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| Consuelo Wilkins, MD, MSCI, Senior Vice President for Health Equity and Inclusive Excellence for Vanderbilt University Medical Center (VUMC) and Senior Associate Dean for Health Equity and Inclusive Excellence for Vanderbilt University School of Medicine, always knew she wanted to be a physician. "Health equity was built into everything I did, even if I didn’t know it or recognize it at the time," Wilkins said. "I have always learned and believed that people are the same — everyone deserves to be healthy, and everyone should have the best opportunities to take care of themselves and their families." Click below to learn more about health equity initiatives. https://momentum.vicc.org/2021/09/everyone-deserves-to-be-healthy/ |
Vanderbilt was the lead site for an NIH-funded, phase 2, multicenter influenza vaccine study in pediatric allogeneic hematopoietic stem cell transplant (HCT) recipients that may lead to a change in the current flu vaccine recommendations in this vulnerable population. Natasha Halasa, MD, MPH and colleagues recently published in the New England Journal of Medicine, that two doses of high-dose trivalent flu vaccine resulted in higher amounts of influenza-specific antibodies than two doses of standard dose quadrivalent vaccine. https://news.vumc.org/2023/03/02/high-dose-flu-vaccine-beneficial-for-pediatric-stem-cell-transplant-patients/ |
Conditioning SCID Infants Diagnosed Early
Multiple Cancer Types
The investigators want to study if lower doses of chemotherapy will help babies with SCID to
achieve good immunity with less short and long-term risks of complications after
transplantation. This trial identifies babies with types of immune deficiencies that are most
likely to succeed with this approach and offers them transplant early in life before they get
severe infections or later if their infections are under control. It includes only patients
receiving unrelated or mismatched related donor transplants.
The study will test if patients receiving transplant using either a low dose busulfan or a
medium dose busulfan will have immune recovery of both T and B cells, measured by the ability
to respond to immunizations after transplant. The exact regimen depends on the subtype of
SCID the patient has. Donors used for transplant must be unrelated or half-matched related
(haploidentical) donors, and peripheral blood stem cells must be used. To minimize the chance
of graft-versus-host disease (GVHD), the stem cells will have most, but not all, of the T
cells removed, using a newer, experimental approach of a well-established technology. Once
the stem cell transplant is completed, patients will be followed for 3 years. Approximately
9-18 months after the transplant, vaccinations will be administered, and a blood test
measuring whether your child's body has responded to the vaccine will be collected.
achieve good immunity with less short and long-term risks of complications after
transplantation. This trial identifies babies with types of immune deficiencies that are most
likely to succeed with this approach and offers them transplant early in life before they get
severe infections or later if their infections are under control. It includes only patients
receiving unrelated or mismatched related donor transplants.
The study will test if patients receiving transplant using either a low dose busulfan or a
medium dose busulfan will have immune recovery of both T and B cells, measured by the ability
to respond to immunizations after transplant. The exact regimen depends on the subtype of
SCID the patient has. Donors used for transplant must be unrelated or half-matched related
(haploidentical) donors, and peripheral blood stem cells must be used. To minimize the chance
of graft-versus-host disease (GVHD), the stem cells will have most, but not all, of the T
cells removed, using a newer, experimental approach of a well-established technology. Once
the stem cell transplant is completed, patients will be followed for 3 years. Approximately
9-18 months after the transplant, vaccinations will be administered, and a blood test
measuring whether your child's body has responded to the vaccine will be collected.
Hematologic,
Pediatrics
II
Connelly, James
NCT03619551
VICCNCPED18122
Carboplatin with or without Pembrolizumab in Treating Patients with Advanced Breast Cancer with Locally Recurrent Chest Wall Disease That Cannot Be Removed by Surgery
Breast
Breast
This phase II trial studies the effect of carboplatin with or without pembrolizumab in treating patients with breast cancer that has spread to other places in the body (advanced) with chest wall disease that has come back (locally recurrent) and cannot be removed by surgery. Drugs used in chemotherapy, such as carboplatin, 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. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Breast
II
Abramson, Vandana
NCT03095352
VICCBRE1808
Study of BMF-219, a Covalent Menin Inhibitor, in Adult Patients With AML, ALL (With KMT2A/ MLL1r, NPM1 Mutations), DLBCL, MM, and CLL/SLL
Multiple Cancer Types
A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-219, an oral
covalent menin inhibitor, in adult patients with AML, ALL (with KMT2A/ MLL1r, NPM1
mutations), DLBCL, MM, and CLL/SLL.
covalent menin inhibitor, in adult patients with AML, ALL (with KMT2A/ MLL1r, NPM1
mutations), DLBCL, MM, and CLL/SLL.
Leukemia,
Phase I
I
Kishtagari, Ashwin
NCT05153330
VICCHEMP2195
Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B)
Substudy 03B is part of a larger research study that is testing experimental treatments for
renal cell carcinoma (RCC). The larger study is the umbrella study (U03).
