Raman Spectroscopy Compared to Flow Cytometry as a Method for Assessing Measurable Residual Disease in Patients With Acute Lymphoblastic Leukemia
The detection of MRD is associated with an increased risk of relapse and adverse prognosis in all patient groups diagnosed with acute lymphoblastic leukemia (ALL). However, it has a sensitivity level that detects one leukemic cell in 10,000 normal cells, along with other disadvantages such as the need for a panel of fluorescent antibodies for MRD detection, and its measurement is not standardized in many centers. New determination techniques may be necessary for MRD evaluation. Raman spectroscopy is proposed as a potential technique for MRD measurement, which is based on the inelastic scattering of light that occurs when it interacts with matter, causing optical scattering, where a portion of the radiation changes its wavelength (by Raman effect). Objectives: MAIN OBJECTIVE: To evaluate the presence of MRD in patients with ALL by comparing a standard evaluation method using flow cytometry with a new proposed method using Raman spectroscopy. SPECIFIC OBJECTIVES: - To assess the presence of MRD using flow cytometry in patients with ALL. - To assess the presence of MRD using Raman spectroscopy in patients with ALL. - To perform a comparison between the MRD measurement techniques by determining sensitivity, specificity, positive predictive value, and negative predictive value. - To establish the validation of using Raman spectroscopy as a method for MRD evaluation. Study Design: An observational, cross-sectional, comparative, and diagnostic test study will be conducted on bone marrow aspirate samples from adult and pediatric ALL patients to evaluate the presence of MRD using Raman spectroscopy, comparing the results of this technique with those obtained using flow cytometry. As a diagnostic test study, sensitivity, specificity, positive predictive value, and negative predictive value will be evaluated. The study will be conducted on adult and pediatric patients diagnosed with acute lymphoblastic leukemia treated at the hemato-oncology department of the UMAE No. 1 National Medical Center Bajio and the UMAE Hospital Gynecology-Pediatrics No. 48. Inclusion Criteria: Patients diagnosed with ALL for whom MRD determination is clinically necessary will be included in the study. Their results will be evaluated using the gold standard, flow cytometry, and compared with results obtained through Raman spectroscopy.
NCT06291428 — Acute Lymphoblastic Leukemia
Status: Not yet recruiting
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT06291428/
A Phase 2 Multicenter Study Evaluating the Safety and the Efficacy of KTE-X19 in Adult Japanese Subjects With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
The goal of this clinical study is to learn more about KTE-X19, and how safe and effective it is in adult Japanese participants with relapsed/refractory (r/r) Mantle Cell Lymphoma (MCL) or r/r B-precursor Acute Lymphoblastic Leukemia (B-ALL). The primary objectives of this study are to evaluate the efficacy of KTE-X19, as measured by: - Objective response rate (ORR) per investigator assessment, in adult Japanese participants with r/r MCL - Overall complete remission (OCR) defined as complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) per investigator assessment, in adult Japanese participants with r/r ALL
NCT06253663 — Relapsed/Refractory Mantle Cell Lymphoma
Status: Recruiting
http://inclinicaltrials.com/relapsed-refractory-mantle-cell-lymphoma/NCT06253663/
Daratumumab in Very High-Risk T-Lineage Acute Lymphoblastic Leukemia (ALL) Treated According to the ALL National Treatment Program (DARATALL-VHR)
The goal of this clinical trial is to test daratumumab in adult very high risk T-lineage lymphoblastic leukemia. The main question it aims to answer is wether the addition of daratumumab daratumumab to the national standard of care is able to increase the rate of MRD-negative patients after induction therapy. Participants will be treated with: • daratumumab in combination with a pediatric-inspired treatment scheme - as in the previous GIMEMA LAL1913 protocol.
NCT06253637 — T-Lymphocytic Leukemia, Acute
Status: Not yet recruiting
http://inclinicaltrials.com/t-lymphocytic-leukemia-acute/NCT06253637/
Treatment of CD19 Chimeric Antigen Receptor T Cells for Pediatric Patients With CD19-positive B-cell Acute Lymphoblastic Leukemia Who Are Indicated for Hematopoietic Stem Cell Transplantation
This is a phase 2 clinical trial targeting pediatric and adolescent patients diagnosed with CD19-positive B-ALL, considered very high-risk group. The study aims to administer CD19 CAR-T therapy as an alternative to hematopoietic stem cell transplantation in patients eligible for such transplantation. The trial includes patients aged 25 or younger.
