Last updated: March 21, 2024
Sponsor: National University Hospital, Singapore
Overall Status: Active - Recruiting
Phase
2
Condition
Leukemia
Treatment
Dexamethasone
Cyclophosphamide
Pegylated asparaginase
Clinical Study ID
NCT06336395
2019/00888
Ages < 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Has been diagnosed with B-lineage ALL as evidenced by:
- BMA blasts > 20% AND
- Leukemic process in the bone marrow, peripheral blood or any extra medullarytissue with confirmation of B-lymphoid differentiation by flow immunophenotypingor histopathologically
- Age < 41 years of age at enrolment
- Written informed consent obtained from patient or legally acceptable representative (LAR)
Exclusion
Exclusion Criteria:
- T-lineage ALL
- Down syndrome with ALL
- History of previous malignancies or this ALL is a second malignancy
- Mixed phenotype acute leukemia (MPAL) or undifferentiated leukemia
- Mature B-cell leukemia/lymphoma
- Any previous cytotoxic therapy (chemotherapy/radiotherapy/immunotherapy). Patientpre-treated with short term steroid (< 7 days of duration within last 1 month prior toALL treatment start) may be enrolled after discussion and written approval from PI.These patients should be treated on at least intermediate arm.
- Persistent renal dysfunction with creatinine more than upper limit of normal for agebefore start of induction therapy. Patients requiring temporary dialysis withoutpersistent renal dysfunction can qualify.
- Liver dysfunction with direct bilirubin > 10x upper normal limit for age.
- Any serious uncontrolled medical condition or impending end organ dysfunction thatwould impair the ability of the subject to receive protocol therapy
- Doubtful compliance or ability to complete study therapy due to financial, social,familial or geographic reason, or in the judgement of site investigator
Study Design
Total Participants: 500
Treatment Group(s): 16
Primary Treatment: Dexamethasone
Phase: 2
Study Start date:
March 04, 2020
Estimated Completion Date:
March 31, 2030
Study Description
Connect with a study center
Subang Jaya Medical Centre
Kuala Lumpur, 47500
MalaysiaActive - Recruiting
University Malaya Medical Centre
Kuala Lumpur, 59100
MalaysiaActive - Recruiting
KK Women's and Children's Hospital
Singapore, 229899
SingaporeActive - Recruiting
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