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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03286634
Other study ID # ASIA-DS-ALL-2016
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date April 18, 2017
Est. completion date March 31, 2033

Study information

Verified date September 2022
Source National Hospital Organization Nagoya Medical Center
Contact Allen Yeoh, MBBS
Phone (65) 67724406
Email paeyej@nus.edu.sg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 31, 2033
Est. primary completion date March 31, 2028
Accepts healthy volunteers No
Gender All
Age group 0 Years to 20 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Second malignancy. - Philadelphia positive ALL. - Mature B-ALL. - Mixed phenotype acute leukemia. - Any previous treatment with cytotoxic chemotherapy excluding treatment for TAM or radiation therapy. Patient pre-treated with short term steroid (< 7 days of duration within last 1 month prior to treatment start) can be enrolled into this study. - Renal dysfunction with creatinine >2x upper limit of normal (ULN). Patients whose creatinine has improved to <2x ULN before treatment commencement can enrol subject to discretion of site PI. - Liver dysfunction with direct bilirubin > 5x ULN. - Any serious uncontrolled medical condition or impending end organ dysfunction that would impair the ability of the subject to receive protocol therapy, including: 1. History of coronary arterial disease, cardiomyopathy, heart failure, arrhythmia (other than sinus arrhythmia) or severe cardiac malformation which with residual abnormalities or requires further major corrective surgery within 2 years. 2. Ongoing uncontrolled hypertension. 3. Ongoing uncontrolled diabetes mellitus. 4. Ongoing uncontrolled infection. 5. History of congenital or acquired immunodeficiency including HIV infection. 6. History of interstitial pneumonia, pulmonary fibrosis, bronchiectasis or severe pulmonary emphysema. 7. CNS hemorrhage. 8. Psychiatric disorder. 9. Other concurrent active neoplasms. - Pregnant or lactating women. - Doubtful compliance or ability to complete study therapy due to financial, social, familial or geographic reason, or in the judgement of site investigator.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Daunorubicin
Given IV
Prednisolone
Given PO or IV
Vincristine
Given IV
Epirubicin
Given IV
E-coli L-asparaginase
Given IM or IV
6-Mercaptopurine
Given PO
Methotrexate
Given IV, PO or IT
Hydrocortisone
Given IT
Cytarabine
Given IV, IT or SC
Cyclophosphamide
Given IV

Locations

Country Name City State
Hong Kong Prince of Wales Hospital Shatin New Territories
Japan Kagoshima University Hospital Kagoshima
Malaysia University of Malaya Medical Centre Kuala Lumpur
Malaysia Subang Jaya Medical Centre Subang Jaya
Singapore KK Women's and Children's Hospital Singapore
Singapore National University Hospital Singapore
Taiwan Mackay Memorial Hospital Taipei
Taiwan National Taiwan University Children's Hospital Taipei
Taiwan Chang Gung Memorial Hopsital, Linkou Taoyuan
Thailand Siriraj Hospital Mahidol University Bangkok

Sponsors (1)

Lead Sponsor Collaborator
National Hospital Organization Nagoya Medical Center

Countries where clinical trial is conducted

Hong Kong,  Japan,  Malaysia,  Singapore,  Taiwan,  Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Event Free Survival Percentage of patients who are event free at 5 years. Up to 5 years
Secondary Overall survival Percentage of patients who survive at 5 years. Up to 5 years
Secondary Disease free survival Percentage of patients who are leukemia free at 5 years. Up to 5 years
Secondary Induction failure Percentage of patients who had failed induction. 5 weeks
Secondary Complete remission rate Percentage of patients who had achieved complete remission at the end of induction. 5 weeks
Secondary Cumulative incidence of relapse Up to 5 years
Secondary Incidence of treatment-related adverse events Incidence of treatment-related infectious and metabolic complications (throughout various phases of study therapy) and secondary neoplasms. Up to 10 years
Secondary Flow MRD at day 15 To assess the prognostic value flow MRD level during induction for DS-ALL. At day 15 of induction therapy
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