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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Kagoshima University Hospital
Kagoshima, Japan
University of Malaya Medical Centre
Kuala Lumpur, Malaysia
Subang Jaya Medical Centre
Event Free Survival
Percentage of patients who are event free at 5 years.
Time frame: Up to 5 years
Overall survival
Percentage of patients who survive at 5 years.
Time frame: Up to 5 years
Disease free survival
Percentage of patients who are leukemia free at 5 years.
Time frame: Up to 5 years
Induction failure
Percentage of patients who had failed induction.
Time frame: 5 weeks
Complete remission rate
Percentage of patients who had achieved complete remission at the end of induction.
Time frame: 5 weeks
Cumulative incidence of relapse
Time frame: Up to 5 years
Incidence of treatment-related adverse events
Incidence of treatment-related infectious and metabolic complications (throughout various phases of study therapy) and secondary neoplasms.
Time frame: Up to 10 years
Flow MRD at day 15
To assess the prognostic value flow MRD level during induction for DS-ALL.
Time frame: At day 15 of induction therapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Given IV
Given IM or IV
Given PO
Given IV, PO or IT
Given IT
Given IV, IT or SC
Given IV
Subang Jaya, Malaysia
National University Hospital
Singapore, Singapore
KK Women's and Children's Hospital
Singapore, Singapore
National Taiwan University Children's Hospital
Taipei, Taiwan
Mackay Memorial Hospital
Taipei, Taiwan
Chang Gung Memorial Hopsital, Linkou
Taoyuan, Taiwan
Siriraj Hospital Mahidol University
Bangkok, Thailand