Clinical Trials Search at Vanderbilt-Ingram Cancer Center
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
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
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
Treosulfan-Based Conditioning Regimen before a Blood or Bone Marrow Transplant for the Treatment of Bone Marrow Failure Diseases (BMT CTN 1904)
Multiple Cancer Types
This phase II trial tests whether treosulfan, fludarabine, and rabbit antithymocyte globulin (rATG) work when given before a blood or bone marrow transplant (conditioning regimen) to cause fewer complications for patients with bone marrow failure diseases. Chemotherapy drugs, such as treosulfan, 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. Fludarabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. rATG is used to decrease the body's immune response and may improve bone marrow function and increase blood cell counts. Adding treosulfan to a conditioning regimen with fludarabine and rATG may result in patients having less severe complications after a blood or bone marrow transplant.
Hematologic,
Pediatrics
II
Connelly, James
NCT04965597
VICCPED2192
A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
Multiple Cancer Types
The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab)
taken alone or together with standard chemotherapy for the potential treatment of colorectal
cancer that:
- has spread to other parts of the body (metastatic);
- has a certain type of abnormal gene called "BRAF"; and
- has not received prior treatment.
Participants in this study will receive one of the following study treatments:
- Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home
every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection
into the vein) at the study clinic.
- Encorafenib plus cetuximab with chemotherapy: These participants will receive
encorafenib and cetuximab in the way described in the bullet above. Additionally, they
will receive standard chemotherapy by IV infusion and oral treatment at home.
- Chemotherapy alone: These participants will receive chemotherapy, the standard treatment
for this condition, by IV infusion at the study clinics and oral treatment at home.
The study team will monitor how each participant responds to the study treatment for up to
about 3 years.
taken alone or together with standard chemotherapy for the potential treatment of colorectal
cancer that:
- has spread to other parts of the body (metastatic);
- has a certain type of abnormal gene called "BRAF"; and
- has not received prior treatment.
Participants in this study will receive one of the following study treatments:
- Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home
every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection
into the vein) at the study clinic.
- Encorafenib plus cetuximab with chemotherapy: These participants will receive
encorafenib and cetuximab in the way described in the bullet above. Additionally, they
will receive standard chemotherapy by IV infusion and oral treatment at home.
- Chemotherapy alone: These participants will receive chemotherapy, the standard treatment
for this condition, by IV infusion at the study clinics and oral treatment at home.
The study team will monitor how each participant responds to the study treatment for up to
about 3 years.
Colon,
Rectal
III
Eng, Cathy
NCT04607421
VICCGI2085
