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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

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