An Open, Uncontrolled, Multicenter Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of Chimeric Antigen Receptor T Cell (CAR-T) in the Treatment of Children With Relapsed and Refractory Acute Lymphoblastic Leukemia
In this study, CAR-T will be administered to children with acute lymphoblastic leukemia to explore the effect of CAR-T intervention time on the duration of complete remission and further verify the long-term safety and efficacy of CAR-T treatment.
NCT04626765 — Childhood Acute Lymphoblastic Leukemia
Status: Recruiting
http://inclinicaltrials.com/childhood-acute-lymphoblastic-leukemia/NCT04626765/
CD19-Chimeric Antigen Receptor-T2 Cells for CD19 Positive Acute Lymphoblastic Leukemia
Relapsed and refractory B cell acute lymphoblastic leukemia (B-ALL) shows unfavorable prognosis, especially for adult patients. Besides, minimal residual disease (MRD) positive at transplant has been considered risk factor for relapse after transplantation. Worse yet, there is no standard management for these patients. Chimeric antigen receptor T cells (CAR-T cells) has been recognized a promising treatment option for treating B cell derived malignancy. The purpose of this study is to evaluate the efficacy and safety of chimeric antigen receptor 19 (CD19-CAR-T2 Cells) infusions in patients with CD19+ ALL.
NCT04605666 — Acute Lymphoblastic Leukemia, in Relapse
Status: Recruiting
http://inclinicaltrials.com/acute-lymphoblastic-leukemia-in-relapse/NCT04605666/
Blinatumomab for Minimal Residual Disease Before Hematopoietic Stem Cell Transplantation With Pediatric B-cell Precursor Acute Lymphoblastic Leukemia
This is a single-arm, open-label, multi-center phase I study using blinatumomab for pediatric B-cell acute lymphoblastic leukemia patients with positive of minimal residual disease. 1 Cycle of blinatumomab treatment followed by hematopoietic stem cell transplantation. Blinatumomab has approved to treat adults and children with B-cell precursor ALL who are in remission but still have MRD. However, data on the effects and safety of blinatumomab in children with B-precursor ALL with MRD positive are insufficient.
NCT04604691 — Minimal Residual Disease
Status: Recruiting
http://inclinicaltrials.com/minimal-residual-disease/NCT04604691/
Intraocular Pressure in Children With ALL Treated With High Dose Steroids
Childhood ALL patients are treated with high dose steroids. The study will follow the intraocular pressure of children treated in according to an AIEOP-BFM protocol, during the induction phase that will be compared to the pressure before treatment. Potential risk factors for developing elevated intraocular pressure will be estimated.
NCT04593745 — ALL, Childhood
Status: Recruiting
http://inclinicaltrials.com/all-childhood/NCT04593745/
Blinatumomab Bridging Therapy in High-Risk B-Acute Lymphoblastic Leukemia: A Phase 2 Study
The investigator is testing the ability of a biologically active therapy in blinatumomab, an anti-CD19/CD3 bispecific T-cell engager, to further reduce residual leukemia immediately prior to HCT to improve post-HCT outcomes.
NCT04556084 — B-cell Acute Lymphoblastic Leukemia
Status: Recruiting
http://inclinicaltrials.com/b-cell-acute-lymphoblastic-leukemia/NCT04556084/
Single Cycle of Blinatumomab Followed by High-dose Chemotherapy in the Induction Therapy for Ph-negative Acute Lymphoblastic Leukemia in Adults
This is a phase II interventional trial to evaluate the efficacy of blinatumomab followed by high-dose chemotherapy in the first-line treatment for Ph-negative acute lymphoblastic leukemia (ALL) in adults. The aim is to increase the number of complete molecular responses after first two cycles of therapy. Early molecular response is considered to be the most powerful prognostic factor in ALL. Thus, a higher proportion of early molecular responses should translate into improved survival and fewer indications for allogeneic stem cell transplants
NCT04554485 — Newly Diagnosed
Status: Completed
http://inclinicaltrials.com/newly-diagnosed/NCT04554485/
Assesment of JL1 Expression in B-cell Acute Lymphoblastic Leukemia
The aim of this study is to assess JL1 expression by flow cytometric immunophenotyping in patients with B-cell Acute Lymphoblastic Leukemia (ALL) and to correlate it with clinical, morphological, immunophenotypic, cytogenetic data and response to treatment.
NCT04554381 — Acute Lymphoblastic Leukemia
Status: Not yet recruiting
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT04554381/
Safety and Efficacy Study of CD22 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia
This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD22 CAR-T cell in the treatment of recurrent or refractory B-ALL
NCT04546906 — B-ALL
Status: Recruiting
http://inclinicaltrials.com/b-all/NCT04546906/
A Phase 1/2 Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)
The study aims to evaluate the safety, efficacy, and tolerability of subcutaneous (SC) blinatumomab for treatment of Acute Lymphoblastic Leukemia (ALL), to determine the maximum tolerated dose (MTD), and recommended phase 2 dose(s) (RP2D) of SC administered blinatumomab. It will also conduct a clinical PK evaluation of SC1 and SC2 blinatumomab formulations.
NCT04521231 — B Cell Precursor Acute Lymphoblastic Leukemia
Status: Recruiting
http://inclinicaltrials.com/b-cell-precursor-acute-lymphoblastic-leukemia/NCT04521231/
Effect of Vitamin D Administration on Methotrexate Adverse Effects in Patients With Acute Lymphoblastic Leukemia
Since methotrexate toxicity represents a major problem in patients treating with cancer and there are few studies about the role of vitamin D in the pathogenesis of this toxicity, so the aim of the present study is investigation of the effect of vitamin D administration on methotrexate toxicity such as oral ulcerations, bone marrow toxicity as well as renal and hepatic toxicity also the role of inflammatory mediators and oxidative stress markers in methotrexate toxicity will be evaluated, taking in consideration the dose of leucovorin rescue.
NCT04488237 — Acute Lymphoblastic Leukemia
Status: Not yet recruiting
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT04488237/