A Phase 4 interventional study of Prednisolone and Dexamethasone in Acute Lymphoblastic Leukemia (ALL), sponsored by National University Hospital, Singapore. Status unknown at 4 sites in 2 countries. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2016-09-30.
Sponsored by National University Hospital, Singapore · Phase 4, Interventional, and Treatment
The overall objective of this study is to continue to improve the cure rate of childhood acute lymphoblastic leukemia (ALL) in Singapore and Malaysia in the context of a multi-centre cooperative trial using a risk-stratified therapy based primarily on early response to therapy utilizing a simplified minimal residual disease (MRD-lite) platform.
The study was designed on the premise that a risk classification strategy combining clinical and genetic presenting features with molecular assessment of MRD should reduce both treatment-related toxicities and relapse risk.
The patient will be assigned to one of the 3 risk groups depending on his/her response to the treatment and special laboratory tests. There are no experimental drugs in this study. All the drugs used are standard established treatment for childhood ALL for the last 30 years. The difference in treatment is by changes in the frequency and dose of the chemotherapy drugs.
The overall study treatment lasts for about 2 years.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 500 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →National University Hospital, Singapore is the lead sponsor of 444 studies on the registry; 96 are open to participants now.
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Exclusion Criteria:
Drug: Prednisolone · Drug: Dexamethasone · Drug: L-Asparaginase · Drug: Vincristine · Drug: Methotrexate · Drug: Cyclophosphamide · Drug: Cytarabine · Drug: 6-Mercaptopurine · Drug: Thioguanine
Drug: Prednisolone · Drug: Dexamethasone · Drug: L-Asparaginase · Drug: Vincristine · Drug: Methotrexate · Drug: Doxorubicin · Drug: Cyclophosphamide · Drug: Cytarabine · Drug: 6-Mercaptopurine · Drug: Thioguanine
Drug: Prednisolone · Drug: Dexamethasone · Drug: L-Asparaginase · Drug: Vincristine · Drug: Methotrexate · Drug: Daunorubicin · Drug: Doxorubicin · Drug: Cyclophosphamide · Drug: Cytarabine · Drug: 6-Mercaptopurine · Drug: Thioguanine · Drug: Fludarabine · Drug: Imatinib
Oral
Oral
Intramuscular injection
Intravenous
Intrathecal/ Intravenous/ Oral
Intravenous
Intravenous
Intravenous
Intravenous/ Subcutaneous injection
Oral
Oral
Intravenous
Oral (For BCR-ABL ALL only)
Event-free survival (EFS)
EFS was estimated from time of diagnosis to time of first event or of patient's last follow-up. Failure to achieve complete remission (CR), relapse, death in continuous remission from whatever cause, secondary leukemia and abandonment (absence from scheduled therapy for more than 6 weeks) were considered as events.
Time frame: 5 years
Overall survival (OS)
OS was determined from diagnosis to time of death from any cause.
Time frame: 5 years
Minimal residual disease (MRD) measurement
Time frame: At time point of Day 33, week 8 and week 12
Number of participants with chemotherapy-related adverse events as assessed by CTCAE version 4.0
Time frame: Through study completion, an average of 2 years
Dose intensity of chemotherapy during various phases of therapy
Time frame: Through study completion, an average of 2 years
This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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National University Hospital, Singapore