Malaysia-Singapore Acute Lymphoblastic Leukemia 2010 Study

• Sponsor: National University Hospital, Singapore (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02894645
• Collaborator: (none)
• Enrollment: 500
• Locations: 4
• Arms: 3
• Patients Per Site: 125

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia (ALL)	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	Phase 4

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ma-Spore ALL 2010 Study
• Study Start Date: Oct 1, 2008
• Anticipated Primary Completion Date: Oct 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Standard Risk (SR)	Drug: Prednisolone; Oral; Drug: Dexamethasone; Oral; Drug: L-Asparaginase; Intramuscular injection; Drug: Vincristine; Intravenous; Drug: Methotrexate; Intrathecal/ Intravenous/ Oral; Drug: Cyclophosphamide; Intravenous; Drug: Cytarabine; Intravenous/ Subcutaneous injection; Drug: 6-Mercaptopurine; Oral; Drug: Thioguanine; Oral
Other: Intermediate Risk (IR)	Drug: Prednisolone; Oral; Drug: Dexamethasone; Oral; Drug: L-Asparaginase; Intramuscular injection; Drug: Vincristine; Intravenous; Drug: Methotrexate; Intrathecal/ Intravenous/ Oral; Drug: Doxorubicin; Intravenous; Drug: Cyclophosphamide; Intravenous; Drug: Cytarabine; Intravenous/ Subcutaneous injection; Drug: 6-Mercaptopurine; Oral; Drug: Thioguanine; Oral
Other: High risk (HR)	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)

Outcome Measures

Primary Outcome Measures

1. Event-free survival (EFS) [5 years]

   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.

2. Overall survival (OS) [5 years]

   OS was determined from diagnosis to time of death from any cause.

3. Minimal residual disease (MRD) measurement [At time point of Day 33, week 8 and week 12]

Secondary Outcome Measures

1. Number of participants with chemotherapy-related adverse events as assessed by CTCAE version 4.0 [Through study completion, an average of 2 years]

2. Dose intensity of chemotherapy during various phases of therapy [Through study completion, an average of 2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Malaya Medical Centre	Kuala Lumpur		Malaysia	59100
2	Subang Jaya Medical Centre	Subang Jaya		Malaysia	47500
3	National University Hospital	Singapore		Singapore	119074
4	KK Women's and Children's Hospital	Singapore		Singapore	229899

Sponsors and Collaborators

• National University Hospital, Singapore

Investigators

• Principal Investigator: Allen Yeoh, MBBS, Ma-spore Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National University Hospital, Singapore
• ClinicalTrials.gov Identifier: NCT02894645
• Other Study ID Numbers: Ma-Spore ALL 2010
• First Posted: Sep 9, 2016
• Last Update Posted: Sep 30, 2016
• Last Verified: Sep 1, 2016

• Additional relevant MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Cytarabine; Dexamethasone; Prednisolone; Cyclophosphamide; Doxorubicin; Methotrexate; Fludarabine; Vincristine; Daunorubicin; Asparaginase; Mercaptopurine; Thioguanine

Study Results

No Results Posted as of Sep 30, 2016