Therapeutic Advances in Childhood Leukemia Consortium
Who can join
Adults 1 to 21, any sex, with Lymphoblastic Leukemia, Acute, Childhood or Myelogenous Leukemia, Acute, Childhood. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)Primary· From Day 1 to Day 42 (Cycle 1)
To evaluate the side effects of giving Azacytidine before and during chemotherapy using the standard drugs Fludarabine, Cytarabine, IT Cytarabine (AML patients) and IT methotrexate (ALL patients)
# of patients with DLT
Group
Value
95% CI
Dose 75 mg/m2/Day Azacytidine Diagnosed With AML
0
Dose 75 mg/m2/Day Azacytidine Diagnosed With ALL
0
# of patients without DLT
Group
Value
95% CI
Dose 75 mg/m2/Day Azacytidine Diagnosed With AML
12
Dose 75 mg/m2/Day Azacytidine Diagnosed With ALL
2
# of patients not evaluable
Group
Value
95% CI
Dose 75 mg/m2/Day Azacytidine Diagnosed With AML
1
Dose 75 mg/m2/Day Azacytidine Diagnosed With ALL
0
Disease Response Rate After TreatmentSecondary· Between Days 36-42 of Courses 1 and 2
CR is defined as a bone marrow with \< 5% blast by morphology, no evidence of extramedullary disease, and recovery of peripheral counts (ANC ≥ 1000/μl and platelet counts ≥ 100,000/μl). CR with incomplete count recovery (CRi) was defined as CR without recovery of ANC and/or platelets. Partial response (PR) was defined as complete disappearance of circulating blasts and a decrease of at least 50% of blasts in the bone marrow. Progressive disease (PD) was defined as an increase of at least 25% in the absolute number of bone marrow or circulating blasts, development of new sites of extramedullary
Group
Value
95% CI
Dose 75 mg/m2/Day for AML Patients
6
Dose 75 mg/m2/Dose Azacytidine for ALL Patients
0
Dose 75 mg/m2/Day for AML Patients
1
Dose 75 mg/m2/Dose Azacytidine for ALL Patients
0
Dose 75 mg/m2/Day for AML Patients
1
Dose 75 mg/m2/Dose Azacytidine for ALL Patients
1
Dose 75 mg/m2/Day for AML Patients
1
Dose 75 mg/m2/Dose Azacytidine for ALL Patients
1
Adverse events — posted to ClinicalTrials.gov
Time frame: From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
AML Cohort: 75 mg/m2/Day
Serious: 5/13 (38%)
Deaths: 0/13
ALL Cohort: 75 mg/m2/Day
Serious: 1/2 (50%)
Deaths: 0/2
Serious adverse events (6 terms)
Reaction
System
AML Cohort: 75 mg/m2/Day
ALL Cohort: 75 mg/m2/Day
Febrile neutropenia
Blood and lymphatic system disorders
—
—
Infections and infestations - Other, specify
Infections and infestations
—
—
Fever
General disorders
—
—
Hypokalemia
Metabolism and nutrition disorders
—
—
Hypotension
Vascular disorders
—
—
Sepsis
Infections and infestations
—
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Other adverse events (102 terms — click to expand)
This is a Phase I study with a conditional cohort expansion phase to evaluate the feasibility of, and to obtain preliminary efficacy data about, pretreatment with Azacytidine (AZA) for 5 days followed by fludarabine/cytarabine chemotherapy regimen in pediatric acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) patients who are refractory to primary treatment or who relapsed.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05355051 — A Phase II Study of the Combination of Azacitidine and Pembrolizumab for Patients Relapsed/Refractory Hodgkin's Lymphoma
· Phase 2
· recruiting
NCT04648826 — Aerosolized Azacytidine as Epigenetic Priming for Bintrafusp Alfa-Mediated Immune Checkpoint Blockade in Patients With U
· Phase 1, PHASE2
· withdrawn
NCT04747236 — Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL
· Phase 2
· recruiting
NCT03873311 — Azacytidine + HAG Regimen vs. Azacytidine for Elderly Patients With Newly Diagnosed Myeloid Malignancy
· Phase 4
· unknown
NCT02196857 — Sorafenib Plus 5-Azacitidine Initial Therapy of Patients With Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic
· Phase 2
· completed
Other recruiting trials for Lymphoblastic Leukemia, Acute, Childhood
NCT05038696 — ALaCART-B: Acute Leukemia and Chimeric Antigen Receptor-T Cell Therapy for B-lymphoblastic Leukemia.
· Phase 1
· recruiting
NCT03817320 — PO Ixazomib in Combination With Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymph
· Phase 1, PHASE2
· active not recruiting
Other Therapeutic Advances in Childhood Leukemia Consortium trials
Trials by the same sponsor.
NCT05476770 — Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies
· Phase 1
· recruiting
NCT03825367 — Nivolumab in Combination With 5-azacytidine in Childhood Relapsed/Refractory AML
· Phase 1, PHASE2
· unknown
NCT03817320 — PO Ixazomib in Combination With Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymph
· Phase 1, PHASE2
· active not recruiting
NCT03263936 — Epigenetic Reprogramming in Relapse/Refractory AML
· Phase 1
· completed
NCT02879643 — Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With UK ALL R3 Induction Chemotherapy
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Therapeutic Advances in Childhood Leukemia Consortium
Last refreshed: 9 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01861002.