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Myelodysplastic Syndromes clinical trials

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NCT ID: NCT06247917 Recruiting - Clinical trials for Myelodysplastic Syndromes

Evaluate the Efficacy and Safety of Allogeneic Haematopoietic Stem Cell Transplantation With FBM Conditioning for MDS

Start date: March 3, 2024
Phase: Phase 2
Study type: Interventional

To assess the safety and efficacy of FLU-BU-MEL as a conditioning regimen for allogeneic hematopoietic stem cell transplantation in patients with untreated MDS-EB or IPSS-R that is intermediate-risk (>3.5 points), high-risk, or very high-risk. The investigators conducted this clinical trial.There will be three phases to this trial: screening, therapy, and follow-up. A) Screening phase: Qualified patients are screened for trial participation by a medical history, physical examination, laboratory testing, and disease evaluation after providing their informed consent. B) Treatment duration: patients receive allogeneic hematopoietic stem cell transplantation prepped with Flu-Bu-Mel in accordance with the protocol. C) Follow-up period: patients were checked on at the scheduled time to assess safety and efficacy. HSCT conditioning regiment: Flu 30 mg/m2/d d-6 days to d-2 9 (intravenously over two hours), : MEL 50 mg/m2/d intravenously, d-3 to d-2; BU 0.8 mg/kg/q6h d-6 to d-5 (intravenously, over 2 hours per drip). Fludarabine and melphalan do not require a dose adjustment based on body weight; however, if body mass index BMI> 25, ideal body weight (IBW) should be calculated (as BMI=25), and then determine Busulfan dosage based on corrected body weight (AIBW25). AIBW25=IBW+25% x (actual body weight - IBW)

NCT ID: NCT06218771 Recruiting - Clinical trials for Acute Myeloid Leukemia

A Study of TQB3454 Tablets in Patients With Blood Tumors

Start date: July 10, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this clinical trial is to evaluate the safety of TQB3454 tablets in patients with acute myeloid leukemia and myelodysplastic syndrome, and determine the phase II recommended dose.

NCT ID: NCT06206174 Recruiting - Clinical trials for Acute Myeloid Leukemia

TGRX-814 Chinese Phase I/II in Patients With Hematological Malignancies

Start date: March 6, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this single- arm, open-label, dose escalation and dose expansion phase I/II study is to evaluate the safety, tolerability, pharmacokinetic and preliminary efficacy of TGRX-814 in patients with hematological malignancies including non-Hodgkin lymphoma, acute myeloid leukemia, aute lymphoblastic leukemia and myelodysplastic syndromes.

NCT ID: NCT06196203 Recruiting - Clinical trials for Higher-risk Myelodysplastic Syndromes

A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes

Start date: February 7, 2024
Phase: Phase 2
Study type: Interventional

This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of AK117 or placebo, combined with azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS).

NCT ID: NCT06195891 Recruiting - Clinical trials for Acute Myeloid Leukemia

Orca-T Following Chemotherapy and Total Marrow and Lymphoid Irradiation for the Treatment of Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia or Myelodysplastic Syndrome

Start date: September 28, 2024
Phase: Phase 1
Study type: Interventional

This phase I trial tests the side effects and best dose of total marrow lymphoid irradiation along with chemotherapy, with fludarabine and melphalan, with or without thiotepa, in combination with Orca-T cells for patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) or myelodysplastic syndrome (MDS). Total marrow and lymphoid irradiation is a targeted form of total body irradiation that uses intensity-modulated radiation therapy to target marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize the radiation therapeutic effect. Giving chemotherapy with medications such as thiotepa, fludarabine, and melphalan before a treatment with stem cells helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Orca-T cells take cells from a donor and remove some of the T cells and replace them with partially engineered T cells in order to induce better tolerance in patients. Giving total marrow and lymphoid irradiation and chemotherapy followed by Orca -T cells may be an effective treatment for patients with AML, ALL or MDS.

NCT ID: NCT06146257 Recruiting - Clinical trials for Acute Myeloid Leukemia

A Study of GLB-001 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher Risk Myelodysplastic Syndromes

Start date: January 11, 2024
Phase: Phase 1
Study type: Interventional

Study GLB-001-01 is a first-in-human (FIH), Phase 1, open-label, dose escalation and expansion clinical study of GLB-001 in participants with relapsed or refractory acute myeloid leukemia (R/R AML) or in participants with relapsed or refractory higher-risk myelodysplastic syndromes (R/R HR-MDS). The dose escalation part (Phase 1a) of the study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of GLB-001 administered orally. Approximately 24 participants (up to 42 participants) may be enrolled in Phase 1a of the study. The dose expansion part (Phase 1b) will be followed to understand the relationships among dose, exposure, toxicity, tolerability and clinical activity, to identify minimally active dose, and to select the recommended dose(s) for phase 2 study. Up to 24 participants (12 participants per dose level) may be enrolled in Phase 1b of the study.

NCT ID: NCT06144515 Recruiting - Clinical trials for Myelodysplastic Syndromes

Collection of Samples of Bone Marrow Aspiration From Patients With Myelodysplastic Syndrome

Start date: February 9, 2023
Phase:
Study type: Observational

The study Objective is to collect samples of bone marrow aspirates and peripheral blood of patients with MDS for use in non-clinical research to investigate mitochondrial function sequence and effect of mitochondrial augmentation.

NCT ID: NCT06143839 Recruiting - Clinical trials for Acute Myeloid Leukemia (AML)

VYxeoS Liposomal Italian Observational Study iN the Real Practice

VYSION
Start date: December 7, 2023
Phase:
Study type: Observational

The study is a prospective, single-arm, non-experimental, observational study in patients in Italy with Acute Myeloid Leukaemia (AML) with myelodysplastic-related changes or therapy related AML initiating treatment with JZP351 (Vyxeos liposomal) in their normal clinical practice.

NCT ID: NCT06138587 Recruiting - Leukemia Clinical Trials

Preemptive CIML NK Cell Therapy After Hematopoietic Stem Cell Transplantation

Start date: January 24, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this research study is to test the safety and efficacy of cytokine induced memory-like (CIML) natural killer (NK) cells expanded with Interleukin-2 (IL-2) at preventing relapse in acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or MDS and myeloproliferative neoplasm (MPN) overlap syndrome after a standard-of-care stem cell transplant. Names of the study therapies involved in this study are: - CIML NK cells intravenous infusion (cellular therapy) - Subcutaneous Interleukin-2 (recombinant, human glycoprotein)

NCT ID: NCT06130579 Recruiting - Clinical trials for Myelodysplastic Syndromes

Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT

Start date: January 1, 2024
Phase: Phase 2
Study type: Interventional

To investigate the efficacy of interferon-α prophylaxis in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) with TP53 mutation who were negative for minimal residual disease (MRD) by flow cytometry within 2 months after allogeneic hematopoietic stem cell transplantation. To explore the efficacy of interferon-α in reducing the relapse rate of AML/MDS patients with TP53 mutation after allogeneic hematopoietic stem cell transplantation (allo-HSCT).