Asia-wide, Multicenter Open-label, Phase II Non-randomised Study Involving Children With Down Syndrome Under 21 Year-old With Newly Diagnosed, Treatment naïve Acute Lymphoblastic Leukemia
Who is this study for? Child to young adult patients with Down Syndrome and Acute Lymphoblastic Leukemia
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 20
Healthy Volunteers: f
View:
• Down syndrome diagnosed clinically or cytogenetically (including Mosaic Down)
• Newly diagnosed ALL according to WHO 2016 classification.
• Age \< 21 years old at time of enrollment.
• ECOG performance status (PS) score of 0-2.
• Written informed consent obtained from legally acceptable representatives.
Locations
Other Locations
Hong Kong Special Administrative Region
Prince of Wales Hospital
RECRUITING
Shatin
Japan
Kagoshima University Hospital
RECRUITING
Kagoshima
Malaysia
University of Malaya Medical Centre
NOT_YET_RECRUITING
Kuala Lumpur
Subang Jaya Medical Centre
NOT_YET_RECRUITING
Subang Jaya
Singapore
KK Women's and Children's Hospital
RECRUITING
Singapore
National University Hospital
RECRUITING
Singapore
Taiwan
Mackay Memorial Hospital
RECRUITING
Taipei
National Taiwan University Children's Hospital
NOT_YET_RECRUITING
Taipei
Chang Gung Memorial Hopsital, Linkou
NOT_YET_RECRUITING
Taoyuan District
Thailand
Siriraj Hospital Mahidol University
RECRUITING
Bangkok
Contact Information
Primary
Allen Yeoh, MBBS
paeyej@nus.edu.sg
(65) 67724406
Time Frame
Start Date: 2017-04-18
Estimated Completion Date: 2033-03-31
Participants
Target number of participants: 60
Treatments
Experimental: SR
Standard Risk (SR) :~CNS 3 or CNS 2 regardless of response OR Time-point #1 (Day 15 induction) Flow MRD ≥ 1% (treatment will not be de-escalated even MRD \<0.01% by TP#2) OR Time-point #2 (Day 1 IDMTX/MP of Consolidation) ≥0.01%~SR strategy:~All SR patient will have to receive two doses of anthracycline and 12 L-asparaginase doses during induction except those who are escalated to SR at time point 2 when MRD ≥0.01%.~During the first year of maintenance phase (48 weeks; 4x12 weeks blocks), cyclophosphamide and cytarabine bolus will be administered at 4 weekly interval.
Experimental: LR
Low Risk (LR):~Time-point #1 (Day 15 induction) Flow MRD \<1% AND Time-point #2 (Day 1 IDMTX/MP of Consolidation) \<0.01% AND CNS 1 only~LR strategy:~For LR patients, one dose of anthracycline and 3 doses of L-asparaginase will be omitted during induction.~Following re-induction I, interim maintenance and additional block of re-induction ie. re-induction II prior to maintenance phase will be omitted for LR patients.
Related Therapeutic Areas
Sponsors
Leads: National Hospital Organization Nagoya Medical Center