# Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement

> **NCT02828358** · PHASE2 · COMPLETED · sponsor: **National Cancer Institute (NCI)** · enrollment: 78 (actual)

## Conditions studied

- Acute Leukemia of Ambiguous Lineage
- B Acute Lymphoblastic Leukemia
- Mixed Phenotype Acute Leukemia

## Interventions

- **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

## Key facts

- **NCT ID:** NCT02828358
- **Lead sponsor:** National Cancer Institute (NCI)
- **Sponsor class:** NIH
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2017-04-01
- **Primary completion:** 2020-09-30
- **Final completion:** 2024-12-31
- **Target enrollment:** 78 (ACTUAL)
- **Last updated:** 2025-02-27


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02828358

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02828358, "Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement". Retrieved via AI Analytics 2026-07-05 from https://api.ai-analytics.org/clinical/NCT02828358. Licensed CC0.

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