Clinical trials: P53 Mutation
Li Fraumeni Syndrome
LIFSCREEN : Evaluation of Whole Body MRI for Early Detection of Cancers in Subjects With P53 Mutation (Li-Fraumeni Syndrome)
The purpose of this study is to compare the diagnostic efficacy of two follow-up schedules for the early detection of cancers in the population under study on cancer incidence at 3 years.
- Trial name
- LIFSCREEN (NCT01464086)
- Testing
- whole body MRI
- Where
- France
- Volunteers
- 107 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
CNS Malignancies, Medulloblastoma Recurrent
A Phase 0/1 Study of cDNA for TP53, Checkpoint Inhibition and Radiation in Children With Recurrent, Progressive or Refractory CNS Malignancies.
This clinical trial is studying a drug called SGT-53 along with radiation and another drug called Nivolumab. It's for children with brain tumors that have come back, gotten worse, or didn't get better with earlier treatments.
- Conditions
- CNS Malignancies, Medulloblastoma Recurrent, ATRT Recurrent, Pineoblastoma
- Trial name
- JACOB (NCT07017816)
- Testing
- SGT-53, hypofractionated radiotherapy with immunotherapy, Nivolumab
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Children's National Research Institute
Li-Fraumeni Syndrome, Hereditary Cancer Syndromes
Biomarker Monitoring in TP53 Mutation Carriers
Purpose This study is an 'N-of-one' observational study focusing on individuals with a hereditary predisposition to cancer due to a genetic mutation in the TP53 gene.
- Conditions
- Li-Fraumeni Syndrome, Hereditary Cancer Syndromes, TP53 Gene Germline Mutation Carrier
- Trial name
- NCT02289326
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Scripps Health
Leukemia, Brain Tumor
Phase 1 Study of the Dual MDM2/MDMX Inhibitor ALRN-6924 in Pediatric Cancer
This research study is studying a novel drug called ALRN-6924 as a possible treatment for resistant (refractory) solid tumor, brain tumor, lymphoma or leukemia.
- Conditions
- Leukemia, Brain Tumor, Solid Tumor, Lymphoma
- Trial name
- NCT03654716
- Testing
- ALRN-6924, Cytarabine
- Where
- 4 sites in United States
- Volunteers
- 21 people
- Sponsor
- Dana-Farber Cancer Institute
Medulloblastoma Recurrent, Medulloblastoma, Childhood, Recurrent
Relapsed and Progressive Sonic Hedgehog Medulloblastoma With U1 Mutation Registry Study
The purpose of this study is to create a biobank for patients diagnosed with Sonic Hedgehog Medulloblastoma at Baylor College of Medicine/Texas Children's Cancer Center.
- Conditions
- Medulloblastoma Recurrent, Medulloblastoma, Childhood, Recurrent, Medulloblastoma, SHH-activated and TP53 Mutant, Medulloblastoma, SHH-activated and TP53 Wildtype
- Trial name
- NCT07242963
- Where
- 2 sites in United States
- Volunteers
- 300 people
- Sponsor
- Mohammad H. Abu Arja
Brain Tumors
International Society of Paediatric Oncology (SIOP) PNET 5 Medulloblastoma
The study PNET 5 MB has been designed for children with medulloblastoma of standard risk (according to the risk-group definitions which have been used so far; e.g. in PNET 4).
- Trial name
- NCT02066220
- Testing
- Radiotherapy without Carboplatin, Reduced-intensity maintenance chemotherapy, Radiotherapy with Carboplatin
- Where
- 77 sites in Austria, Belgium and 14 more
- Volunteers
- 360 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
TP53-mutated MDS and AML, Allogeneic Hematopoietic Stem Cell Transplantation
Maintenance Therapy With Selinexor and Azacitidine in TP53 Mutant AML/MDS After Transplantation
This study aims to explore the safety and efficacy of selinexor combined with azacitidine for maintenance therapy in TP53 mutant AML/MDS patients following transplantation.
- Trial name
- NCT07094464
- Testing
- Maintenance Therapy with Selinexor and Azacitidine
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Daihong Liu
Hematologic Malignancy, Acute Leukemia
MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies
This is a phase II, open-label, prospective study of T cell receptor alpha/beta depletion (TCR α/β TCD) peripheral blood stem cell (PBSC) transplantation for children and adults with hematological malignancies.
- Conditions
- Hematologic Malignancy, Acute Leukemia, Remission, Acute Myeloid Leukemia
- Trial name
- NCT05735717
- Testing
- Fludarabine, Busulfan, Melphalan
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Advanced Solid Tumor, Advanced Malignant Neoplasm
The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C…
- Conditions
- Advanced Solid Tumor, Advanced Malignant Neoplasm, Metastatic Cancer, Metastatic Solid Tumor
- Trial name
- NCT04585750
- Testing
- rezatapopt, pembrolizumab
- Where
- 76 sites in United States, Australia and 7 more
- Volunteers
- 300 people
- Sponsor
- PMV Pharmaceuticals, Inc
Acute Myeloid Leukemia, Stem Cell Transplantation
GRanulocyte Augmented Cord Blood Transplantation for Poor Risk leukaEmia
Allogeneic stem cell transplantation is the only potentially curative therapy for patients with high-risk Acute Myeloid Leukaemia, but relapse is common and remains the leading cause of death.
