The First Affiliated Hospital of Soochow University — Biomedical Watch V2

Traitements5programmes

Essais1liés

Publications11liées

SourceDBlocale

Traitements

5

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Antithymocyte Globulin (ATG)This study evaluates the effectiveness and safety of a new conditioning regimen called VABu before stem cell transplantation in patients with acute myeloid leukemia (AML) who are in their first complete remission (CR1), classified as non-high-risk per ELN 2022 guidelines, but have poor physical condition (ECOG performance status ≥ 2) or high comorbidity burden (HCT-CI ≥ 2). VABu combines venetoclax, azacitidine (or decitabine as an alternative), and busulfan. This is a single-arm, prospective study with 42 participants. All participants will receive the VABu regimen followed by stem cell transplantation. The primary outcome measure is 2-year overall survival (OS). Secondary outcomes include 2-year relapse-free survival (RFS), transplant-related mortality (TRM), engraftment failure rate, bloodstream infection (BSI), and 2-year all-cause mortality and non-relapse mortality (NRM). The study is conducted at the First Affiliated Hospital of Soochow University.	Cancer	Non applicable	Thérapie cellulaire	China	À vérifier
Azacitidine (AZA)This study evaluates the effectiveness and safety of a new conditioning regimen called VABu before stem cell transplantation in patients with acute myeloid leukemia (AML) who are in their first complete remission (CR1), classified as non-high-risk per ELN 2022 guidelines, but have poor physical condition (ECOG performance status ≥ 2) or high comorbidity burden (HCT-CI ≥ 2). VABu combines venetoclax, azacitidine (or decitabine as an alternative), and busulfan. This is a single-arm, prospective study with 42 participants. All participants will receive the VABu regimen followed by stem cell transplantation. The primary outcome measure is 2-year overall survival (OS). Secondary outcomes include 2-year relapse-free survival (RFS), transplant-related mortality (TRM), engraftment failure rate, bloodstream infection (BSI), and 2-year all-cause mortality and non-relapse mortality (NRM). The study is conducted at the First Affiliated Hospital of Soochow University.	Cancer	Non applicable	Thérapie cellulaire	China	À vérifier
Busulfan (BU)This study evaluates the effectiveness and safety of a new conditioning regimen called VABu before stem cell transplantation in patients with acute myeloid leukemia (AML) who are in their first complete remission (CR1), classified as non-high-risk per ELN 2022 guidelines, but have poor physical condition (ECOG performance status ≥ 2) or high comorbidity burden (HCT-CI ≥ 2). VABu combines venetoclax, azacitidine (or decitabine as an alternative), and busulfan. This is a single-arm, prospective study with 42 participants. All participants will receive the VABu regimen followed by stem cell transplantation. The primary outcome measure is 2-year overall survival (OS). Secondary outcomes include 2-year relapse-free survival (RFS), transplant-related mortality (TRM), engraftment failure rate, bloodstream infection (BSI), and 2-year all-cause mortality and non-relapse mortality (NRM). The study is conducted at the First Affiliated Hospital of Soochow University.	Cancer	Non applicable	Thérapie cellulaire	China	À vérifier
Cytarabine (Ara-C)This study evaluates the effectiveness and safety of a new conditioning regimen called VABu before stem cell transplantation in patients with acute myeloid leukemia (AML) who are in their first complete remission (CR1), classified as non-high-risk per ELN 2022 guidelines, but have poor physical condition (ECOG performance status ≥ 2) or high comorbidity burden (HCT-CI ≥ 2). VABu combines venetoclax, azacitidine (or decitabine as an alternative), and busulfan. This is a single-arm, prospective study with 42 participants. All participants will receive the VABu regimen followed by stem cell transplantation. The primary outcome measure is 2-year overall survival (OS). Secondary outcomes include 2-year relapse-free survival (RFS), transplant-related mortality (TRM), engraftment failure rate, bloodstream infection (BSI), and 2-year all-cause mortality and non-relapse mortality (NRM). The study is conducted at the First Affiliated Hospital of Soochow University.	Cancer	Non applicable	Thérapie cellulaire	China	À vérifier
Decitabine 20 mg/m²/day for 5 daysThis study evaluates the effectiveness and safety of a new conditioning regimen called VABu before stem cell transplantation in patients with acute myeloid leukemia (AML) who are in their first complete remission (CR1), classified as non-high-risk per ELN 2022 guidelines, but have poor physical condition (ECOG performance status ≥ 2) or high comorbidity burden (HCT-CI ≥ 2). VABu combines venetoclax, azacitidine (or decitabine as an alternative), and busulfan. This is a single-arm, prospective study with 42 participants. All participants will receive the VABu regimen followed by stem cell transplantation. The primary outcome measure is 2-year overall survival (OS). Secondary outcomes include 2-year relapse-free survival (RFS), transplant-related mortality (TRM), engraftment failure rate, bloodstream infection (BSI), and 2-year all-cause mortality and non-relapse mortality (NRM). The study is conducted at the First Affiliated Hospital of Soochow University.	Cancer	Non applicable	Thérapie cellulaire	China	À vérifier

