Acute Lymphoblastic Leukemia, in Relapse Clinical Trial
Official title:
International Proof of Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory HEMatological Malignancies in Children, Subprotocol A: Decitabine / Venetoclax and Navitoclax in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
HEM-iSMART is a master protocol which investigates multiple investigational medicinal products in children, adolescents and young adults (AYA) with relapsed/refractory (R/R) ALL and LBL. Sub-protocol A is a phase I/II trial evaluating the safety and efficacy of Decitabine / Venetoclax and Navitoclax in children and AYA with R/R pediatric ALL/LBL
HEM-iSMART is a master protocol with sub-protocols. The overarching objective is that introducing targeted therapy using a biomarker driven approach for treatment stratification may improve the outcome of children with R/R acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) It is characterized by a shared framework that allows for the investigation of multiple IMPs and generate pivotal safety and efficacy evidence within the sub-protocols to establish and define the benefits and risks of new treatments for children with R/R leukemia. Sub-protocol A within HEM-iSMART, is a phase I/II, multicenter, international, open-label clinical trial designed to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of decitabine, venetoclax and navitoclax in children, adolescents and young with R/R ALL and LBL. The epigenetic approach may improve outcome for patients whose tumor lack molecular alterations. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05066958 -
Ex-vivo Primed Memory Donor Lymphocyte Infusion to Boost Anti-viral Immunity After T-cell Depleted HSCT
|
Phase 1/Phase 2 | |
| Completed |
NCT04224571 -
CCCG Relapsed Acute Lymphoblastic Leukemia 2017 Study in Children
|
Phase 2 | |
| Recruiting |
NCT04888442 -
Phase I Study of pCAR-19B in the Treatment of Adult CD19-positive Relapsed/Refractory B-ALL
|
Phase 1 | |
| Recruiting |
NCT05809284 -
Determining the Mechanisms of Loss of CAR T Cell Persistence
|
||
| Recruiting |
NCT04049383 -
CAR-20/19-T Cells in Patients With Relapsed/Refractory B Cell ALL
|
Phase 1 | |
| Not yet recruiting |
NCT05745714 -
HEM-iSMART-C: Ruxolitinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT06213636 -
Fourth-gen CAR T Cells Targeting CD19/CD22 for Highly Resistant B-cell Lymphoma/Leukemia (PMBCL/CNS-BCL).
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04603872 -
CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Hematological Malignancies
|
Early Phase 1 | |
| Recruiting |
NCT04475731 -
Ponatinib in Adult Ph+ ALL Patients With MRD Positivity or Hematological Relapse
|
Phase 2 | |
| Recruiting |
NCT06445803 -
CD19/CD22 CAR-T Cells in Adults With R/R ALL or NHL
|
Phase 1 | |
| Recruiting |
NCT03957915 -
Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia
|
Early Phase 1 | |
| Terminated |
NCT03705507 -
International Trial of Selumetinib in Combination With Dexamethasone for the Treatment of Acute Lymphoblastic Leukaemia
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04605666 -
CD19-CAR-T2 Cells for CD19 Positive Acute Lymphoblastic Leukemia
|
Phase 2 | |
| Recruiting |
NCT04340167 -
Study of Anti-CD22 CAR-T Cells Treating Leukemia Children
|
Phase 2 | |
| Recruiting |
NCT04325841 -
Phase II Study of Anti-CD19 CAR-T Cells Treating Leukemia Children
|
Phase 2 | |
| Active, not recruiting |
NCT04340154 -
Study of Sequential CAR-T Cell Treating Leukemia Children
|
Phase 2 | |
| Recruiting |
NCT05292664 -
Venetoclax Basket Trial for High Risk Hematologic Malignancies
|
Phase 1 | |
| Recruiting |
NCT06316427 -
Autologous and Donor-derived CD7 CAR-T Therapy in Refractory or Relapsed T-cell Acute Lymphoblastic Leukemia/Lymphoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05310591 -
Combination of an Anti-PD1 Antibody With Tisagenlecleucel Reinfusion in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia After Loss of Persistence
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT05705570 -
A Phase I Clinical Trial Using Genetically Engineered Autologous T Cells to Express Chimeric Antigen Receptor (CAR) for Treatment of Patients With Refractory or Relapsed CD19-positive B Lymphoid Malignancies
|
Phase 1 |