Effectiveness of Laser Therapy of Different Wavelengths in Chemotherapy Induced Oral Mucositis in Children With Acute Lymphoblastic Leukemia
Introduction: Oral mucositis is one of the most frequent complications associated with chemotherapy, occurring in up to 90% children receiving treatment for cancer. Different treatment modalities have been suggested with inconsistent results. Recently, it has been suggested that the use of laser could reduce the grade of oral mucositis and alleviate the symptoms. Aim: To evaluate and compare the efficacy between the high (Infrared) wavelength laser and low (red) wavelength laser in management of chemotherapy induced oral mucositis in children with acute lymphoblastic leukemia. Methods: This study is a randomized, prospective, double-blind trial that will include acute lymphoblastic leukemia inpatients receiving induction chemotherapy between the age of 3 and 14years who develop oral mucositis grade 2 or more. These patients will be randomized by the Clinical Epidemiology unit using a computer-based method into three groups. Group I: will be treated with Laser wavelength 660 nm, group II: will be treated with laser wavelength 970 nm, and group III: will receive mock treatment which is the exact repetition of the treatment modality but without any laser emission. All the patients will follow the hospital standard management for oral mucositis. All patients will be assessed for pain score using CHIMES, oral mucositis using NCI-CTCAE scale V5 on days, 0,4,7 and 11. As well as measuring the duration of the lesion.
NCT05452668 — Oral Mucositis
Status: Recruiting
http://inclinicaltrials.com/oral-mucositis/NCT05452668/
Family-Based Behavioral Treatment for Childhood Survivors of Acute Lymphoblastic Leukemia
A single-arm, non-randomized four-month trial of the adapted family-based behavioral weight loss treatment (FBT) intervention will be conducted to evaluate its acceptability, feasibility, and preliminary indications of efficacy including measures of relative weight change and associated secondary outcomes (e.g., weight related health behaviors, health related quality of life), among 40 childhood acute lymphoblastic leukemia (ALL) survivors and their families.
NCT05410574 — Acute Lymphoblastic Leukemia
Status: Terminated
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT05410574/
Venetoclax in Combination With Asparaginase-Containing Pediatric-Inspired Chemotherapy in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
The researchers are doing this study to find out whether combining venetoclax with several different standard chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) in children is safe and effective in adults with newly diagnosed ALL. Participants in this study will be under the age of 60, and they will have T- or B-cell ALL.
NCT05386576 — Acute Lymphoblastic Leukemia
Status: Active, not recruiting
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT05386576/
Effect of Metformin on ABCB1 and AMPK Expression in Adolescents With Newly Diagnosed Acute Lymphoblastic Leukemia
Acute lymphoblastic leukemia, is the most frequent cancer in children and adolescents. Some genes have been described to produce drug resistance, as ABCB1 probably by lack of activation of AMPK. Some manuscripts have shown that metformin has antitumoral activity, mainly by activation of AMPK. This is an experimental one center trial, that pretend analyze the effect of metformin at a dose of 1000mgm2 per day, on the expression of the ABCB1 and AMPK genes, when is added to conventional induction remission chemotherapy in newly diagnosed adolescents with acute lymphoblastic leukemia.
NCT05326984 — Acute Lymphoblastic Leukemia
Status: Recruiting
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT05326984/
Combination of Ponatinib Plus Chemotherapy As Frontline Treatment For Patients With BCR/ABL1-Like Acute Lymphoblastic Leukemia (BCR/ABL1-Like ALL)
Acute lymphoblastic leukemia (ALL) is the most frequent cancer in children, decreases in adolescence and adulthood, and a second peak can be recorded starting from the 6th decade of life. While the outcome in children is excellent, in the adolescent/adult population, the prognosis, though improved over the decades, it is still unsatisfactory and novel biologically-driven approaches are urgently needed. In this setting, thanks to the introduction of genome wide technologies, it was possible to recognize specific subset of ALL. Among those, the BCR/ABL1-like ALL are of extreme importance, since they are characterized by an unfavourable outcome and, on the other hand, can benefit of a targeted treatment, in particular with the pan-tyrosine kinase inhibitor ponatinib. The primary objective is to evaluate the clinical response - in terms of MRD negativity - in patients with a BCR/ABL1-like profile, according to the BCR/ABL1-like predictor tool, treated with Ponatinib in combination with chemotherapy.
NCT05306301 — Chemotherapy
Status: Recruiting
http://inclinicaltrials.com/chemotherapy/NCT05306301/
CD7 CAR-T Cell Treatment of Relapsed/Refractory CD7+ T -Acute Lymphoblastic Leukemia/ Lymphoma
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD7 CAR-T cells in patients with relapsed and/or refractory, high risk hematologic malignancies.
