Malaysia-Singapore Acute Lymphoblastic Leukemia 2010 Study

Acute Lymphoblastic Leukemia (ALL) Clinical Trial

Official title:

Ma-Spore ALL 2010 Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02894645
• Other study ID #: Ma-Spore ALL 2010
• Status: Recruiting
• Phase: Phase 4
• First received: August 25, 2016
• Last updated: September 29, 2016
• Start date: October 2008

Study information

• Verified date: September 2016
• Source: National University Hospital, Singapore
• Contact: Allen Yeoh, MBBS
• Phone: (+65) 6772 4406
• Email: allen_yeoh[@]nuhs.edu.sg
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 17 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia (ALL)
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Prednisolone
Oral
• Dexamethasone
Oral
• L-Asparaginase
Intramuscular injection
• Vincristine
Intravenous
• Methotrexate
Intrathecal/ Intravenous/ Oral
• Daunorubicin
Intravenous
• Doxorubicin
Intravenous
• Cyclophosphamide
Intravenous
• Cytarabine
Intravenous/ Subcutaneous injection
• 6-Mercaptopurine
Oral
• Thioguanine
Oral
• Fludarabine
Intravenous
• Imatinib
Oral (For BCR-ABL ALL only)

Locations

Country	Name	City	State
Malaysia	University of Malaya Medical Centre	Kuala Lumpur
Malaysia	Subang Jaya Medical Centre	Subang Jaya
Singapore	KK Women's and Children's Hospital	Singapore
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Countries where clinical trial is conducted

Malaysia,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years	No
Primary	Overall survival (OS)	OS was determined from diagnosis to time of death from any cause.	5 years	No
Primary	Minimal residual disease (MRD) measurement		At time point of Day 33, week 8 and week 12	No
Secondary	Number of participants with chemotherapy-related adverse events as assessed by CTCAE version 4.0		Through study completion, an average of 2 years	Yes
Secondary	Dose intensity of chemotherapy during various phases of therapy		Through study completion, an average of 2 years	Yes