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Leukemia, Lymphoid clinical trials

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NCT ID: NCT06336395 Recruiting - Clinical trials for B Lymphoblastic Leukemia

Ma-Spore ALL 2020 Study

Start date: March 4, 2020
Phase: Phase 2
Study type: Interventional

The primary objective of this trial is to improve the overall survival rate of children and young adult with B-lineage acute lymphoblastic leukemia (B-ALL) in Singapore and Malaysia in the context of a multicenter cooperative trial using a risk-stratified therapy.

NCT ID: NCT06334835 Recruiting - Clinical trials for Acute Lymphoblastic Leukemia, Pediatric

Long Non-coding RNAs and Their Role on Epigenome as Diagnostic Markers in Childhood Acute Lymphoblastic Leukemia of T Cells.

Start date: April 30, 2023
Phase:
Study type: Observational

Long non-coding RNAs (lncRNAs) are a class of biomarkers of crescent interest in the hematologic and oncologic field. They do not encode proteins and can alter gene expression by acting on different steps of regulation, including DNA methylation and chromatin structure. Recent data identified recurrent somatic alterations in genes involved in DNA methylation and post-translational histone modifications in T-ALL, suggesting that epigenetic homeostasis is critically required in restraining tumor development in the T-cell lineage. Further, recent studies showed that the expression levels of specific lncRNAs correlate with the prognosis of patients with Acute Lymphoblastic Leukemia of T-cells (T-ALL). The objectives of this research project are to identify T-ALL-specific lncRNAs to be used as new diagnostic and prognostic biomarkers of disease and to explore their role on chromatin reorganization and transcriptional regulation that may lead to the onset and progression of T-ALL.

NCT ID: NCT06333262 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia

Start date: April 22, 2024
Phase: Phase 2
Study type: Interventional

This study will evaluate fixed-duration therapy with pirtobrutinib and obinutuzumab given over 12 cycles (approximately 1 year) as first-line treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL or SLL).

NCT ID: NCT06326008 Not yet recruiting - Clinical trials for B-cell Acute Lymphoblastic Leukemia

Safety, Tolerability, and Pharmacokinetics of Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy for r/r B-ALL: a Clinical Trial

Start date: April 15, 2024
Phase: Phase 1
Study type: Interventional

This is an investigator-initiated, single-arm, open-label, non-randomised phase I clinical study. The objective of this trial is to evaluate the safety, tolerability and pharmacokinetics of donor-derived CD19 CAR Therapy bridged Allo-HSCT and sequential donor-derived CD22 CAR Therapy for r/r B-ALL and to explore the efficacy of this therapy preliminarily. The primary endpoints are incidence and type of dose-limiting toxicity (DLT) within 28 days (i.e., 43 days after donor-derived CD19 CAR T-cell infusion) after donor-derived CD19 CAR T-cell therapy bridged allogeneic haematopoietic stem cell transplantation; total number, incidence and severity of adverse events from donor-derived CD19 CAR T cell infusion back to 30 days after donor-derived CD22 CAR T cell infusion (i.e., within 120 days of donor-derived CD19 CAR T cell infusion). The secondary endpoints are total number, incidence and severity of adverse events from 120 days to 2 years after donor-derived CD19 CAR T-cell infusion; ORR(CR+CRi) on days 45, 90, 120; duration of response(DOR), event-free survival(EFS), overall survival(OS); pharmacokinetics characteristics. The trial plan to enroll 3~12 cases in dose escalation phase and 36 cases in dose expansion phase.

NCT ID: NCT06317662 Not yet recruiting - Clinical trials for B Acute Lymphoblastic Leukemia

Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia

Start date: July 31, 2024
Phase: Phase 2
Study type: Interventional

This phase II trial tests the addition of venetoclax and/or blinatumomab to usual chemotherapy for treating infants with newly diagnosed acute lymphoblastic leukemia (ALL) with a KMT2A gene rearrangement (KMT2A-rearranged [R]) or without a KMT2A gene rearrangement (KMT2A-germline [G]). Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding venetoclax and/or blinatumomab to standard chemotherapy may be more effective at treating patients with ALL than standard chemotherapy alone, but it may also cause more side effects. This clinical trial evaluates the safety and effectiveness of adding venetoclax and/or blinatumomab to chemotherapy for the treatment of infants with KMT2A-R or KMT2A-G ALL.

