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Malaysia-Singapore Acute Lymphoblastic Leukemia 2010 Study

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ClinicalTrials.gov Identifier: NCT02894645
Recruitment Status : Unknown
Verified September 2016 by National University Hospital, Singapore.
Recruitment status was:  Recruiting
First Posted : September 9, 2016
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2008
Estimated Primary Completion Date : October 2018


Arm Intervention/treatment
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

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

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)




Primary Outcome Measures :
  1. Event-free survival (EFS) [ Time Frame: 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) [ Time Frame: 5 years ]
    OS was determined from diagnosis to time of death from any cause.

  3. Minimal residual disease (MRD) measurement [ Time Frame: 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 [ Time Frame: Through study completion, an average of 2 years ]
  2. Dose intensity of chemotherapy during various phases of therapy [ Time Frame: Through study completion, an average of 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02894645


Contacts
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Contact: Allen Yeoh, MBBS (+65) 6772 4406 allen_yeoh@nuhs.edu.sg

Locations
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Malaysia
University of Malaya Medical Centre Recruiting
Kuala Lumpur, Malaysia, 59100
Contact: Hany Arrifin, MBBS    +603 7949 6785    hany@ummc.edu.my   
Subang Jaya Medical Centre Recruiting
Subang Jaya, Malaysia, 47500
Contact: Hai Peng Lin, MBBS       flslhp@gmail.com   
Contact: Lee Lee Chan, MBBS       drchanleelee@gmail.com   
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119074
Contact: Allen Yeoh, MBBS    (+65) 6772 4406    allen_yeoh@nuhs.edu.sg   
KK Women's and Children's Hospital Recruiting
Singapore, Singapore, 229899
Contact: Ah Moy Tan, MBBS    (+65) 63941039    tan.ah.moy01@singhealth.com.sg   
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
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Principal Investigator: Allen Yeoh, MBBS Ma-spore Group

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT02894645     History of Changes
Other Study ID Numbers: Ma-Spore ALL 2010
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Dexamethasone
Prednisolone
Cyclophosphamide
Doxorubicin
Methotrexate
Fludarabine
Vincristine
Daunorubicin
Asparaginase
Mercaptopurine
Thioguanine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists