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B Lymphoblastic LeukemiaPhase 2NCT06336395

Ma-Spore ALL 2020 Study

A Phase 2 study testing Prednisolone, Dexamethasone and Vincristine in people with B Lymphoblastic Leukemia, run by National University Hospital, Singapore at 3 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 40 years
Conditions the study is for
B Lymphoblastic Leukemia
What is being tested?
Prednisolone, Dexamethasone and Vincristine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
3 sitesin 2 countries
Study dates
4 Mar 2020to Mar 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 40 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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)

Who cannot join

  • 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). 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.
Show all 10Show fewer
  • 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.
  • Any serious uncontrolled medical condition or impending end organ dysfunction that would 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

Trial locations and contacts

3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Allen Eng Juh Yeoh, MBBS contact

+65 67724406

paeyej@nus.edu.sg

3 sites in 2 countries

Malaysia2 sites, 2 recruiting

  • Subang Jaya Medical Centre

    Kuala Lumpur, 47500

    Hai Peng Lin, +603 56391621, flslhp@gmail.com

    Lee Lee Chan, MBBS

    Recruiting

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

    Hany Arrifin, MBBS, +603 79492065, hany@ummc.edu.my

    Recruiting

Other trials in Malaysia

Singapore1 site, 1 recruiting

  • KK Women's and Children's Hospital

    Singapore, 229899

    Ah Moy Tan, MBBS, +65 63941039, tan.ah.moy01@singhealth.com.sg

    Recruiting

Other trials in Singapore

About this study

Official title: Ma-Spore ALL-Seq 2020: RNA-Seq and IgH/TCR-Seq to Improve Risk Assignment in Childhood, Adolescent and Young Adult Acute Lymphoblastic Leukaemia

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.

Read the 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.

Being tested
Prednisolone, Dexamethasone, Vincristine, Methotrexate, L-Asparaginase

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrednisoloneDrug

    Oral

  • DexamethasoneDrug

    Oral

  • VincristineDrug

    Intravenous

  • MethotrexateDrug

    Oral/ intrathecal/intravenous/subcutaneous

  • L-AsparaginaseDrug

    Intramuscular

  • Pegylated asparaginaseDrug

    Intravenous

  • ErwinaseDrug

    Optional for those allergic to E.coli/PEG L-asparaginase (intravenous)

  • DasatinibDrug

    Indicated only for ALL with BCR::ABL1 /BCR::ABL1-like/ tyrosine kinase fusion positive (oral)

  • ImatinibDrug

    Indicated only for ALL with BCR::ABL1 /BCR::ABL1-like/ tyrosine kinase fusion positive (oral)

  • CyclophosphamideDrug

    Intravenous

  • CytarabineDrug

    Subcutaneous/ Intravenous

  • MercaptopurineDrug

    Oral

  • ThioguanineDrug

    Oral

  • RituximabDrug

    Intravenous

  • DoxorubicinDrug

    Intravenous

  • FludarabineDrug

    Intravenous

Study groups in NCT06336395
Study groupRoleWhat they receive
Standard risk (SR)Experimental1. No anthracycline throughout the treatment. 2. CNS consolidation using "Capizzi type" low dose methotrexate (LDMTX) x 2 courses to replace pre-existing high dose methotrexate (HDMTX) 2.5g #3/4
Receives: Drug: Prednisolone; Drug: Dexamethasone; Drug: Vincristine; Drug: Methotrexate; Drug: L-Asparaginase; Drug: Pegylated asparaginase; Drug: Erwinase; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Mercaptopurine; Drug: Thioguanine
Intermediate risk (IR)ExperimentalThose with CD20 ≥ 20% expression on diagnostic blasts by flow immunophenotyping will receive additional dose of rituximab on day 1 of each delayed intensification (DI) phases: phase III (2 courses) and V (1 course) for total 3 infusions
Receives: Drug: Prednisolone; Drug: Dexamethasone; Drug: Vincristine; Drug: Methotrexate; Drug: L-Asparaginase; Drug: Pegylated asparaginase; Drug: Erwinase; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Mercaptopurine; Drug: Thioguanine; Drug: Rituximab; Drug: Doxorubicin
High risk (HR)ExperimentalProvisional HR patients will be offered CAR-T cell immunotherapy or HSCT
Receives: Drug: Prednisolone; Drug: Dexamethasone; Drug: Vincristine; Drug: Methotrexate; Drug: L-Asparaginase; Drug: Pegylated asparaginase; Drug: Erwinase; Drug: Dasatinib; Drug: Imatinib; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Mercaptopurine; Drug: Thioguanine; Drug: Doxorubicin; Drug: Fludarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    OS is calculated from the date of diagnosis to the date of last follow-up or any death

    Measured: 5 years from diagnosis

Secondary outcomes (1)

  1. Event free survival (EFS)

    EFS will be calculated from the date of diagnosis of ALL to date of last follow-up or to the first event, including relapse, resistant disease, second malignancy and death

    Measured: 5 years from diagnosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2024
  2. Study start4 Mar 2020
  3. Primary completionMar 2030 (estimated)
  4. Study completionMar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06336395
Sponsor's protocol ID
2019/00888
Other IDs
2019
Status last verified
Mar 2024
First submitted
21 Mar 2024
Last updated
28 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Prednisolone, Dexamethasone and Vincristine in people with B Lymphoblastic Leukemia, run by National University Hospital, Singapore at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Malaysia, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Allen Eng Juh Yeoh, MBBS (+65 67724406, paeyej@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: 5 years from diagnosis). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06336395.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.

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