Clinical Trials Search at Vanderbilt-Ingram Cancer Center
Nivolumab in Combination with Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma
Multiple Cancer Types
This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs 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. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.
Lymphoma,
Pediatric Lymphoma,
Pediatrics
III
Smith, Christine
NCT04759586
COGANHL1931
Haploidentical Bone Marrow Transplantation in Sickle Cell Patients (BMTCTN1507)
Hematologic
Hematologic
This is a Phase II, single arm, multi-center trial, designed to estimate the efficacy and
toxicity of haploidentical bone marrow transplantation (BMT) in patients with sickle cell
disease (SCD). Based on their age and entry criteria patients are stratified into two groups:
(1) children with severe SCD; and (2) adults with severe SCD.
toxicity of haploidentical bone marrow transplantation (BMT) in patients with sickle cell
disease (SCD). Based on their age and entry criteria patients are stratified into two groups:
(1) children with severe SCD; and (2) adults with severe SCD.
Hematologic
II
Kassim, Adetola
NCT03263559
VICCNCCTT1759
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
Hematologic
Hematologic
This study is an access and distribution protocol for unlicensed cryopreserved cord blood
units (CBUs) in pediatric and adult patients with hematologic malignancies and other
indications.
units (CBUs) in pediatric and adult patients with hematologic malignancies and other
indications.
Hematologic
N/A
Kassim, Adetola
NCT01351545
VICCCTT1158
CIBMTR Research Database
Hematologic
Hematologic
The primary purpose of the Research Database is to have a comprehensive source of
observational data that can be used to study HSC transplantation and cellular therapies.
A secondary purpose of the Research Database is to have a comprehensive source of data to
study marrow toxic injuries.
Objectives:
To learn more about what makes stem cell transplants and cellular therapies work well such
as:
- Determine how well recipients recover from their transplants or cellular therapy;
- Determine how recovery after a transplant or cellular therapy can be improved;
- Determine how a donor's or recipient's genetics impact recipient recovery after a
transplant or cellular therapy;
- Determine how access to transplant or cellular therapy for different groups of patients
can be improved;
- Determine how well donors recover from the collection procedures.
observational data that can be used to study HSC transplantation and cellular therapies.
A secondary purpose of the Research Database is to have a comprehensive source of data to
study marrow toxic injuries.
Objectives:
To learn more about what makes stem cell transplants and cellular therapies work well such
as:
- Determine how well recipients recover from their transplants or cellular therapy;
- Determine how recovery after a transplant or cellular therapy can be improved;
- Determine how a donor's or recipient's genetics impact recipient recovery after a
transplant or cellular therapy;
- Determine how access to transplant or cellular therapy for different groups of patients
can be improved;
- Determine how well donors recover from the collection procedures.
Hematologic
N/A
Kassim, Adetola
NCT01166009
VICCCTT1110
Studying the Effect of Levocarnitine in Protecting the Liver from Chemotherapy for Leukemia or Lymphoma
Multiple Cancer Types
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.
Leukemia,
Pediatric Leukemia
III
Borinstein, Scott
NCT05602194
VICC-NTPED23475
Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study
This study will validate a previously developed pediatric prognostic biomarker algorithm
aimed at improving prediction of risk for the later development of chronic graft-versus-host
disease (cGvHD) in children and young adults undergoing allogeneic hematopoietic stem cell
transplant.
By developing an early risk stratification of patients into low-, intermediate-, and
high-risk for future cGvHD development (based upon their biomarker profile, before the onset
of cGvHD), pre-emptive therapies aimed at preventing the onset of cGvHD can be developed
based upon an individual's biological risk profile.
This study will also continue research into diagnostic biomarkers of cGvHD, and begin work
into biomarker models that predict clinical response to cGvHD therapies.
aimed at improving prediction of risk for the later development of chronic graft-versus-host
disease (cGvHD) in children and young adults undergoing allogeneic hematopoietic stem cell
transplant.
By developing an early risk stratification of patients into low-, intermediate-, and
high-risk for future cGvHD development (based upon their biomarker profile, before the onset
of cGvHD), pre-emptive therapies aimed at preventing the onset of cGvHD can be developed
based upon an individual's biological risk profile.
This study will also continue research into diagnostic biomarkers of cGvHD, and begin work
into biomarker models that predict clinical response to cGvHD therapies.
Not Available
N/A
Kitko, Carrie
NCT04372524
VICCPED2183
Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in Patients With TRK Fusion Cancer Which is Locally Advanced or Spread From the Place Where it Started to Other Places in the Body
Multiple Cancer Types
In this observational study researcher want to learn more about the effectiveness of drug
VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use
in patients with TRK fusion cancer which is locally advanced or spread from the place where
it started to other places in the body. TRK fusion cancer is a term used to describe a
variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic
Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or
fuses, with a different gene. This joining results in the activation of certain proteins (TRK
fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an
approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult
and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the
decision to treat their disease with VITRAKVI has been made by their treating physicians.
During the study, patients' medical information such as treatment information with VITRAKVI,
other medication or treatments, changes in disease status and other health signs and symptoms
will be collected within the normal medical care by the treating doctor. Participants will be
observed over a period from 24 to 60 months.
VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use
in patients with TRK fusion cancer which is locally advanced or spread from the place where
it started to other places in the body. TRK fusion cancer is a term used to describe a
variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic
Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or
fuses, with a different gene. This joining results in the activation of certain proteins (TRK
fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an
approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult
and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the
decision to treat their disease with VITRAKVI has been made by their treating physicians.
During the study, patients' medical information such as treatment information with VITRAKVI,
other medication or treatments, changes in disease status and other health signs and symptoms
will be collected within the normal medical care by the treating doctor. Participants will be
observed over a period from 24 to 60 months.
Pediatric Solid Tumors,
Pediatrics
N/A
Borinstein, Scott
NCT04142437
VICCPED2071
A Trial Comparing Unrelated Donor BMT With IST for Pediatric and Young Adult Patients With Severe Aplastic Anemia (TransIT, BMT CTN 2202)
Pediatrics
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.
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
Vorinostat in Preventing Graft Versus Host Disease in Children, Adolescents, and Young Adults Undergoing Blood and Bone Marrow Transplant
Multiple Cancer Types
This phase I/II trial studies the side effects and best dose of vorinostat in preventing graft versus host disease in children, adolescents, and young adults who are undergoing unrelated donor blood and bone marrow transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells, called graft-versus-host disease. During this process, chemicals (called cytokines) are released that may damage certain body tissues, including the gut, liver and skin. Vorinostat may be an effective treatment for graft-versus-host disease caused by a bone marrow transplant.
Hematologic,
Pediatric Leukemia,
Pediatric Lymphoma
I/II
Kitko, Carrie
NCT03842696
VICCPED2133
Open-Label, Long-Term Safety and Efficacy Study of Mim8 in Participants with Haemophilia A with or without Inhibitors
Not Available
III
Wheeler, Allison
NCT05685238
NCBH2401-FRONTIER4
