Clinical Trials Search at Vanderbilt-Ingram Cancer Center
Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
Multiple Cancer Types
This is a global, multicenter Phase 1/3 study to evaluate the efficacy and safety of
selinexor plus ruxolitinib in JAK inhibitor (JAKi) treatment-nave myelofibrosis (MF)
participants. The study will be conducted in two phases: Phase 1 (open-label) and Phase 3
(double-blind). Phase 1 (enrollment completed) was an open-label evaluation of the safety and
recommended dose (RD) of selinexor in combination with ruxolitinib and included a dose
escalation using a standard 3+3 design (Phase 1a) and a dose expansion part (Phase 1b). In
Phase 3, JAKi treatment-nave MF participants are enrolled in 2:1 ratio to receive the
combination therapy of selinexor + ruxolitinib or the combination of placebo + ruxolitinib.
selinexor plus ruxolitinib in JAK inhibitor (JAKi) treatment-nave myelofibrosis (MF)
participants. The study will be conducted in two phases: Phase 1 (open-label) and Phase 3
(double-blind). Phase 1 (enrollment completed) was an open-label evaluation of the safety and
recommended dose (RD) of selinexor in combination with ruxolitinib and included a dose
escalation using a standard 3+3 design (Phase 1a) and a dose expansion part (Phase 1b). In
Phase 3, JAKi treatment-nave MF participants are enrolled in 2:1 ratio to receive the
combination therapy of selinexor + ruxolitinib or the combination of placebo + ruxolitinib.
Hematologic,
Phase I
I/II
Mohan, Sanjay
NCT04562389
VICCHEMP2130
Decitabine and Cedazuridine in Combination with Venetoclax for the Treatment of Patients who have Relapsed Acute Myeloid Leukemia after Donor Stem Cell Transplant
Leukemia
Leukemia
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.
Leukemia
II
Mohan, Sanjay
NCT05799079
VICCHEM2163
A Study to Compare Treatment with the Drug Selumetinib Alone versus Selumetinib and Vinblastine in Patients with Recurrent or Progressive Low-Grade Glioma
This phase III trial investigates the best dose of vinblastine in combination with selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib alone in treating children and young adults with low-grade glioma (a common type of brain cancer) that has come back after prior treatment (recurrent) or does not respond to therapy (progressive). Selumetinib is a drug that works by blocking a protein that lets tumor cells grow without stopping. Vinblastine blocks cell growth by stopping cell division and may kill cancer cells. Giving selumetinib in combination with vinblastine may work better than selumetinib alone in treating recurrent or progressive low-grade glioma.
Not Available
III
Esbenshade, Adam
NCT04576117
COGACNS1931
A Study to See if Memantine Protects the Brain during Radiation Therapy Treatment for Primary Central Nervous System Tumors
Multiple Cancer Types
This phase III trial compares memantine to usual treatment in treating patients with primary central nervous system tumors. Memantine may block receptors (parts of nerve cells) in the brain known to contribute to a decline in cognitive function. Giving memantine may make a difference in cognitive function (attention, memory, or other thought processes) in children and adolescents receiving brain radiation therapy to treat a primary central nervous system tumors.
Neuro-Oncology,
Pediatrics
III
Esbenshade, Adam
NCT04939597
COGACCL2031
Evaluation of Immunologic Response following COVID-19 Vaccination in Children, Adolescents, and Young Adults with Cancer
Pediatrics
Pediatrics
This study evaluates immunologic response following COVID-19 vaccination in children, adolescents, and young adults with cancer. Vaccines work by stimulating the bodys immune cells to respond against a specific disease. The immune response produces protection from that disease. Effects from cancer and from treatments for cancer can reduce the bodys natural disease fighting ability (called immunity). Factors such as vaccine type, timing of vaccine dosing related to treatment for cancer and number of vaccine doses or boosts (extra vaccine shots) may strengthen or diminish the bodys protective immune response. This study may help researchers learn more about how the bodys immune system responds to the COVID-19 vaccine when the vaccination is given during or after cancer treatment.
Pediatrics
N/A
Esbenshade, Adam
NCT05228275
COGACCL21C2
REACH (Research, Education, Advocacy, Clinical Care and Health) for Survivorship Program: Long Term Effects for Survivors of Cancer
Multiple Cancer Types
Miscellaneous,
Pediatrics
N/A
Esbenshade, Adam
VICCPED0710
Infectious Disease Outcomes in Pediatric Oncology Patients
Multiple Cancer Types
Miscellaneous,
Pediatrics
N/A
Esbenshade, Adam
VICCPED14127
Developing Evidence-Based Criteria for Initiating Treatment for Neurofibromatosis Type 1 Associated Optic Pathway Glioma
Multiple Cancer Types
Neuro-Oncology,
Pediatrics
N/A
Esbenshade, Adam
VICCPED17108
Expanded Access to Trametinib for a child with Plexiform Neurofibroma in NF1
Pediatrics
Pediatrics
Pediatrics
N/A
Esbenshade, Adam
VICCPED2251
Standard Chemotherapy in Treating Young Patients with Medulloblastoma or Other Central Nervous System Embryonal Tumors
Neuroblastoma (Pediatrics)
Neuroblastoma (Pediatrics)
This phase IV trial studies how well standard chemotherapy works in treating young patients with medulloblastoma or other central nervous system embryonal tumors. Drugs used in standard chemotherapy 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.
Neuroblastoma (Pediatrics)
IV
Esbenshade, Adam
NCT02875314
VICCPED1751