- Conditions
- Acute Myeloid Leukemia, Stem Cell Transplantation, Stem Cell Transplantation, Hematopoietic, Cord Blood Stem Cell Transplantation
- Trial name
- GRACE (NCT07372885)
- Testing
- Cord blood transplantation + conditioning + granulocytes of variable days according to study design
- Where
- 3 sites in United Kingdom
- Volunteers
- 50 people
- Sponsor
- University of Manchester
Pediatric Cancer, Li-Fraumeni Syndrome
Arsenic Trioxide Combined With Chemotherapy for the Treatment of p53-mutated Pediatric Cancer
This prospective, single-arm, multi-center clinical trial aims to explore and evaluate the efficacy and safety of arsenic trioxide combined with chemotherapy for pediatric cancer with p53 mutation.
- Conditions
- Pediatric Cancer, Li-Fraumeni Syndrome, p53 Mutations
- Trial name
- NCT06088030
- Testing
- Arsenic trioxide
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Yang Li
Acute Myeloid Leukemia, Myelodysplastic Syndromes
IFN-α in Relapse Prevention.
To investigate the efficacy of interferon-α prophylaxis in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) with TP53 mutation who were negative for minimal residual disease (MRD) by flow cytometry…
- Trial name
- NCT07449286
- Testing
- IFN-α
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Peking University People's Hospital
Medulloblastoma
Arsenic Trioxide Combined With Chemotherapy for Relapsed SHH-Activated and/or TP53-Mutant Medulloblastoma
This prospective, open-label, single-arm, multicenter study will evaluate the efficacy and safety of arsenic trioxide (ATO) combined with chemotherapy in pediatric patients with relapsed or refractory SHH-activated…
- Trial name
- NCT07856069
- Testing
- Arsenic Trioxide (ATO), ETOPOSIDE - Study, Cisplatin
- Where
- China
- Volunteers
- 78 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Hematopoietic Stem Cell Transplantation, TP53
Venetoclax and Decitabin Based Conditioning Regimen Followed With Post-HSCT Decitabin Maintenance Therapy in TP53 Mutant AML/MDS Patients
This study aims to evaluate the effectiveness and safety of Venetoclax and Decitabin based conditioning regimen followed with post-HSCT Decitabin maintenance therapy in TP53 mutant AML/MDS Patients.
- Trial name
- NCT05528354
- Testing
- VEN and DEC based conditioning regimen, DEC
- Where
- 4 sites in China
- Volunteers
- 58 people
- Sponsor
- Zhejiang University
Graves' Disease
Genetic Polymorphisms Associated With Cigarette Smoking and Risk of Graves' Disease
Cigarette smoking is a well-recognized risk factor of Graves' disease and, particularly, Graves' ophthalmopathy. Hence, germline polymorphisms of detoxification genes and genes belonging to the major DNA repair/apoptosis pathways…
- Trial name
- NCT00505011
- Volunteers
- 1,998 people, healthy volunteers welcome
- Sponsor
- University of Campinas, Brazil
Li-Fraumeni Syndrome, TP53 Gene Mutation
Li-Fraumeni & TP53 (LiFT UP): Understanding and Progress
The purpose of this research study is to learn more about variants in the TP53 gene both associated with Li-Fraumeni Syndrome (LFS), a hereditary cancer risk condition, and TP53 variants found in the blood for other reasons (e.g.
- Conditions
- Li-Fraumeni Syndrome, TP53 Gene Mutation, Hereditary Cancer Syndrome, Clonal Hematopoiesis
- Trial name
- LiFT_UP (NCT04541654)
- Testing
- Data and Specimen Collection
- Where
- 3 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Dana-Farber Cancer Institute
Myeloid Leukemia, Myelodysplastic Syndromes
Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT
To investigate the efficacy of interferon-α prophylaxis in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) with TP53 mutation who were negative for minimal residual disease (MRD) by flow cytometry…
- Trial name
- NCT06130579
- Testing
- IFN-Α
- Where
- China
- Volunteers
- 35 people
- Sponsor
- Peking University People's Hospital
Anaplastic Astrocytoma, Anaplastic Ependymoma
SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors
Approximately 90% of children with malignant brain tumors that have recurred or relapsed after receiving conventional therapy will die of disease.
- Conditions
- Anaplastic Astrocytoma, Anaplastic Ependymoma, Anaplastic Ganglioglioma, Anaplastic Meningioma
- Trial name
- NCT03434262
- Testing
- Gemcitabine, ribociclib, sonidegib
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- St. Jude Children's Research Hospital
Unresectable or Metastatic Melanoma or Advanced Solid Tumors, Melanoma
A Study of APG-115 in as a Monotherapy or Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors
This study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of APG-115, an MDM2 inhibitor, either alone or in combination with pembrolizumab, a programmed cell death protein-1 (PD-1) inhibitor…
- Conditions
- Unresectable or Metastatic Melanoma or Advanced Solid Tumors, Melanoma, Uveal Melanoma, P53 Mutation
- Trial name
- NCT03611868
- Testing
- Phase 1b: APG-115+pembrolizumab
- Where
- 21 sites in United States, Australia
- Volunteers
- 230 people
- Sponsor
- Ascentage Pharma Group Inc.
Li-Fraumeni Syndrome, Neoplasms
Clinical and Genetic Studies of Li-Fraumeni Syndrome
Background: Li-Fraumeni syndrome (LFS) is a genetic condition that increases the risk for some types of cancer. LFS may lead to cancer of the bone or connective tissue, breast, and brain.
- Conditions
- Li-Fraumeni Syndrome, Neoplasms, Tp53 Mutations
- Trial name
- NCT01443468
- Where
- 2 sites in United States
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- National Cancer Institute (NCI)