search
Back to results

Malaysia-Singapore Acute Lymphoblastic Leukemia 2010 Study

Primary Purpose

Acute Lymphoblastic Leukemia (ALL)

Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Prednisolone
Dexamethasone
L-Asparaginase
Vincristine
Methotrexate
Daunorubicin
Doxorubicin
Cyclophosphamide
Cytarabine
6-Mercaptopurine
Thioguanine
Fludarabine
Imatinib
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia (ALL)

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • University of Malaya Medical CentreRecruiting
  • Subang Jaya Medical CentreRecruiting
  • National University HospitalRecruiting
  • KK Women's and Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Standard Risk (SR)

Intermediate Risk (IR)

High risk (HR)

Arm Description

Outcomes

Primary Outcome Measures

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.
Overall survival (OS)
OS was determined from diagnosis to time of death from any cause.
Minimal residual disease (MRD) measurement

Secondary Outcome Measures

Number of participants with chemotherapy-related adverse events as assessed by CTCAE version 4.0
Dose intensity of chemotherapy during various phases of therapy

Full Information

First Posted
August 25, 2016
Last Updated
September 29, 2016
Sponsor
National University Hospital, Singapore
search

1. Study Identification

Unique Protocol Identification Number
NCT02894645
Brief Title
Malaysia-Singapore Acute Lymphoblastic Leukemia 2010 Study
Official Title
Ma-Spore ALL 2010 Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia (ALL)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Risk (SR)
Arm Type
Other
Arm Title
Intermediate Risk (IR)
Arm Type
Other
Arm Title
High risk (HR)
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
L-Asparaginase
Intervention Description
Intramuscular injection
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
Intravenous
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Intrathecal/ Intravenous/ Oral
Intervention Type
Drug
Intervention Name(s)
Daunorubicin
Intervention Description
Intravenous
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
Intravenous
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Intravenous
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Description
Intravenous/ Subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
6-Mercaptopurine
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Thioguanine
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Intravenous
Intervention Type
Drug
Intervention Name(s)
Imatinib
Intervention Description
Oral (For BCR-ABL ALL only)
Primary Outcome Measure Information:
Title
Event-free survival (EFS)
Description
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
Title
Overall survival (OS)
Description
OS was determined from diagnosis to time of death from any cause.
Time Frame
5 years
Title
Minimal residual disease (MRD) measurement
Time Frame
At time point of Day 33, week 8 and week 12
Secondary Outcome Measure Information:
Title
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
Title
Dose intensity of chemotherapy during various phases of therapy
Time Frame
Through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of non-Burkitt B-lineage ALL 1 to 17 years of age (before 18th birthday) Renal function within normal range for age Liver function within normal range for age Able to participate in the full 2 years of treatment Exclusion Criteria: Age less than one year or age greater than/equals to 18 years Previous treatment with cytotoxic agents or high-dose steroids Mixed phenotype acute leukemia (MPAL) ALL as secondary malignancy Abnormal renal or liver function Doubtful compliance or unable to afford full course of therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Allen Yeoh, MBBS
Phone
(+65) 6772 4406
Email
allen_yeoh@nuhs.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen Yeoh, MBBS
Organizational Affiliation
Ma-spore Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hany Arrifin, MBBS
Phone
+603 7949 6785
Email
hany@ummc.edu.my
Facility Name
Subang Jaya Medical Centre
City
Subang Jaya
ZIP/Postal Code
47500
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hai Peng Lin, MBBS
Email
flslhp@gmail.com
First Name & Middle Initial & Last Name & Degree
Lee Lee Chan, MBBS
Email
drchanleelee@gmail.com
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allen Yeoh, MBBS
Phone
(+65) 6772 4406
Email
allen_yeoh@nuhs.edu.sg
Facility Name
KK Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ah Moy Tan, MBBS
Phone
(+65) 63941039
Email
tan.ah.moy01@singhealth.com.sg

12. IPD Sharing Statement

Citations:
PubMed Identifier
30044693
Citation
Yeoh AEJ, Lu Y, Chin WHN, Chiew EKH, Lim EH, Li Z, Kham SKY, Chan YH, Abdullah WA, Lin HP, Chan LL, Lam JCM, Tan PL, Quah TC, Tan AM, Ariffin H. Intensifying Treatment of Childhood B-Lymphoblastic Leukemia With IKZF1 Deletion Reduces Relapse and Improves Overall Survival: Results of Malaysia-Singapore ALL 2010 Study. J Clin Oncol. 2018 Sep 10;36(26):2726-2735. doi: 10.1200/JCO.2018.78.3050. Epub 2018 Jul 25.
Results Reference
derived

Learn more about this trial

Malaysia-Singapore Acute Lymphoblastic Leukemia 2010 Study

We'll reach out to this number within 24 hrs