Trial Title:
Ma-Spore ALL 2020 Study
NCT ID:
NCT06336395
Condition:
B Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Cytarabine
Dexamethasone
Prednisolone
Cyclophosphamide
Rituximab
Doxorubicin
Methotrexate
Fludarabine
Vincristine
Asparaginase
Dasatinib
Mercaptopurine
Thioguanine
Pegaspargase
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Prednisolone
Description:
Oral
Arm group label:
High risk (HR)
Arm group label:
Intermediate risk (IR)
Arm group label:
Standard risk (SR)
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
Oral
Arm group label:
High risk (HR)
Arm group label:
Intermediate risk (IR)
Arm group label:
Standard risk (SR)
Intervention type:
Drug
Intervention name:
Vincristine
Description:
Intravenous
Arm group label:
High risk (HR)
Arm group label:
Intermediate risk (IR)
Arm group label:
Standard risk (SR)
Intervention type:
Drug
Intervention name:
Methotrexate
Description:
Oral/ intrathecal/intravenous/subcutaneous
Arm group label:
High risk (HR)
Arm group label:
Intermediate risk (IR)
Arm group label:
Standard risk (SR)
Intervention type:
Drug
Intervention name:
L-Asparaginase
Description:
Intramuscular
Arm group label:
High risk (HR)
Arm group label:
Intermediate risk (IR)
Arm group label:
Standard risk (SR)
Intervention type:
Drug
Intervention name:
Pegylated asparaginase
Description:
Intravenous
Arm group label:
High risk (HR)
Arm group label:
Intermediate risk (IR)
Arm group label:
Standard risk (SR)
Intervention type:
Drug
Intervention name:
Erwinase
Description:
Optional for those allergic to E.coli/PEG L-asparaginase (intravenous)
Arm group label:
High risk (HR)
Arm group label:
Intermediate risk (IR)
Arm group label:
Standard risk (SR)
Intervention type:
Drug
Intervention name:
Dasatinib
Description:
Indicated only for ALL with BCR::ABL1 /BCR::ABL1-like/ tyrosine kinase fusion positive
(oral)
Arm group label:
High risk (HR)
Intervention type:
Drug
Intervention name:
Imatinib
Description:
Indicated only for ALL with BCR::ABL1 /BCR::ABL1-like/ tyrosine kinase fusion positive
(oral)
Arm group label:
High risk (HR)
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Intravenous
Arm group label:
High risk (HR)
Arm group label:
Intermediate risk (IR)
Arm group label:
Standard risk (SR)
Intervention type:
Drug
Intervention name:
Cytarabine
Description:
Subcutaneous/ Intravenous
Arm group label:
High risk (HR)
Arm group label:
Intermediate risk (IR)
Arm group label:
Standard risk (SR)
Intervention type:
Drug
Intervention name:
Mercaptopurine
Description:
Oral
Arm group label:
High risk (HR)
Arm group label:
Intermediate risk (IR)
Arm group label:
Standard risk (SR)
Intervention type:
Drug
Intervention name:
Thioguanine
Description:
Oral
Arm group label:
High risk (HR)
Arm group label:
Intermediate risk (IR)
Arm group label:
Standard risk (SR)
Intervention type:
Drug
Intervention name:
Rituximab
Description:
Intravenous
Arm group label:
Intermediate risk (IR)
Intervention type:
Drug
Intervention name:
Doxorubicin
Description:
Intravenous
Arm group label:
High risk (HR)
Arm group label:
Intermediate risk (IR)
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Intravenous
Arm group label:
High risk (HR)
Summary:
The primary objective of this trial is to improve the overall survival rate of children
and young adult with B-lineage acute lymphoblastic leukemia (B-ALL) in Singapore and
Malaysia in the context of a multicenter cooperative trial using a risk-stratified
therapy.
Detailed description:
This is a multicenter open-label phase II study involving children and young adult (< 41
years old) who are newly diagnosed with B-ALL and treatment naïve. There will be 3
parallel cohorts whose risk to be stratified based upon leukemia genetics profiles and
patient's treatment response:
1. Standard Risk (SR)
2. Intermediate Risk (IR)
3. High Risk (HR)
All drugs being used are commercially available chemotherapy drugs. There will be no
novel chemotherapeutic agent without marketing authorization being tested in this trial.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Has been diagnosed with B-lineage ALL as evidenced by:
1. BMA blasts > 20% AND
2. Leukemic process in the bone marrow, peripheral blood or any extra medullary
tissue with confirmation of B-lymphoid differentiation by flow
immunophenotyping or histopathologically
2. Age < 41 years of age at enrolment
3. Written informed consent obtained from patient or legally acceptable representative
(LAR)
Exclusion Criteria:
1. T-lineage ALL
2. Down syndrome with ALL
3. History of previous malignancies or this ALL is a second malignancy
4. Mixed phenotype acute leukemia (MPAL) or undifferentiated leukemia
5. Mature B-cell leukemia/lymphoma
6. Any previous cytotoxic therapy (chemotherapy/radiotherapy/immunotherapy). Patient
pre-treated with short term steroid (< 7 days of duration within last 1 month prior
to ALL treatment start) may be enrolled after discussion and written approval from
PI. These patients should be treated on at least intermediate arm.
7. Persistent renal dysfunction with creatinine more than upper limit of normal for age
before start of induction therapy. Patients requiring temporary dialysis without
persistent renal dysfunction can qualify.
8. Liver dysfunction with direct bilirubin > 10x upper normal limit for age.
9. Any serious uncontrolled medical condition or impending end organ dysfunction that
would impair the ability of the subject to receive protocol therapy
10. Doubtful compliance or ability to complete study therapy due to financial, social,
familial or geographic reason, or in the judgement of site investigator
Gender:
All
Minimum age:
N/A
Maximum age:
40 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Subang Jaya Medical Centre
Address:
City:
Kuala Lumpur
Zip:
47500
Country:
Malaysia
Status:
Recruiting
Contact:
Last name:
Hai Peng Lin
Phone:
+603 56391621
Email:
flslhp@gmail.com
Investigator:
Last name:
Lee Lee Chan, MBBS
Email:
Sub-Investigator
Facility:
Name:
University Malaya Medical Centre
Address:
City:
Kuala Lumpur
Zip:
59100
Country:
Malaysia
Status:
Recruiting
Contact:
Last name:
Hany Arrifin, MBBS
Phone:
+603 79492065
Email:
hany@ummc.edu.my
Facility:
Name:
KK Women's and Children's Hospital
Address:
City:
Singapore
Zip:
229899
Country:
Singapore
Status:
Recruiting
Contact:
Last name:
Ah Moy Tan, MBBS
Phone:
+65 63941039
Email:
tan.ah.moy01@singhealth.com.sg
Start date:
March 4, 2020
Completion date:
March 2030
Lead sponsor:
Agency:
National University Hospital, Singapore
Agency class:
Other
Source:
National University Hospital, Singapore
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06336395