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Leukemia, Lymphoid clinical trials

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NCT ID: NCT05598593 Recruiting - Clinical trials for T Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma

Modified TBF Regimen as Conditioning Regimen Prior to Allo-HSCT for T-ALL/LBL

Start date: October 23, 2022
Phase: Phase 2
Study type: Interventional

T cell acute lymphoblastic leukemia (T-ALL)/Lymphoblastic lymphoma (LBL) is a hematological malignancy caused by malignant transformation and clonal expansion of T-lineage precursor cells. The long-term cure rate of pediatric patients with T-ALL/LBL reaches 90%, but long-term survival of adult patients is less than 60%. Moreover, patients with high-risk factors such as PTEN/NRAS gene mutation, early T cell precursor (ETP) phenotype or positive minimal residual disease (MRD) have high rates of chemoresistance and dismal outcome. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) can significantly improve the prognosis of high-risk T-ALL/LBL. Total body irradiation (TBI)-based conditioning chemotherapy regimen is the preferred regimen for allo-HSCT in children and young adults with ALL because of lower relapse rates and satisfactory survival. Different from children, the non-relapse-related mortality (NRM) after TBI-based preconditioning in adults (especially those >35 years old) was reported as high as 38%. In addition, serious sequelae after TBI seriously affect the quality of life and non-radiation conditioning chemotherapy regimens are urgently needed for T-ALL/LBL. The reported recurrence rates after BUCY (busulfan + cyclophosphamide) conditioning regimen for T-ALL as 41.2%. -56.7% and long-term survival was only 30-50%. Thiotepa is an ethyleneimine alkylating agent with anti-tumor effects and immunosuppressive effects, thus is widely used in conditioning regimen before HSCT. Retrospective paired analysis from EBMT indicated conditioning regimen thiotepa achieved similar relapse rates, long-term survival and faster granulocyte and platelet engraftment than TBI regimen. A recent retrospective study of childhood ALL from Turkey also reported that the TBF(thiotepa + fludarabine + busulfan) regimen had a recurrence rate of only 11.9% , a non-relapse mortality rate of 14.0% and a long-term survival of 79.1%. Data from a large retrospective paired study suggested TBF regimen can significantly reduce the relapse rate of acute myeloid leukemia after the first remission (HR=0.4, CI 0.2-0.7, P = .02) without increasing treatment related deaths compared with the traditional BUCY regimen. Based on these data, we modified the TBF regimen with additional cytarabine for allo-HSCT in T-ALL/LBL with expection to reduced disease relapse and improved long-term survival.

NCT ID: NCT05597085 Completed - Clinical trials for Adult Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia

A Study of Patients Who Received Inotuzumab Ozogamicin for B-cell ALL (Acute Lymphoblastic Leukemia) That Occurred Again After the Last Treatment

Start date: March 8, 2023
Phase:
Study type: Observational

The purpose of the study was to understand the effectiveness and safety of the study medicine called Inotuzumab ozogamicin (InO) in patients with B-cell ALL in whom the disease occurred again after the last treatment. This retrospective Study enroll adult patients who: - were CD22 positive (a molecule in the body that stops the over activity of the immune system) - Received only InO for the treatment of B-cell ALL that occurred again after the last treatment - were Philadelphia chromosome positive (which occurs because of changes in genes) - failed treatment with at least one Tyrosine Kinase Inhibitor (type of medicine that blocks the action of enzymes called tyrosine kinases which takes care of many cell functions, such as cell growth and division). The patient data except their personal details are collected from a hospital based electronic medical record in India. In this study the effectiveness and safety of InO will be studied after it was released to the market. To do that, the study aims to gather details of B-cell ALL patients from 7 -10 hospitals across India: - in whom the disease occurred again - or those who never showed any improvement to earlier treatments - now being treated with InO alone Around 55 patients who have taken InO are likely to be enrolled in the study. Then by using a statistical model and with all the information gathered, the safety and effectiveness of InO will be decided.

NCT ID: NCT05596266 Recruiting - Clinical trials for T-cell Acute Lymphoblastic Leukemia

CD5 CAR-T Therapy for Refractory/Relapsed CD5+ T-cell Acute Lymphoblastic Leukemia

Start date: October 25, 2022
Phase: Phase 1
Study type: Interventional

This is a phase I, interventional, single arm, open label, clinical study to evaluate the safety and tolerability of CD5 CAR-T cells in refractory/relapsed CD5+ T-ALL patients who have no available curative treatment options.