The goal of substudy 03B is to evaluate the safety and efficacy of experimental combinations
of investigational agents in participants with advanced second line plus (2L+) clear cell
renal cell carcinoma (ccRCC).
This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety
lead-in phase will be used to demonstrate a tolerable safety profile for the combination of
investigational agents. There will be no hypothesis testing in this study.
renal cell carcinoma (RCC). The larger study is the umbrella study (U03).
The goal of substudy 03B is to evaluate the safety and efficacy of experimental combinations
of investigational agents in participants with advanced second line plus (2L+) clear cell
renal cell carcinoma (ccRCC).
This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety
lead-in phase will be used to demonstrate a tolerable safety profile for the combination of
investigational agents. There will be no hypothesis testing in this study.
Not Available
I/II
Beckermann, Kathryn
NCT04626518
VICCUROP2070
Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNOTE-867)
Multiple Cancer Types
The purpose of this study is to assess the efficacy and safety of stereotactic body
radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with
unresected stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC).
The primary study hypotheses are:
1. SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo
(normal saline solution), and
2. SBRT plus pembrolizumab prolongs Overall Survival (OS) compared to SBRT plus placebo.
radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with
unresected stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC).
The primary study hypotheses are:
1. SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo
(normal saline solution), and
2. SBRT plus pembrolizumab prolongs Overall Survival (OS) compared to SBRT plus placebo.
Lung,
Non Small Cell
III
Osmundson, Evan
NCT03924869
VICCTHO1940
KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment
Multiple Cancer Types
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the
treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with a JAK
inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF.
This study will be conducted in 2 phases. Phase 2 will determine the KRT-232 recommended dose
and dosing schedule; Phase 3 will test KRT-232 vs Best Available Therapy (BAT). Patients in
the Phase 3 part of the study will be randomized 2:1 to receive either KRT-232 (Arm 1) or BAT
(Arm 2). The BAT administered will be determined by the treating physician, with the option
to "cross-over" to KRT-232 treatment after 6 months of BAT or if the disease worsens at any
time.
treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with a JAK
inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF.
This study will be conducted in 2 phases. Phase 2 will determine the KRT-232 recommended dose
and dosing schedule; Phase 3 will test KRT-232 vs Best Available Therapy (BAT). Patients in
the Phase 3 part of the study will be randomized 2:1 to receive either KRT-232 (Arm 1) or BAT
(Arm 2). The BAT administered will be determined by the treating physician, with the option
to "cross-over" to KRT-232 treatment after 6 months of BAT or if the disease worsens at any
time.
Hematologic,
Leukemia
II
Savona, Michael
NCT03662126
VICCHEM18136
Study of Axicabtagene Ciloleucel Given With Steroids In Participants With Relapsed Or Refractory Large B-Cell Lymphoma
Lymphoma
Lymphoma
The goal of this clinical study is to learn more about the study drug, axicabtagene
ciloleucel, in participants with relapsed or refractory large B-cell lymphoma (LBCL) in the
outpatient setting.
ciloleucel, in participants with relapsed or refractory large B-cell lymphoma (LBCL) in the
outpatient setting.
Lymphoma
II
Oluwole, Olalekan
NCT05459571
VICCCTT2233
A Study of ASTX030 (Cedazuridine in Combination With Azacitidine) in MDS, CMML, or AML
Multiple Cancer Types
Study ASTX030-01 is designed to move efficiently from Phase 1 to Phase 3. Phase 1 consists of
an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose
levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time)
followed by a Dose Expansion Stage (Stage B) of ASTX030. Phase 2 is a randomized open-label
crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 is a
randomized open-label crossover study comparing the final oral ASTX030 dose to SC
azacitidine. The duration of the study is expected to be approximately 48 months.
an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose
levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time)
followed by a Dose Expansion Stage (Stage B) of ASTX030. Phase 2 is a randomized open-label
crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 is a
randomized open-label crossover study comparing the final oral ASTX030 dose to SC
azacitidine. The duration of the study is expected to be approximately 48 months.
Leukemia,
Myelodysplastic Syndrome,
Phase I
I/II/III
Savona, Michael
NCT04256317
VICCHEMP19146
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
Hypofractionated Radiotherapy Followed by Immediate Surgery for the Treatment of Soft Tissue Sarcomas
Sarcoma
Sarcoma
This phase II trial studies the effect of hypofractionated radiotherapy followed by immediate surgery in treating patients with soft tissue sarcoma. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving hypofractionated radiotherapy followed by immediate surgery may allow patients with sarcomas to be treated in a much more rapid and convenient fashion.
Sarcoma
II
Shinohara, Eric
NCT04506008
VICCSAR2062
