At a glance
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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
In Brief
A Phase 2 clinical trial evaluating Azacitidine, Biospecimen Collection, and 19 other interventions for Acute Leukemia of Ambiguous Lineage and 2 related conditions. Completed, enrolled 78 participants across 170 sites in 4 countries.
Detailed 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.
Study Details
Timeline
Interventions
Given IV
Undergo blood sample collection
Undergo CT scan
Given IV
Given IV, SC, IT
Given IV
Given IV
Given PO, NG, IV
Undergo ECHO
Given IT
Given PO, IV
Given PO, IV
Undergo MRI
Given PO, NG
Given IT, IV, PO
Undergo MUGA scan
Given IV
Given PO, NG
Given PO, NG
Given IV
Given IV