A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (NSC# 102816) to Chemotherapy in Infants With Acute Lymphoblastic Leukemia (ALL) and KMT2A(MLL) Gene Rearrangement


This pilot phase II trial studies the side effects of azacitidine and combination chemotherapy in infants with acute lymphoblastic leukemia and KMT2A gene rearrangement.


The purpose of this study is to evaluate the tolerability of azacitidine in addition to Interfant-06 standard chemotherapy in infants with newly diagnosed acute lymphoblastic leukemia (ALL) with KMT2A gene rearrangement (KMT2A-R).


You may be eligible for this study if you meet the following criteria:

  • Conditions: leukemia
  • Age: - 1 Years
  • Gender: Male or Female

Inclusion Criteria
Infants must be > 36 weeks gestational age at the time of enrollment
Patients must have newly diagnosed B lymphoblastic leukemia(also termed B-precursor acute lymphoblastic leukemia) or acute leukemia of ambiguous lineage (ALUL), which includes mixed phenotype acute leukemia (MPAL)
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 per protocol dosing, 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

Additional Information:
Participants will not be paid for their participation.

Updated on 22 Nov 2022 . Study ID: TX8311

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