Malaysia-Singapore Acute Lymphoblastic Leukemia 2010 Study

National University Health System (NUHS)

Status and phase: Unknown; Phase 4

Conditions: Acute Lymphoblastic Leukemia (ALL)

Treatments: Drug: Prednisolone; Drug: Daunorubicin; Drug: Dexamethasone; Drug: Methotrexate; Drug: Vincristine; Drug: Thioguanine; Drug: L-Asparaginase; Drug: Fludarabine; Drug: 6-Mercaptopurine; Drug: Doxorubicin; Drug: Imatinib; Drug: Cytarabine; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT02894645

Ma-Spore ALL 2010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Confirmed diagnosis of non-Burkitt B-lineage ALL
2. 1 to 17 years of age (before 18th birthday)
3. Renal function within normal range for age
4. Liver function within normal range for age
5. Able to participate in the full 2 years of treatment

Exclusion criteria

1. Age less than one year or age greater than/equals to 18 years
2. Previous treatment with cytotoxic agents or high-dose steroids
3. Mixed phenotype acute leukemia (MPAL)
4. ALL as secondary malignancy
5. Abnormal renal or liver function
6. Doubtful compliance or unable to afford full course of therapy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

500 participants in 3 patient groups

Standard Risk (SR)

Other group

Treatment:

Drug: Thioguanine

Drug: Vincristine

Drug: Methotrexate

Drug: L-Asparaginase

Drug: 6-Mercaptopurine

Drug: Cytarabine

Drug: Cyclophosphamide

Drug: Prednisolone

Drug: Dexamethasone

Intermediate Risk (IR)

Other group

Treatment:

Drug: Thioguanine

Drug: Vincristine

Drug: Doxorubicin

Drug: Methotrexate

Drug: L-Asparaginase

Drug: 6-Mercaptopurine

Drug: Cytarabine

Drug: Cyclophosphamide

Drug: Prednisolone

Drug: Dexamethasone

High risk (HR)

Other group

Treatment:

Drug: Fludarabine

Drug: Thioguanine

Drug: Vincristine

Drug: Doxorubicin

Drug: Methotrexate

Drug: L-Asparaginase

Drug: 6-Mercaptopurine

Drug: Cytarabine

Drug: Cyclophosphamide

Drug: Prednisolone

Drug: Imatinib

Drug: Daunorubicin

Drug: Dexamethasone