A Phase 2 interventional study of Daunorubicin and Prednisolone in Down Syndrome, Acute Lymphoblastic Leukemia and Childhood Cancer, sponsored by National Hospital Organization Nagoya Medical Center. Active, not recruiting at 10 sites in 6 countries. Open to participants aged 0 Years to 20 Years. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by National Hospital Organization Nagoya Medical Center · Phase 2, Interventional, and Treatment
To evaluate the outcome of a prednisolone and low dose methotrexate based protocol in Down syndrome children with ALL (DS-ALL) in an Asia-wide study. The treatment protocol was modified based upon backbone of Taiwan Pediatric Oncology Group (TPOG)-ALL protocol in which risk classification will be guided by level of flow minimal residual disease (MRD) instead.
438 studies on the registry are indexed under Down Syndrome; 99 are open to participants now.
This study's planned enrollment of 60 is above the median of 37 across 286 interventional studies indexed under Down Syndrome.
Browse Down Syndrome studies →National Hospital Organization Nagoya Medical Center is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any serious uncontrolled medical condition or impending end organ dysfunction that would impair the ability of the subject to receive protocol therapy, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard Risk (SR) : CNS 3 or CNS 2 regardless of response OR Time-point #1 (Day 15 induction) Flow MRD ≥ 1% (treatment will not be de-escalated even MRD \<0.01% by TP#2) OR Time-point #2 (Day 1 IDMTX/MP of Consolidation) ≥0.01% SR strategy: All SR patient will have to receive two doses of anthracycline and 12 L-asparaginase doses during induction except those who are escalated to SR at time point 2 when MRD ≥0.01%. During the first year of maintenance phase (48 weeks; 4x12 weeks blocks), cyclophosphamide and cytarabine bolus will be administered at 4 weekly interval.
Drug: Daunorubicin · Drug: Prednisolone · Drug: Vincristine · Drug: Epirubicin · Drug: E-coli L-asparaginase · Drug: 6-Mercaptopurine · Drug: Methotrexate · Drug: Hydrocortisone · Drug: Cytarabine · Drug: Cyclophosphamide
Low Risk (LR): Time-point #1 (Day 15 induction) Flow MRD \<1% AND Time-point #2 (Day 1 IDMTX/MP of Consolidation) \<0.01% AND CNS 1 only LR strategy: For LR patients, one dose of anthracycline and 3 doses of L-asparaginase will be omitted during induction. Following re-induction I, interim maintenance and additional block of re-induction ie. re-induction II prior to maintenance phase will be omitted for LR patients.
Drug: Daunorubicin · Drug: Prednisolone · Drug: Vincristine · Drug: Epirubicin · Drug: E-coli L-asparaginase · Drug: 6-Mercaptopurine · Drug: Methotrexate · Drug: Hydrocortisone
Given IV
Also known as: DNR
Given PO or IV
Also known as: Pred
Given IV
Also known as: VCR
Given IV
Also known as: EPI
Given IM or IV
Also known as: E-coli L-Asp
Given PO
Also known as: 6-MP
Given IV, PO or IT
Also known as: MTX
Given IT
Given IV, IT or SC
Also known as: Ara-C
Given IV
Also known as: Cy
Event Free Survival
Percentage of patients who are event free at 5 years.
Time frame: Up to 5 years
Overall survival
Percentage of patients who survive at 5 years.
Time frame: Up to 5 years
Disease free survival
Percentage of patients who are leukemia free at 5 years.
Time frame: Up to 5 years
Induction failure
Percentage of patients who had failed induction.
Time frame: 5 weeks
Complete remission rate
Percentage of patients who had achieved complete remission at the end of induction.
Time frame: 5 weeks
Cumulative incidence of relapse
Time frame: Up to 5 years
Incidence of treatment-related adverse events
Incidence of treatment-related infectious and metabolic complications (throughout various phases of study therapy) and secondary neoplasms.
Time frame: Up to 10 years
Flow MRD at day 15
To assess the prognostic value flow MRD level during induction for DS-ALL.
Time frame: At day 15 of induction therapy
Started Apr 2017 (actual). Primary completion is estimated for Mar 2028, 131 months after the start.
Of 21 phase 2 interventional studies under Down Syndrome, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 61. This study's planned 131 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Cytarabine · Cyclophosphamide
National Hospital Organization Nagoya Medical Center