Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia With Safety Run-in (Golden Gate Study)
The safety run-in part of the study aims to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy. The phase 3 part of the study aims to compare event-free survival (EFS) and overall survival (OS) of participants receiving blinatumomab alternating with low-intensity chemotherapy to EFS and (OS) of participants receiving standard of care (SOC) chemotherapy.
NCT04994717 — Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
Status: Recruiting
http://inclinicaltrials.com/other/NCT04994717/
A Multicentre, Roll-over Study to Provide Continued Treatment With Lyophilized Pegaspargase (S95014) in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL)
The purpose of this study is to provide treatment with lyophilized S95014 in pediatric patients with ALL who completed the CL2-95014-002 study during the induction phase and who are clinically benefitting from S95014 without major toxicity.
NCT04956666 — Acute Lymphoblastic Leukemia
Status: Completed
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT04956666/
A Multicentre, Phase II Randomized Study, Open-label, With 2-arm Parallel Group, Comparing the Pharmacokinetics of the Liquid and the Lyophilized Formulations of Pegaspargase (S95014) in Treatment of Paediatric Patients With Newly-Diagnosed Acute Lymphoblastic Leukemia (ALL)
The purpose of this study is to compare the pharmacokinetics (PK) of both lyophilized and liquid S95014 formulations during the induction phase after a single IV dose in newly diagnosed paediatric patients with ALL
NCT04954326 — Acute Lymphoblastic Leukemia
Status: Completed
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT04954326/
Clinical Study of ssCART-19 Cells in Patients With CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia
This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine the safety and efficacy of ssCART-19 in the treatment of patients with CD19 positive relapsed or refractory acute lymphoblastic leukemia.
NCT04825496 — Relapsed or Refractory Acute Lymphoblastic Leukemia
Status: Recruiting
http://inclinicaltrials.com/relapsed-or-refractory-acute-lymphoblastic-leukemia/NCT04825496/
Window Trial to Evaluate Molecular Response to PI3K Inhibition With Copanlisib in Relapsed or Refractory Adult B-cell Acute Lymphoblastic Leukemia
This study will provide an evaluation of biologic markers of leukemia cell response following a single dose of copanlisib prior to any salvage induction therapy in a projected cohort of 10 relapsed/refractory B-ALL patients.
NCT04803123 — Leukemia, Acute Lymphocytic
Status: Terminated
http://inclinicaltrials.com/leukemia-acute-lymphocytic/NCT04803123/
Senl-h19 CAR-T Cell Injection in the Treatment of Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
This study is an open, dose-escalating clinical study, taking patients with relapsed or refractory acute lymphoblastic leukemia as the test subjects, including mouse-derived CAR-T treatment failure or relapse, or for any reason cannot bridge the transplant r/r B-ALL.
NCT04792593 — B-ALL
Status: Recruiting
http://inclinicaltrials.com/b-all/NCT04792593/
Clinical Trial for the Safety and Efficacy of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Positive B-cell Acute Lymphoblastic Leukemia
Clinical Trial for the Safety and Efficacy of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Positive B-cell Acute Lymphoblastic Leukemia
NCT04788472 — B-Cell Acute Lymphoblastic Leukemia, Adult
Status: Recruiting
http://inclinicaltrials.com/b-cell-acute-lymphoblastic-leukemia-adult/NCT04788472/
Clinical Study of the Therapy Neurotoxicity Using Quantitative Assessment of the Brain Structures and Functions by MRI, EEG and Evoked Potentials in Patients With Acute Lymphoblastic Leukemia Over 6 Years Old
The study is aimed at assessing changes in the brain of patients from 6 to 18 years old with a diagnosis of acute lymphoblastic leukemia during chemotherapy.
NCT04767152 — Acute Leukemia
Status: Recruiting
http://inclinicaltrials.com/acute-leukemia/NCT04767152/
Alpha/Beta T-cell and B-cell Depleted Allogeneic Transplantation (IDE 13641) Followed by Blinatumomab Therapy for High-Risk B-Acute Lymphoblastic Leukemia: A Pilot Study
This trial will assess the feasibility of alpha/beta T-cell and B-cell depleted allogeneic hematopoietic cell transplantation (HCT) followed by blinatumomab therapy for high-risk B cell acute lymphoblastic leukemia (ALL) as a means of reducing rates of subsequent relapse and improving survival, while also minimizing treatment-related morbidity/ mortality and late effects. The conditioning regimens will be dependent on the patient's minimal residual disease (MRD) status prior to HCT using high throughput sequencing.
NCT04746209 — B-cell Acute Lymphoblastic Leukemia
Status: Recruiting
http://inclinicaltrials.com/b-cell-acute-lymphoblastic-leukemia/NCT04746209/
Clinical Trial for the Safety and Efficacy of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Negative B-cell Acute Lymphoblastic Leukemia
Clinical Trial for the Safety and Efficacy of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Negative B-cell Acute Lymphoblastic Leukemia
NCT04740203 — B-Cell Acute Lymphoblastic Leukemia, Adult
Status: Recruiting
http://inclinicaltrials.com/b-cell-acute-lymphoblastic-leukemia-adult/NCT04740203/