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Leukemia, Lymphoid clinical trials

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NCT ID: NCT06393985 Not yet recruiting - Clinical trials for B-cell Acute Lymphoblastic Leukemia

Decitabine, Venetoclax and Blinatumomab for Maintenance Following HSCT in Patients With Ph-Negative B-ALL

Start date: April 25, 2024
Phase: Phase 2
Study type: Interventional

This study aims to evaluate whether maintenance therapy with decitabine, venetoclax and blinatumomab could improve the 2-year progression free survival (PFS) of patients with philadelphia chromosome-negative B-cell acute lymphoblastic leukemia who had recently received an allogeneic stem cell transplant and in measurable residual disease-negative remission.

NCT ID: NCT06390319 Not yet recruiting - T-cell Lymphoma Clinical Trials

Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)

Start date: May 2024
Phase: Phase 2
Study type: Interventional

This is a clinical trial testing whether the addition of one of two chemotherapy agents, dasatinib or venetoclax, can improve outcomes for children and young adults with newly diagnosed T-cell acute lymphoblastic leukemia and lymphoma or mixed phenotype acute leukemia. Primary Objective - To evaluate if the end of induction MRD-negative rate is higher in patients with T-ALL treated with dasatinib compared to similar patients treated with 4-drug induction on AALL1231. - To evaluate if the end of induction MRD-negative rate is higher in patients with ETP or near-ETP ALL treated with venetoclax compared to similar patients treated with 4-drug induction on AALL1231. Secondary Objectives - To assess the event free and overall survival of patients treated with this therapy. - To compare grade 4 toxicities, event-free survival (EFS) and overall survival (OS) of patients treated with this therapy in induction and reinduction to toxicities of similar patients treated on TOT17.

NCT ID: NCT06389305 Not yet recruiting - Clinical trials for B-cell Acute Lymphoblastic Leukemia

CIK Cell Therapy for Relapsed or Refractory Acute B-Lymphoblastic Leukemia: Prognostic Impact on Patients With Early CAR-T Cell Dysfunction

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

This is a single-center, double-blind, randomized trial. Patients with relapsed or refractory acute B-lymphoblastic leukemia(r/r B-ALL) experiencing early functional exhaustion of CAR-T cells will be randomly allocated into three groups: the control cell group, the CIK treatment group, and the messenger RNA(mRNA)-CIK treatment group. The primary objective of the study is to evaluate the prognostic impact of CIK cell therapy on the early functional exhaustion of CAR-T cells in children and adolescent and young adult (AYA) with r/r B-ALL. The primary endpoint of the study is the event-free survival rate of these patient in the CIK cell therapy group.A total number of 213 subjects will be enrolled.

NCT ID: NCT06387121 Not yet recruiting - Clinical trials for Precursor Cell Lymphoblastic Leukemia-Lymphoma

Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Elderly/Unfit Ph- B-ALL

Start date: April 15, 2024
Phase: Phase 2
Study type: Interventional

In the treatment of Ph-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL), despite the achievements of chemotherapy and immunotherapy, the therapeutic outcomes are unsatisfactory in elderly or unfit patients. In recent years, tumor immunotherapy has demonstrated a high safety and efficacy profile in refractory Ph- B-ALL patients. These findings suggest that the advancement of immunotherapy application may be an important approach to improve patient survival. In this study, we propose a treatment approach that combines immuno-targeted drugs with low-dose chemotherapy for newly diagnosed elderly or unfit patients with Ph- B-ALL, aiming to enhance the measurable residual disease (MRD)-negative complete remission (CR) rate measured through flow cytometry following induction therapy, reduce the risk of relapse, and ultimately improve patients' overall survival.

