotrexate based protocol in Down syndrome children with ALL (DS-ALL) in an Asia-wide study. The treatment protocol was modified based upon backbone of Taiwan Pediatric Oncology Group (TPOG)-ALL protocol in which risk classification will be guided by level of flow minimal residual disease (MRD) instead.

Conditions

• Down Syndrome
• Acute Lymphoblastic Leukemia
• Childhood Cancer

Interventions

DRUG

Daunorubicin

Given IV

DRUG

Prednisolone

Given PO or IV

DRUG

Vincristine

Given IV

DRUG

Epirubicin

Given IV

DRUG

E-coli L-asparaginase

Given IM or IV

DRUG

6-Mercaptopurine

Given PO

DRUG

Methotrexate

Given IV, PO or IT

DRUG

Hydrocortisone

Given IT

DRUG

Cytarabine

Given IV, IT or SC

DRUG

Cyclophosphamide

Given IV

Sponsors & Collaborators

• National Hospital Organization Nagoya Medical Center

  lead OTHER

Principal Investigators

• Allen Yeoh, MBBS · National University Hospital, Singapore

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

0 Years

Max Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-18

Primary Completion

2028-03-31

Completion

2033-03-31

Countries

• Hong Kong
• Japan
• Malaysia
• Singapore
• Taiwan
• Thailand

Study Locations