NCT ID: NCT05594784 Recruiting - Clinical trials for Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Olverembatinib Combined With Reduced-Intensity Chemotherapy and Venetoclax for de Novo Ph+ ALL

Start date: October 8, 2022
Phase: Phase 2
Study type: Interventional

The introduction of TKIs has greatly improved the prognosis of Ph+ ALL patients. The third-generation TKI ponatinib in combination with chemotherapy has demonstrated superior efficacy to first- and second-generation TKIs. However, unfortunately, ponatinib is not available in mainland China. Olverembatinib is the only third-generation TKI drug currently approved in mainland China. Venetoclax is an oral selective inhibitor of Bcl-2, and small exploratory clinical studies have demonstrated that venetoclax in combination with ponatinib showed high rates of CR as well as molecular response in relapsed/refractory Ph+ ALL. This study will explore the safety and efficacy of olverembatinib in combination with reduced-intensity chemotherapy and venetoclax in patients with newly diagnosed Ph+ ALL.

NCT ID: NCT05592015 Recruiting - Clinical trials for T-Cell Large Granular Lymphocyte Leukemia

Ruxolitinib for the Treatment of T-Cell Large Granular Lymphocytic Leukemia

Start date: May 3, 2023
Phase: Phase 2
Study type: Interventional

This phase II trial tests whether ruxolitinib works to shrink tumors in patients with T-cell large granular lymphocyte leukemia. Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT05590702 Recruiting - CLL/SLL Clinical Trials

French Observational Study of Patients With Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma in Real-World Settings

FOLLOW
Start date: November 11, 2022
Phase:
Study type: Observational [Patient Registry]

Chronic lymphocytic leukemia (CLL) is the most frequent form of leukemia in the Western World. The disease is characterized by the accumulation and proliferation of mature, monoclonal, CD5+ B-cells with specific immunophenotype in the peripheral blood (above 5x109/L), bone marrow and secondary lymphoid organs. Small lymphocytic leukemia (SLL) is characterized by similar tumor cells but without increased lymphocyte count. The management of these patients have considerably changed over the last decade. Indeed, beyond chemo-immunotherapy, multiple targeted therapies have been approved on the basis of phase 2 and randomized phase 3 clinical trials and have subsequently been used in daily practice. The management of patients with SLL is similar to that of those with CLL. In addition to therapeutic advances, the advent of new sequencing technologies has also identified CLL genetic features that are now being incorporated in patient routine evaluation. We here propose to set a large-scale prospective and non-interventional study including patients with symptomatic CLL/SLL with the aim to evaluate the real-world clinical management of these patients and to identify the impact of treatments and therapeutic trajectories on long-term outcome.

NCT ID: NCT05581030 Recruiting - Clinical trials for Acute Lymphoblastic Leukemia

CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

Start date: May 1, 2023
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the safety and tolerability of the study drug, calaspargase pegol, when given with multi-agent chemotherapy.

NCT ID: NCT05579132 Recruiting - Clinical trials for Acute Lymphoblastic Leukemia

A Phase Ib/II Study of CN201 in Precursor B-cell Acute Lymphoblastic Leukemia

Start date: September 30, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

An effective treatment for adults and children B-ALL represents a significant unmet need. CN201 has demonstrated efficacy in nonclinical models of leukemia .CN201 has a longer half-life, thus long term continuous intravenous infusion is not necessary for clinical use. The present study will be conducted in 2 parts: Phase Ib is a dose finding phase to identify the RP2D. Phase II will allow further evaluation of the safety and efficacy of CN201 at the RP2D.

NCT ID: NCT05578378 Recruiting - Clinical trials for Acute Lymphoblastic Leukemia

Cladribine Combined With G-CSF and Cytarabine as a Salvage Treatment in R/R ALL

Start date: January 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

To explore the efficiency and safety of CLAG regimen in R/R ALL

NCT ID: NCT05576181 Not yet recruiting - Clinical trials for Allogeneic, CAR-T, Protein Sequestration, Non-gene Edited

Safety and Efficacy of ThisCART19A Bridging Hematopoietic Stem Cell Transplantation in Patients With Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia

Start date: October 15, 2022
Phase: Phase 1
Study type: Interventional

This is a a phase 1, open label study to assess the safety and efficacy of ThisCART19 (Allogeneic CAR-T targeting CD19) Bridging Hematopoietic Stem Cell Transplantation in patients with refractory or relapsed B cell acute lymphoblastic leukemia (r/r B-ALL).