Status:
RECRUITING
ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016
Lead Sponsor:
National Hospital Organization Nagoya Medical Center
Conditions:
Down Syndrome
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
Up to 20 years
Phase:
PHASE2
Brief 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 bac...
Eligibility Criteria
Inclusion
- 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
- 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:
- 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.
- Ongoing uncontrolled hypertension.
- Ongoing uncontrolled diabetes mellitus.
- Ongoing uncontrolled infection.
- History of congenital or acquired immunodeficiency including HIV infection.
- History of interstitial pneumonia, pulmonary fibrosis, bronchiectasis or severe pulmonary emphysema.
- CNS hemorrhage.
- Psychiatric disorder.
- 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.
Key Trial Info
Start Date :
April 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2033
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03286634
Start Date
April 18 2017
End Date
March 31 2033
Last Update
September 28 2022
Active Locations (10)
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1
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
2
Kagoshima University Hospital
Kagoshima, Japan, 890-8544
3
University of Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
4
Subang Jaya Medical Centre
Subang Jaya, Malaysia, 47500