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Preleukemia clinical trials

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NCT ID: NCT05292664 Recruiting - Clinical trials for Acute Lymphoblastic Leukemia, in Relapse

Venetoclax Basket Trial for High Risk Hematologic Malignancies

Start date: March 29, 2023
Phase: Phase 1
Study type: Interventional

This trial is evaluating the safety and tolerability of venetoclax with chemotherapy in pediatric and young adult patients with hematologic malignancies, including myelodysplastic syndrome (MDS), acute myeloid leukemia derived from myelodysplastic syndrome (MDS/AML), and acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LBL). The names of the study drugs involved in this study are below. Please note this is a list for the study as a whole, participants will receive drugs according to disease cohort. - Venetoclax - Azacitidine - Cytarabine - Methotrexate - Hydrocortisone - Leucovorin - Dexamethasone - Vincristine - Doxorubicin - Dexrazoxane - Calaspargase pegol - Hydrocortisone

NCT ID: NCT05275439 Recruiting - Clinical trials for Acute Myeloid Leukemia

Phase 1 Study of Shattuck Labs (SL)-172154 in Subjects With MDS or AML

Start date: March 17, 2022
Phase: Phase 1
Study type: Interventional

SL03-Old Hundred(OHD)-104 is designed as a Phase 1a/1b open label, trial to evaluate the safety, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of SL-172154 monotherapy as well as in combination with azacitidine or in combination with Azacitidine and Venetoclax.

NCT ID: NCT05263271 Recruiting - Clinical trials for Myelodysplastic Syndromes

Gentulizumab in Relapsed/Refractory Acute Myelogenous Leukemia or Myelodysplastic Syndrome

Start date: April 1, 2021
Phase: Phase 1
Study type: Interventional

Gentulizumab Injection is an anti-CD47 monoclonal antibody. As a member of the immunoglobulin superfamily, CD47 is expressed at low levels on many cells of the body, including hematopoietic cells (red blood cells, lymphocytes, platelets, etc.) and non-hematopoietic cells (placenta, liver and brain cells). It is overexpressed on many types of tumors. There is abundant supportive evidence that the expression of CD47 on tumor cells, though binding to SIRP on professional phagocytes, acts to prevent tumor cell phagocytosis, inhibit antigen cross-presentation, and block the production of pro-inflammatory molecules, thus promoting the development of a "cold" tumor microenvironment. Blocking CD47 can not only stimulate phagocytosis to cancer cells, but also promote macrophage recruitment towards neoplasm. At the same time, blocking CD47 can stimulate macrophages to secrete cytokines. These cytokines and chemokines can further recruit other immune cells to neoplasms. These newly recruited immune cells can provide a positive feedback and enhance the therapeutic response of blocking CD47. Therefore, the CD47/SIRPα axis blocking appears to be a potential therapeutic target for neoplasm. Currently, no anti-CD47 antibody product has been granted marketing authorization for progressive hematological malignancies. Whereas Hu5F9-G4, a CD47 monoclonal antibody, is being tested in a series of ongoing clinical trials for AML, MDS, lymphomas and multiple solid tumors. The clinical research was designed based on non-clinical data and relevant experience of other CD47 monoclonal antibody. In this phase Ia study, "3 + 3" dose escalation method combined with rapid titration will be used to evaluate the dose limiting (DLT) toxicity of each dose group, evaluate the safety and tolerance of Gentulizumab in the treatment of patients with progressive hematological malignancies, and determine the maximum tolerated dose (MTD) and phase II recommended dose (RP2D); At the same time, the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, preliminary efficacy and biomarkers of gentulizumab will be evaluated to provide sufficient basis for new drug application (NDA) guidance and further clinical use.

NCT ID: NCT05246384 Withdrawn - Clinical trials for Acute Myeloid Leukemia

Study to Evaluate the Safety, Pharmacokinetics and Clinical Activity of RP7214 in Combination With Azacitidine in Patients With Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Acute Myeloid Leukemia

Start date: January 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-center, open-label, non-randomized, two-part Phase I/Ib study of RP7214 in combination with azacitidine in patients with AML, MDS and CMML. Part I is a 3+3 dose-escalation study to identify the MTD/RP2D of RP7214 and azacitidine combination in patients with AML, MDS, and CMML. Part II is a dose-expansion study to evaluate the clinical activity and safety of RP7214 and azacitidine combination in AML.

NCT ID: NCT05237713 Terminated - Anemia Clinical Trials

Efficacy and Safety of Canakinumab for the Treatment of Anemia in LR-MDS Patients

Start date: April 26, 2022
Phase: Phase 2
Study type: Interventional

Hematologic improvement of erythrocytes after 6 months of canakinumab treatment.

NCT ID: NCT05236764 Recruiting - Clinical trials for Myelodysplastic Syndromes

Haploidentical Hematopoietic Cell Transplantation Using TCR Alpha/Beta and CD19 Depletion

HAPLOTAB
Start date: December 6, 2023
Phase: N/A
Study type: Interventional

Patients with medical conditions requiring allogeneic hematopoietic cell transplantation (allo-HCT) are at risk of developing a condition called graft versus host disease (GvHD) which carries a high morbidity and mortality. This is a phase I/II study that will test the safety and efficacy of hematopoietic cell transplantation (HCT) with ex-vivo T cell receptor Alpha/Beta+ and CD19 depletion to treat patients' underlying condition. This process is expected to substantially decrease the risk of GvHD thus allowing for the elimination of immunosuppressive therapy post-transplant. The study will use blood stem/progenitor cells collected from the peripheral blood of parent or other half-matched (haploidentical) family member donor. The procedure will be performed using CliniMACS® TCRα/β-Biotin System which is considered investigational.

NCT ID: NCT05223699 Terminated - Clinical trials for Acute Myeloid Leukemia

Study of MGTA-117 in Patients With Adult Acute Myeloid Leukemia (AML) and Myelodysplasia-Excess Blasts (MDS-EB)

Start date: February 14, 2022
Phase: Phase 1
Study type: Interventional

This research study is designed to selectively deplete CD117-positive cells from participants with AML and MDS-EB.

NCT ID: NCT05218902 Completed - Clinical trials for Myelodysplastic Syndromes

A Study of Azacitidine in Participants With International Prognostic Scoring System (IPSS) Intermediate-2 and High-risk Myelodysplastic Syndromes (MDS), or Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)

DIM Vidaza
Start date: February 25, 2022
Phase:
Study type: Observational

The purpose of this study is to assess the safety and effectiveness in the real-world setting among participants who are treated with Azacitidine in accordance with the China Product Label.

NCT ID: NCT05209152 Completed - Clinical trials for Chronic Myelomonocytic Leukemia

AMG 176 With Azacitidine in Subjects With Myelodysplastic Syndrome /Chronic Myelomonocytic Leukemia

Start date: November 14, 2022
Phase: Phase 1
Study type: Interventional

The main objective is to assess the safety, tolerability, and efficacy of AMG 176 as monotherapy and in combination with the 7-day regimen of azacitidine for the treatment of Higher-Risk Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia (HR-MDS/CMML).

NCT ID: NCT05204953 Completed - Clinical trials for Myelodysplastic Syndromes

Mean Platelet Volume and Its Relation to Risk Stratification of Myelodysplastic Syndromes

Start date: October 2013
Phase:
Study type: Observational

The myelodysplastic syndromes (MDS) are a group of myeloid neoplasms characterized by abnormal differentiation and maturation of myeloid cells, reduced bone marrow (BM) function, and a genetic instability with enhanced risk to transform to secondary acute myeloid leukemia, AML