NCT06336395RecruitingPhase 2
Ma-Spore ALL 2020 Study
Ma-Spore ALL-Seq 2020: RNA-Seq and IgH/TCR-Seq to Improve Risk Assignment in Childhood, Adolescent and Young Adult Acute Lymphoblastic Leukaemia
Source: ClinicalTrials.gov · Last updated 28 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 21 Mar 2024
- Start date
- 4 Mar 2020
- Primary completion date
- Mar 2030
- Lead sponsor
- National University Hospital, Singapore
- NCT number
- NCT06336395
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 500
- From 4 Mar 2020 to the primary completion date, Mar 2030
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Doubtful compliance or ability to complete study therapy due to financial, social, familial or geographic reason, or in the judgement of site investigator
Other illness
- Down syndrome with ALL
- History of previous malignancies or this ALL is a second malignancy
- Any serious uncontrolled medical condition or impending end organ dysfunction that would impair the ability of the subject to receive protocol therapy
Lab values
- 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.
- Liver dysfunction with direct bilirubin \> 10x upper normal limit for age.
Other
- T-lineage ALL
- Mixed phenotype acute leukemia (MPAL) or undifferentiated leukemia
- Mature B-cell leukemia/lymphoma
Who the study is looking for
- 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 medullary tissue with confirmation of B-lymphoid differentiation by flow immunophenotyping or histopathologically
- Age \< 41 years of age at enrolment
- Written informed consent obtained from patient or legally acceptable representative (LAR)
Age in the registry: - to 40 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Subang Jaya Medical Centre Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Recruiting |
| University Malaya Medical Centre Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Recruiting |
| KK Women's and Children's Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.