NCT ID: NCT06378138 Not yet recruiting - Clinical trials for Hematologic Malignancies

ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Start date: April 25, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

NCT ID: NCT06367374 Not yet recruiting - Clinical trials for Chronic Lymphocytic Leukemia

MRD Guided Sonrotoclax and Zanubrutinib in Newly Diagnosed CLL/SLL

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

This is a single-arm, open-label study of sonrotoclax plus zanubrutinib with MRD-driven treatment duration in patients with previously untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). The primary goal of this study is to evaluate the efficacy of MRD-guided zanubrutinib plus sonrotoclax for first-line CLL/SLL treatment.

NCT ID: NCT06367114 Not yet recruiting - Clinical trials for Relapsed or Refractory Acute Lymphoblastic Leukemia

Clinical Trial of ssCART-19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (Including Central Nervous System Infiltration)

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

This study is a Phase II, single-arm, open-label, non-randomized, dose-escalation clinical trial to evaluate the efficacy and safety of ssCART-19 Cell Injection in the treatment of patients with CD19 positive Relapsed or Refractory acute lymphoblastic leukemia, including central nervous system infiltration.

NCT ID: NCT06364423 Not yet recruiting - Clinical trials for B-Cell Chronic Lymphocytic Leukemia

Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for Chronic Lymphocytic Leukemia (CLL)

Start date: May 8, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are blood cancers that affect certain white blood cells. Advanced forms of these diseases are difficult to treat. CD19 is a protein often found on the surfaces of these cancer cells. Researchers can modify a person's own immune cells (T cells) to target CD19. When these modified T cells are returned to the body-a treatment called anti-CD19 chimeric antigen receptor (CAR) T cell therapy-they may help kill cancer cells. Objective: To test anti-CD19 CAR T cell therapy in people with CLL or SLL. Eligibility: People aged 18 years and older with CLL or SLL that has not been controlled with standard drugs. Design: Participants will be screened. They will have imaging scans and tests of their heart function. If a sample of tissue from their tumor is not available, a new one may be taken; the sample will be tested for CD19. Participants will receive a drug to reduce the leukemia cells in their blood. Then they will undergo apheresis: Blood will be taken from the body through a needle. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different needle. The collected T cells will be gene edited to make them attack cells with CD19. Participants will take drugs to prepare them for treatment for 3 days. These drugs will start 5 days before the treatment. Then their own modified CAR T cells will be returned to their bloodstream. Participants will stay in the hospital for at least 9 days after the treatment. Follow-up visits will continue for 5 years.

NCT ID: NCT06364033 Not yet recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Biological and Clinical Efficacy of Shingrix in Patients With CLL

Start date: August 2024
Phase: N/A
Study type: Interventional

This is a biological study. Patients who are eligible to receive Shingrix through the Italian National Health System will be invited to participate in the study. According to AIFA indication, the two doses of vaccine will be administered 4-8 weeks apart. Blood samples will be collected prior to the first vaccine dose (i.e. within the time frame of 3 months prior to the first dose) and 1, 6, 12, 24 and 36 months after the second vaccine dose to evaluate the serological response of Shingrix.

NCT ID: NCT06343376 Not yet recruiting - Clinical trials for Recurrent Mantle Cell Lymphoma

Genetically Engineered Cells (EGFRt/19-28z/IL-12 CAR T Cells) for the Treatment of Relapsed or Refractory CD19+ Hematologic Malignancies

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

This phase I trial tests the safety, side effects, and best dose of genetically engineered cells called EGFRt/19-28z/IL-12 CAR T cells, and to see how they work in treating patients with hematologic malignancies that makes a protein called CD19 (CD19-positive) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Chimeric Antigen Receptor (CAR) T-cell Therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. To improve the effectiveness of the modified T cells and to help the immune system fight cancer cells better, the modified T cells given in this study will include a gene that makes the T cells produce a cytokine (a molecule involved in signaling within the immune system) called interleukin-12 (IL-12). The researchers think that IL-12 may improve the effectiveness of the modified T cells, and it may also strengthen the immune system to fight cancer. Giving EGFRt/19-28z/IL-12 CAR T cells may be safe and tolerable in treating patients with relapsed or refractory CD19+ hematologic malignancies.