NCT06247501 — Very High Risk Acute Lymphoblastic Leukemia
Status: Recruiting
http://inclinicaltrials.com/very-high-risk-acute-lymphoblastic-leukemia/NCT06247501/
A Single-arm, Open-label Study of Olverembatinib, CD3/CD19 Bispecific T-cell Engager, and Chidamide in Patients With Newly Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
ABC study is a phase 2, single-arm, open-label study of Olverembatinib, CD3/CD19 Bispecific T-cell Engager, and Chidamide in patients with newly diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ALL). This study combined third generation TKI (Olverembatinib), histone deacetylase inhibitors (Chidamide) and CD3/CD19 bispecific T-cell engager (Blinatumomab) as first line regimen (ABC regimen) for Ph+ ALL. Investigatorsaim to explore the efficacy and safety of ABC regimen. The primary endpoint is the complete molecular remission （CMR） at 3 months, secondary endpoints are overall survival (OS), event-free survival (EFS), adverse event (AE), IKZF1del, IKZF1plus, IKZF1lpus/CD20 subgroup EFS/OS.
NCT06220487 — Acute Lymphoblastic Leukemia
Status: Recruiting
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT06220487/
The Role of Natural Killer Cell Profiling in Predictions of Blood Stream Infection and Antibiotic Resistance in Acute Lymphoblastic Leukemia Patients Post Chemotherapy.
1. Assess possibility of prediction of blood stream infections in ALL patients by profiling of NK cells using flow cytometry. 2. Assess the role of NK cells in development of drug resistance post chemotherapy.
NCT06160115 — Acute Lymphoblastic Leukemia
Status: Not yet recruiting
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT06160115/
Phase 2 Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL)
This is a Phase 2 Study is to determine the efficacy and safety rate of B-Cell Acute Lymphoblastic Leukemia (B-ALL) participants in remission with minimal residual disease (MRD) after KTE-X19 CAR T-cell therapy
NCT06144606 — Acute Lymphoblastic Leukemia
Status: Recruiting
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT06144606/
Evaluation of the Advantage in the Use of Enteral Nutrition in Children Treated for Acute Lymphoblastic Leukemia
This is a multicenter retrospective study (Reims and Nancy), with data collection over 12 years from 01/01/2010 to 12/31/2022 Patients included are children diagnosed with acute lymphoblastic leukemia between 2010 and 2021 in the 2 centers. Patients will be categorized into 3 groups: - No nutritional support - Support by enteral nutrition - Parenteral nutrition support Their nutritional status will be assessed at the end of induction, at 6 months and then at 12 months from diagnosis. The main objective of this study is therefore to compare the nutritional status of children with acute lymphoblastic leukemia depending on whether they received enteral or parenteral nutritional support during their treatment. The secondary objective is to evaluate the occurrence of complications during treatment according to the nutritional support received.
NCT06110182 — Leukemia, Lymphoblastic
Status: Active, not recruiting
http://inclinicaltrials.com/leukemia-lymphoblastic/NCT06110182/
CD19-directed CAR-T Cell Therapy for Refractory or Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma: a Multicenter Phase I/II Trial.
The goal of this prospective, multicentric, single-arm, phase I/II clinical trial is to evaluate the safety and efficacy of a novel CD19-directed CAR-T cell locally produced in an academic institution in Brazil in patients with refractory or relapsed acute lymphoblastic leukemia or non-Hodgkin lymphoma. Participants will receive a single intravenous infusion of an autologous academic anti-CD19 CAR-T cell and will be followed for 5 years.
NCT06101381 — Lymphoma, Non-Hodgkin
Status: Not yet recruiting
http://inclinicaltrials.com/lymphoma-non-hodgkin/NCT06101381/
iMagINg of Chemotherapy-Induced Morphological and Functional Lung Changes in Childhood Acute Lymphoblastic Leukemia and Hodgkin's Disease
With increasing cure rates of childhood cancer there is growing recognition of late effects of treatments. However, there is a lack of non-invasive and child-friendly procedures that can indicate possible late damage. This study uses morphologic and free-breathing phase-resolved functional low-field (PREFUL) magnetic resonance imaging (MRI) to identify persistent pulmonary toxicity after treatment for childhood acute lymphoblastic leukemia (ALL), Hodgkin's disease (HD) and allogeneic stem cell transplantation. Furthermore, cardiopulmonary testing is performed by means of a pulmonary function test, echocardiography with strain analysis and spiroergometry.
NCT06093334 — Acute Lymphoblastic Leukemia
Status: Recruiting
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT06093334/