NCT05212584 — T-ALL/Lymphoma
Status: Recruiting
http://inclinicaltrials.com/t-all-lymphoma/NCT05212584/
A Phase Ib, Clinical Trial of Hospital-manufactured CD19 Chimeric Antigen Receptor T Cells (SNUH-CD19-CAR-T) in Children and Adolescents With Relapsed or Refractory CD19 Positive Acute Lymphoblastic Leukemia
Chimeric antigen receptor T cells (CAR-T cells) have been developed to treat relapsed and refractory hematological malignancies with promising outcome in patients with very poor prognosis. The purpose of this clinical study is to produce the CD19[cluster of differentiation antigen 19] CAR-T (SNUH-CD19-CAR-T) at the investigational site and to evaluate safety and efficacy of SNUH-CD19-CAR-T in children and adolescent with relapsed/refractory B-cell acute lymphoblastic leukemia.
NCT05210907 — B-cell Acute Lymphoblastic Leukemia
Status: Recruiting
http://inclinicaltrials.com/b-cell-acute-lymphoblastic-leukemia/NCT05210907/
RAVEN: A Phase I/II Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax
This is a phase I/II clinical trial evaluating the activity of combination chemotherapy with venetoclax and navitoclax in children with relapsed or refractory acute lymphoblastic leukemia or lymphoma (rALL) and assessing the combination dose of venetoclax combinations with either blinatumomab for CD19-postive patients or navitoclax and high-dose cytarabine for CD19-negative patients. Primary Objectives - To compare Minimal Residual Disease (MRD)-negative CR/CRi rate in children with relapsed or refractory acute lymphoblastic leukemia or lymphoma (rALL) following Block 1 therapy with venetoclax and navitoclax based reinduction to historical controls. - To identify the recommended phase 2 combination dose (RP2D) of venetoclax based consolidation in novel combinations with a) high-dose cytarabine and navitoclax or b) blinatumomab. Secondary Objectives - To estimate the tolerability and activity of venetoclax based consolidation in novel combinations with a) high-dose cytarabine and navitoclax or b) blinatumomab. - To describe event-free and overall survival in patients treated with this regimen. Exploratory Objectives - To evaluate MRD-negative CR/CRi rates in each prespecified groups: late first relapse B-ALL; early first relapse and second or greater relapse B-ALL; and relapsed T-ALL. - To identify drug sensitivity patterns in patient samples prior to and after receiving combination therapy and evaluate mechanisms of disease resistance/ escape. - To explore immune subsets during and after this regimen. - Evaluate response to therapy in rare relapse patient subsets. - Explore breakthrough infections in children and young adults with relapsed or refractory ALL
NCT05192889 — Refractory Acute Lymphoblastic Leukemia
Status: Active, not recruiting
http://inclinicaltrials.com/refractory-acute-lymphoblastic-leukemia/NCT05192889/
Phase I, Open Label, Multicenter, Dose Escalation and Expansion Study of IMJ995 in Acute Lymphoblastic Leukemia
This is a first-in-human study to evaluate the feasibility, safety and preliminary antitumor efficacy of autologous chimeric antigen receptor (CAR) T cells targeting both CD19 and CD22, manufactured with T-Charge(TM) process. CAR-T cells will be investigated as single agent in pediatric and adult acute lymphoblastic leukemia (ALL).
NCT05168748 — Acute Lymphoblastic Leukemia
Status: Withdrawn
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT05168748/
Allogeneic CD19 CAR-T Cells for the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
CD19 CAR-T has been widely developed in patients with R/R ALL and has also been generally recognized by the industry. In 2017, the U.S. FDA approved Novartis's CD 19 CAR-T product Kymriah for the treatment of R/R ALL. However, these CAR-T cells are constructed from patients' autologous T cells, and the production and preparation time is long; on the other hand, most patients have received multiple chemotherapy before CAR-T treatment, and the quantity and quality of T cells often cannot meet the needs of clinical treatment. It is also an important factor leading to the failure of CAR-T cell therapy, which limits the large-scale clinical application of CAR-T. T cells derived from healthy donors are not only sufficient in quantity and quality guaranteed, but also available at any time. In December 2020, lancet reported a clinical study of 19 patients receiving allogeneic CAR-T cell ALL. 14 patients were evaluated as CR/CRi (67%) 28 days after treatment, and the median sustained remission time was 4.1 moon. Allogeneic CAR-T cells are safe and effective for the treatment of ALL, and their clinical application range is expected to improve the remission rate and survival rate of patients with R/R ALL.
NCT05164042 — Refractory Leukemia
Status: Recruiting
http://inclinicaltrials.com/refractory-leukemia/NCT05164042/