Clinical Trials Search at Vanderbilt-Ingram Cancer Center

This phase III trial compares hematopoietic (stem) cell transplantation (HCT) using mismatched related donors (haploidentical [haplo]) versus matched unrelated donors (MUD) in treating children, adolescents, and young adults with acute leukemia or myelodysplastic syndrome (MDS). HCT is considered standard of care treatment for patients with high-risk acute leukemia and MDS. In HCT, patients are given very high doses of chemotherapy or radiation therapy, which is intended to kill cancer cells that may be resistant to more standard doses of chemotherapy; unfortunately, this also destroys the normal cells in the bone marrow, including stem cells. After the treatment, patients must have a healthy supply of stem cells reintroduced or transplanted. The transplanted cells then reestablish the blood cell production process in the bone marrow. The healthy stem cells may come from the blood or bone marrow of a related or unrelated donor. If patients do not have a matched related donor, doctors do not know what the next best donor choice is or if a haplo related donor or MUD is better. This trial may help researchers understand whether a haplo related donor or a MUD HCT for children with acute leukemia or MDS is better or if there is no difference at all.

This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess
ziftomenib, a menin-MLL(KMT2A) inhibitor, in patients with relapsed or refractory acute
myeloid leukemia (AML) as part of Phase 1. In Phase 2, assessment of ziftomenib will continue
in patients with NPM1-m AML.

This is a prospective, multi-center, Phase II study of hematopoietic cell transplantation
(HCT) using human leukocyte antigen (HLA)-mismatched unrelated donors (MMUD) for peripheral
blood stem cell transplant in adults and bone marrow stem cell transplant in children.
Post-transplant cyclophosphamide (PTCy), tacrolimus and mycophenolate mofetil (MMF) will be
used for for graft versus host disease (GVHD) prophylaxis. This trial will study how well
this treatment works in patients with hematologic malignancies.

This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager (BiTE) that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.

This phase III trial compares the effect of adding levocarnitine to standard chemotherapy vs. standard chemotherapy alone in protecting the liver in patients with leukemia or lymphoma. Asparaginase is part of the standard of care chemotherapy for the treatment of acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LL), and mixed phenotype acute leukemia (MPAL). However, in adolescent and young adults (AYA) ages 15-39 years, liver toxicity from asparaginase is common and often prevents delivery of planned chemotherapy, thereby potentially compromising outcomes. Some groups of people may also be at higher risk for liver damage due to the presence of fat in the liver even before starting chemotherapy. Patients who are of Japanese descent, Native Hawaiian, Hispanic or Latinx may be at greater risk for liver damage from chemotherapy for this reason. Carnitine is a naturally occurring nutrient that is part of a typical diet and is also made by the body. Carnitine is necessary for metabolism and its deficiency or absence is associated with liver and other organ damage. Levocarnitine is a drug used to provide extra carnitine. Laboratory and real-world usage of the dietary supplement levocarnitine suggests its potential to prevent or reduce liver toxicity from asparaginase. The overall goal of this study is to determine whether adding levocarnitine to standard of care chemotherapy will reduce the chance of developing severe liver damage from asparaginase chemotherapy in ALL, LL and/or MPAL patients.

The goal of this clinical study is to learn more about the long-term safety, effectiveness
and prolonged action of Kite study drugs, axicabtagene ciloleucel, brexucabtagene autoleucel,
KITE-222, KITE-363, KITE-439, KITE-585, and KITE-718, in participants of Kite-sponsored
interventional studies.

This phase II trial tests how well decitabine and cedazuridine (DEC-C) works in combination with venetoclax in treating acute myeloid leukemia (AML) in patients whose AML has come back after a period of improvement (relapse) after a donor stem cell transplant. 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. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving DEC-C in combination with venetoclax may kill more cancer cells in patients with relapsed AML.

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.