Essais cliniques

1

Molécule	Indication / population	Phase	NCT	Titre	Statut
Venetoclax	Cancer	Non applicable	NCT07762508	A Prospective Single-Arm Study of VABu Conditioning Regimen in Allo-HSCT for Low-Performance or High-Comorbidity AML Patients in CR1	NOT_YET_RECRUITING

Publications

11

Molécule	Indication / population	Titre	Journal	Date
Antithymocyte Globulin (ATG)		Reinterpreting the matched-sibling relapse penalty in ATG-based allogeneic transplantation for myelodysplastic neoplasms: a question of dose, not donor.	Annals of hematology
Antithymocyte Globulin (ATG)		Reduced-Dose PTCy Plus Post-Engraftment Low-Dose ATG for GVHD Prophylaxis in Haploidentical PBSC Transplantation.	Transplantation and cellular therapy
Antithymocyte Globulin (ATG)		Are HLA-Haploidentical Relatives a Donor Choice for Patients With Severe Aplastic Anemia? A GATMO-TC Experience.	Transplantation and cellular therapy
Busulfan (BU)		Restoration of spermatogenesis is dependent on activation of a SPRY4-ERK checkpoint following germline stem cell damage†.	Biology of reproduction
Busulfan (BU)		Impact of conditioning regimen on outcomes of young AML patients ( < 40 years) undergoing HCT in complete remission, with transplant conditioning intensity score of 3.5-4.0. A study from the acute leukemia working party of the European Society for Blood and Marrow Transplantation.	Bone marrow transplantation
Busulfan (BU)		Association of Busulfan Exposure with Event-Free Survival in a Chinese Pediatric Cohort: A Multicenter, Prospective Cohort Study.	Drug design, development and therapy
Cytarabine (Ara-C)		Nitazoxanide cooperates with cytarabine to inhibit cytarabine-resistant acute myeloid leukemia progression via mitochondrial dysfunction and PLK1 suppression.	Biochemical pharmacology
Decitabine 20 mg/m²/day for 5 days		Very-low-dose decitabine and rhTPO for thrombocytopenia in lower-risk myelodysplastic syndrome.	Annals of hematology
Decitabine 20 mg/m²/day for 5 days		Decitabine plus all- retinoic acid decitabine monotherapy for myelodysplastic syndromes with excess blasts: a multicenter, randomized controlled trial.	Haematologica
Decitabine 20 mg/m²/day for 5 days		Dual BCL-xL and BCL-2 Inhibition for Advanced Myeloid Neoplasms: A Phase I Dose-Escalation Study of Navitoclax, Venetoclax, and Decitabine.	Clinical cancer research : an official journal of the American Association for Cancer Research
Azacitidine (AZA)		DNA methyltransferase inhibitors in oncology: clinical progress, limitations and future directions.	Epigenomics