NCT ID: NCT06316856 Not yet recruiting - Clinical trials for Refractory Acute Lymphoblastic Leukemia

CD5 Chimeric Antigen Receptor (CAR) T Cells in Subjects With Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia

Start date: April 20, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a single-center, open-label, non-randomized, phase 1/2 study of anti-CD5 CAR-T cell therapy in patients with CD5+ relapsed or refractory T-cell malignancies. A bayesian optimal interval (BOIN) 12 design will be used to explore the optimal biological dose (OBD) from starting dose level 1: 1×10^6 (±20%) to dose level 2: 2×10^6 (±20%) in three cohorts (autologous, previous-transplant-donor or newly matched donor-derived CD5 CAR T cells). If the manufactured cells are not sufficient to meet the preassigned standard dose criteria, patients will be given infusion at a low dose level of 5×10^5 (±20%) /kg. The primary objective is to evaluate the safety and tolerability of CD5 CAR T cell therapy in subjects, determine the OBD and recommend phase 2 dose (RP2D) in phase 1, and evaluate the efficacy of CD5 CAR T cell therapy in phase 2. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days, and the incidence and severity of adverse events (AEs) within 30 days after CD5 CAR T-cell infusion in phase 1, the best overall response (BOR) at 3 months (± 1 week) after CD5 CAR T-cell infusion in phase 2. A total number of 54 subjects will be enrolled.

NCT ID: NCT06316427 Recruiting - Clinical trials for Refractory Acute Lymphoblastic Leukemia

Autologous and Donor-derived CD7 CAR-T Therapy in Refractory or Relapsed T-cell Acute Lymphoblastic Leukemia/Lymphoma

Start date: March 22, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a single-center, open-label, non-randomized, phase I/II trial. Patients with refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) will receive autologous, prior-HSCT donor-derived or new donor-derived CD7 CAR T cells according to their HSCT history, peripheral blood leukemia burden and at their discretion. The primary objective is to learn about the safety of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r/r T-ALL/T-LBL) in phase I and to learn about the efficacy of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r/r T-ALL/T-LBL) in phase II. The primary endpoint is type and incidence of dose limiting toxicity (DLT) within 21 days after CD7 CAR T-cell infusion in phase I and overall response rate (ORR), which includes CR, CRh, CRi, MLFS, aplastic marrow for blood and bone marrow; central nervous system (CNS) remission; CR and PR for lymphomatous extramedullary disease according to National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2023 of Acute Lymphoblastic Leukemia at 3 months (± 1 week) post CD7 CAR T-cell infusion in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells in phase II. A total number of 80 subjects will be enrolled.

NCT ID: NCT06308588 Not yet recruiting - Clinical trials for Acute Lymphoblastic Leukemia

Phase II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Start date: September 30, 2024
Phase: Phase 2
Study type: Interventional

To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.

NCT ID: NCT06307600 Not yet recruiting - Clinical trials for B Lymphoblastic Leukemia/Lymphoma

The Safety and Efficacy of RD06-03 CART Cell Injection in Patients With R/R Acute B-lymphoblastic Leukemia

Start date: March 15, 2024
Phase: Early Phase 1
Study type: Interventional

This study is designed to explore the safety and efficacy for patients with relapsed and/or refractory B-cell lymphoblastic leukemia.

NCT ID: NCT06299540 Not yet recruiting - Clinical trials for Leukemia, Lymphocytic, Chronic, B-Cell

Benefits of Individual Physical Activity Intervention on Health-related Quality of Life in Participants With Chronic Lymphocytic Leukemia

QOLIBRI
Start date: April 30, 2024
Phase:
Study type: Observational

The purpose of this study is to assess the impact of an individual physical activity intervention (IPAI) on health-related quality of life (HRQoL) in participants with first line or relapsed chronic lymphocytic leukemia (CLL) initiating ibrutinib in a routine clinical practice setting. HRQoL will be measured using functional assessment of cancer therapy - general scale (FACT-G).