Clinical trial · Interventional
Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement
A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (IND# 133688, NSC# 102816) to Chemotherapy in Infants With Acute Lymphoblastic Leukemia (ALL) and KMT2A(MLL) Gene Rearrangement
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This pilot phase II trial studies the side effects of azacitidine and combination chemotherapy in infants with acute lymphoblastic leukemia and KMT2A gene rearrangement. Drugs used in chemotherapy, such as methotrexate, prednisolone, daunorubicin hydrochloride, cytarabine, dexamethasone, vincristine sulfate, pegaspargase, hydrocortisone sodium succinate, azacitidine, cyclophosphamide, mercaptopurine, leucovorin calcium, and thioguanine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug may kill more cancer cells.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia of Ambiguous Lineage | Acute Leukemia of Ambiguous Lineage | CURATED_BROADER | 0.80 |
| B Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
| Mixed Phenotype Acute Leukemia | Mixed Phenotype Acute Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (21)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Daunorubicin | Drug | Daunorubicin | ALIAS |
| Daunorubicin Hydrochloride | Drug | Daunorubicin | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (azacitidine, combination chemotherapy)
- description
- See Detailed Description
- interventionNames
- Drug: Azacitidine
- Procedure: Biospecimen Collection
- Procedure: Computed Tomography
- Drug: Cyclophosphamide
- Drug: Cytarabine
- Drug: Daunorubicin
- Drug: Daunorubicin Hydrochloride
- Drug: Dexamethasone
- Procedure: Echocardiography
- Drug: Hydrocortisone Sodium Succinate
- Drug: Leucovorin
- Drug: Leucovorin Calcium
- Procedure: Magnetic Resonance Imaging
- Drug: Mercaptopurine
- Drug: Methotrexate
- Procedure: Multigated Acquisition Scan
- Drug: Pegaspargase
- Drug: Prednisolone
- Drug: Thioguanine
- Drug: Vincristine
- Drug: Vincristine Sulfate
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 364 Days
Show eligibility criteria text
Inclusion Criteria: * Infants must be \> 36 weeks gestational age at the time of enrollment * Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization \[WHO\] classification) (also termed B-precursor acute lymphoblastic leukemia) or acute leukemia of ambiguous lineage (ALUL), which includes mixed phenotype acute leukemia (MPAL); for patients with ALUL, the morphology and immunophenotype must be at least 50% B lymphoblastic * Central nervous system (CNS) status must be determined based on a sample obtained prior to the administration of any systemic or intrathecal chemotherapy, with the exception of steroid pretreatment Exclusion Criteria: * Patients with known absence of KMT2A-rearrangement leukemia prior to enrollment * Patients with Down syndrome * Patients with secondary B acute lymphoblastic leukemia (B-ALL) that developed after treatment of a prior malignancy with cytotoxic chemotherapy * With the exception of steroid pretreatment or the administration of intrathecal methotrexate or intrathecal cytarabine, receipt of any other prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL15P1
References
Publications (1)
- DERIVEDGuest EM, Kairalla JA, Devidas M, Hibbitts E, Carroll AJ, Heerema NA, Kubaney HR, August MA, Ramesh S, Yoo B, Farooqi MS, Pauly MG, Wechsler DS, Miles RR, Reid JM, Kihei CD, Gore L, Raetz EA, Hunger SP, Loh ML, Brown PA. Azacitidine as epigenetic priming for chemotherapy is safe and well-tolerated in infants with newly diagnosed KMT2A-rearranged acute lymphoblastic leukemia: Children's Oncology Group trial AALL15P1. Haematologica. 2024 Dec 1;109(12):3918-3927. doi: 10.3324/haematol.2024.285158. PMID 38867582