Trials / Unknown
UnknownNCT02894645
Malaysia-Singapore Acute Lymphoblastic Leukemia 2010 Study
Ma-Spore ALL 2010 Study
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- Sponsor
- National University Hospital, Singapore · Academic / Other
- Sex
- All
- Age
- 1 Year – 17 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Prednisolone | Oral |
| DRUG | Dexamethasone | Oral |
| DRUG | L-Asparaginase | Intramuscular injection |
| DRUG | Vincristine | Intravenous |
| DRUG | Methotrexate | Intrathecal/ Intravenous/ Oral |
| DRUG | Daunorubicin | Intravenous |
| DRUG | Doxorubicin | Intravenous |
| DRUG | Cyclophosphamide | Intravenous |
| DRUG | Cytarabine | Intravenous/ Subcutaneous injection |
| DRUG | 6-Mercaptopurine | Oral |
| DRUG | Thioguanine | Oral |
| DRUG | Fludarabine | Intravenous |
| DRUG | Imatinib | Oral (For BCR-ABL ALL only) |
Timeline
- Start date
- 2008-10-01
- Primary completion
- 2018-10-01
- First posted
- 2016-09-09
- Last updated
- 2016-09-30
Locations
4 sites across 2 countries: Malaysia, Singapore
Source: ClinicalTrials.gov record NCT02894645. Inclusion in this directory is not an endorsement.