Education and Training
Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A 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. 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.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Azacitidine
- drug: Cyclophosphamide
- drug: Cytarabine
- drug: Daunorubicin Hydrochloride
- drug: Dexamethasone
- drug: Hydrocortisone Sodium Succinate
- other: Laboratory Biomarker Analysis
- drug: Leucovorin Calcium
- drug: Mercaptopurine
- drug: Methotrexate
- drug: Pegaspargase
- other: Pharmacological Study
- drug: Prednisolone
- drug: Thioguanine
- drug: Vincristine Sulfate
- drug: Daunorubicin
- drug: Leucovorin
- drug: Vincristine
Eligibility
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
Ages Eligible for Study
N/A - 364 Days
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Nancy Sweeters
650-721-4074
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