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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



Evolutionary Inspired Therapy for the Treatment of Fusion Positive Newly Diagnosed, Metastatic Rhabdomyosarcoma

Multiple Cancer Types

This phase II trial investigates evolutionary inspired therapy in treating fusion positive rhabdomyosarcoma that is newly diagnosed and has spread to other places in the body (metastatic). Chemotherapy drugs, such as vinorelbine, vincristine sulfate, and actinomycin D, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cyclophosphamide is used to decrease the body's immune response and may inhibit DNA replication and initiate cell death. This study is being done to determine which of 4 different therapeutic treatments will have the best chance of the disease not worsening or coming back.
Pediatrics, Sarcoma
II
Borinstein, Scott
NCT04388839
VICCPED2134

LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis

Multiple Cancer Types

The LCH-IV is an international, multicenter, prospective clinical study for pediatric
Langerhans Cell Histiocytosis LCH (age < 18 years).
Miscellaneous, Pediatrics
III
Pastakia, Devang
NCT02205762
VICCPED2231

Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy

Breast

The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life
spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or
spread when compared to current available standard treatments, such as paclitaxel,
nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative
to the treatment of physician's choice (TPC) on progression-free survival (PFS).
Breast
III
Reid, Sonya
NCT05840211
VICC-DTBRE23078

Mismatched Related Donor versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults with Acute Leukemia or Myelodysplastic Syndrome

Multiple Cancer Types

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.
Leukemia, Myelodysplastic Syndrome, Pediatric Leukemia, Pediatric Lymphoma, Pediatrics
III
Kitko, Carrie
NCT05457556
COGASCT2031

A Randomized Study Investigating Preoperative Chemotherapy Followed by Surgery versus Surgery Alone in Patients with High Risk Retroperitoneal Sarcoma, STRASS2 Trial

Sarcoma

This phase III trial compares the effect of adding chemotherapy (doxorubicin or epirubicin hydrochloride [epirubicin] with ifosfamide or dacarbazine) before standard surgery versus surgery alone in improving long-term survival in patients with retroperitoneal sarcomas that are able to be removed by surgery (resectable). Chemotherapy drugs, such as doxorubicin, epirubicin, ifosfamide, and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before surgery may make the tumor smaller and easier to remove and may increase patient survival, compared to surgery alone.
Sarcoma
III
Davis, Elizabeth
NCT04031677
VICC-NTSAR23088

Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab or Rituximab and Chemotherapy

Hematologic

The purpose of this study is to determine the clinical benefit and characterize the safety
profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant
lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT)
after failure of rituximab and rituximab plus chemotherapy or (2) allogeneic hematopoietic
cell transplant (HCT) after failure of rituximab.
Hematologic
III
Dholaria, Bhagirathbhai
NCT03394365
VICCCTT1875

Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)

Multiple Cancer Types

A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone
(fludarabine/cytarabine/gemtuzumab ozogamicin [GO]) improves survival of
children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are
unable to receive additional anthracyclines, or in 2nd relapse.
Pediatric Leukemia, Pediatrics
III
Smith, Christine
NCT05183035
VICCPED2237

Selinexor and Venetoclax in Combination with Chemotherapy for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Leukemia of Ambiguous Lineage

Multiple Cancer Types

This phase I trial evaluates the side effects and best dose of selinexor and venetoclax in combination with chemotherapy in treating patients with acute myeloid leukemia or acute leukemia of ambiguous linage that has come back (relapsed) or does not respond to treatment. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Selinexor may stop the growth of cancer cells by blocking CRM1, which help the body's immune system to find and kill cancer cells. Chemotherapy drugs, such as fludarabine and cytarabine, 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. Colony-stimulating factors, such as granulocyte colony-stimulating factor, may increase the production of blood cells and may help the immune system recover from the side effects of chemotherapy. Giving venetoclax and selinexor with chemotherapy may help control the disease in patients with acute myeloid leukemia or acute leukemia of ambiguous lineage.
Leukemia, Pediatric Leukemia, Pediatrics, Phase I
I
Smith, Brianna
NCT04898894
VICCPEDP2235

First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia

Multiple Cancer Types

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.
Leukemia, Phase I
I/II
Savona, Michael
NCT04067336
VICCHEMP20122

CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)

Multiple Cancer Types

CB010A is a study evaluating safety, emerging efficacy, pharmacokinetics and immunogenicity
of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma after
lymphodepletion consisting of cyclophosphamide and fludarabine.
Lymphoma, Phase I
I
Oluwole, Olalekan
NCT04637763
VICC-DTCTT23155P

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trials, call 615-936-8422.