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

Summary

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

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

Interventions

DRUG

Azacitidine

Given IV

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IV, SC, IT

DRUG

Daunorubicin

Given IV

DRUG

Daunorubicin Hydrochloride

Given IV

DRUG

Dexamethasone

Given PO, NG, IV

PROCEDURE

Echocardiography

Undergo ECHO

DRUG

Hydrocortisone Sodium Succinate

Given IT

DRUG

Leucovorin

Given PO, IV

DRUG

Leucovorin Calcium

Given PO, IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Mercaptopurine

Given PO, NG

DRUG

Methotrexate

Given IT, IV, PO

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA scan

DRUG

Pegaspargase

Given IV

DRUG

Prednisolone

Given PO, NG

DRUG

Thioguanine

Given PO, NG

DRUG

Vincristine

Given IV

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Rishi S Kotecha · Children's Oncology Group

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

364 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-01

Primary Completion

2020-09-30

Completion

2024-12-31

FDA Drug

Yes

Countries

• United States
• Australia
• Canada
• Puerto Rico

Study Locations