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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)

Multiple Cancer Types

The Phase 1 portion of this study is a single-arm, open-label, multicenter, non-randomized
interventional study to evaluate the pharmacokinetic (PK) interaction, safety, and efficacy
of ASTX727 when given in combination with venetoclax for the treatment of newly diagnosed
acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have
comorbidities that preclude use of intensive induction chemotherapy. The primary purpose of
the study is to rule out drug-drug interactions between ASTX727 and venetoclax combination
therapy by evaluating area under the curve (AUC) and maximum plasma concentration (Cmax)
exposure. The Phase 2 portion of the study is to assess the efficacy of ASTX727 and
venetoclax when given in combination and to evaluate potential PK interactions. Phase 2 will
follow the same overall study design as Phase 1 and has two parts, Part A and Part B.
Leukemia, Phase I
I/II
Savona, Michael
NCT04657081
VICCHEMP20102

Active Myeloid Target Compound Decitabine and Cedazuridine in Combination with Itacitinib for the Treatment of Myelodysplastic/Myeloproliferative Neoplasm (MDS/MPN) Overlap Syndromes, ABNL-MARRO Study

Multiple Cancer Types

This phase I/II trial tests the safety, side effects, and best dose of decitabine and cedazuridine (ASTX727) in combination with itacitinib and how well they work in treating patients with myelodysplastic/ myeloproliferative neoplasm. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Itacitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving decitabine and cedazuridine in combination with itacitinib may work better in treating patients with myelodysplastic/myeloproliferative neoplasm.
Hematologic, Myelodysplastic Syndrome
I/II
Savona, Michael
NCT04061421
VICCHEMP1977

A Trial Comparing Unrelated Donor BMT With IST for Pediatric and Young Adult Patients With Severe Aplastic Anemia (TransIT, BMT CTN 2202)

Pediatrics

Severe Aplastic Anemia (SAA) is a rare condition in which the body stops producing enough new
blood cells. SAA can be cured with immune suppressive therapy or a bone marrow transplant.
Regular treatment for patients with aplastic anemia who have a matched sibling (brother or
sister), or family donor is a bone marrow transplant. Patients without a matched family donor
normally are treated with immune suppressive therapy (IST). Match unrelated donor (URD) bone
marrow transplant (BMT) is used as a secondary treatment in patients who did not get better
with IST, had their disease come back, or a new worse disease replaced it (like leukemia).

This trial will compare time from randomization to failure of treatment or death from any
cause of IST versus URD BMT when used as initial therapy to treat SAA.

The trial will also assess whether health-related quality of life and early markers of
fertility differ between those randomized to URD BMT or IST, as well as assess the presence
of marrow failure-related genes and presence of gene mutations associated with MDS or
leukemia and the change in gene signatures after treatment in both study arms.

This study treatment does not include any investigational drugs. The medicines and procedures
in this study are standard for treatment of SAA.
Pediatrics
III
Connelly, James
NCT05600426
VICCPED2295

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