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Preleukemia clinical trials

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NCT ID: NCT05782127 Recruiting - Clinical trials for Untreated Myelodysplastic Syndrome

Oral Azacitidine Combined With Venetoclax in Previously Untreated Higher-risk Myelodysplastic Syndromes

Start date: December 6, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II open-label, dose-finding, multi-center study will assess safety and primary efficacy of Onureg and Venetoclax combination, to define the optimal biological dose and optimal treatment duration of Onureg to be used along with Venetoclax for further studies in previously untreated patients with higher-risk myelodysplastic syndromes (HR-MDS) not eligible to transplant.

NCT ID: NCT05766514 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia

Trial of Cladribine and Low-Dose Cytarabine (LoDAC) Alternating With Decitabine vs. Hypomethylating Agents (HMA) Plus Venetoclax as Frontline Therapy for AML or High-Grade MDS in Patients Unfit for Intensive Induction

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

This phase II, open-label, randomized trial will compare the efficacy of the novel regimen of cladribine/low-dose cytarabine alternating with decitabine to the current standard of care regimen of hypomethylating agents (decitabine or azacytidine) plus venetoclax in elderly and unfit patients presenting with AML or high grade MDS for whom targeted therapy based on the molecular/genetic subtype is not available. Subjects will be randomized to be treated with either cladribine/low-dose cytarabine alternating with decitabine (Arm A) or decitabine or azacitadine plus venetoclax (Arm B).

NCT ID: NCT05732961 Recruiting - Anemia Clinical Trials

Luspatercept for Anemia in Lower Risk MDS or Non-proliferative MDS/MPN Neoplasms

Start date: February 21, 2023
Phase: Phase 2
Study type: Interventional

The purpose of the study is to see if participants with anemia due to their type of MDS or MDS/MPN will experience a more decreased need for regular blood transfusions if they take luspatercept plus best supportive care, and what effect, good and/or bad, luspatercept has on them and their anemia due to MDS or MDS/MPN. The safety and tolerability of luspatercept will also be evaluated in this study.

NCT ID: NCT05732103 Recruiting - Clinical trials for Acute Myeloid Leukemia

A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes

Start date: April 25, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this phase 1/2 multicenter, open-label, singe arm dose escalation and expansion study is to assess the safety, tolerability, pharmacokinetic and pharmacodynamic profile of CTX-712 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and higher risk myelodysplastic syndromes (HR-MDS). The phase 1 part of the study consists of sequential standard 3 + 3 dose escalation, where patients will receive ascending doses of CTX-712 to determine the recommended phase 2 dose (RP2D) for further clinical development. This is followed by a confirmatory phase 1 expansion cohort where an additional approximately 10 patients will be treated with CTX-712 at the RP2D to gain further confidence in the selected dose level. After RP2D is determined, Drug-Drug-Interaction cohorts will be started. The phase 2 part of the study will commence after the RP2D has been identified and confirmed and will evaluate therapeutic activity in R/R AML or R/R HR-MDS, in addition to confirmation of the safety profile.

NCT ID: NCT05709093 Recruiting - Clinical trials for Myelodysplastic Syndromes(MDS)

A Phase 3 Clinical Study to Evaluate Lemzoparlimab for Injection in Combination With Azacitidine (AZA) Versus AZA Monotherapy in Treatment-naïve Patients With Higher-risk Myelodysplastic Syndrome (MDS)

Start date: March 30, 2023
Phase: Phase 3
Study type: Interventional

This phase3 study is a randomized, controlled, open-label, multicenter study to evaluate the efficacy and safety of Lemzoparlimab for injection in combination with AZA versus AZA monotherapy as first-line therapy in treatment-naïve subjects with intermediate- and high-risk MDS.

NCT ID: NCT05703542 Recruiting - Clinical trials for Acute Myeloid Leukemia

BXCL701 Phase 1 R/R Acute Myeloid Leukemia or Myelodysplastic Syndrome

Start date: February 2, 2023
Phase: Phase 1
Study type: Interventional

The goal of this research study is to find the safest and most effective dose of the study drug, BXCL701, for the treatment of Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS). The names of the study drugs involved in this study are/is: - BXCL701

NCT ID: NCT05703204 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia and Myelodysplastic Syndrome

A Study of QLF32101 in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

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

This study aimed to evaluate the safety,tolerability and preliminary efficacy of QLF32101 administered intravenously and subcutaneously in patients with R/R, AML.

NCT ID: NCT05687513 Not yet recruiting - MDS Clinical Trials

Clinical Efficacy and Mechanism of Yisui Granule in Treatment of Low and Medium Risk Myelodysplastic Syndrome Through Demethylation

Start date: January 2023
Phase: Early Phase 1
Study type: Interventional

The goal of this clinical trial is to explore the mechanism of Yisui Granule(YSG) in the treatment of myelodysplastic syndrome(MDS) through demethylation. Under the same condition of basic western medicine treatment, the treatment group used the same traditional Chinese medicine decoction pieces as YSG, and the control group was given placebo. Through a randomized controlled clinical study, we focused on observing the effects of MDS patients on clinical symptoms (including single symptom), fatigue relief, quality of life, peripheral blood picture, blood transfusion interval and blood transfusion volume, and measured the expression of DNMTs, the expression and methylation level of Wnt3a、β-catenin、SFRP and other indicators, as well as cytokines, were used to explore the mechanism of YSG in the treatment of MDS through demethylation.

NCT ID: NCT05674539 Recruiting - Clinical trials for Allogeneic Hematopoietic Stem Cell Transplantation

Reduced Intensity Conditioning Regimens for Acute Myeloid Leukemia and Myelodysplastic Syndrome

Start date: December 28, 2022
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to compare outcomes of two reduced intensity conditioning (RIC) regimens (fludarabine plus busulfan and fludarabine plus melphalan) in allogeneic hematopoietic stem cell transplantation (HSCT) for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients. The main questions it aims to answer are: - The safety of two reduced intensity conditioning (RIC) regimens (fludarabine plus busulfan and fludarabine plus melphalan) in allogeneic hematopoietic stem cell transplantation for adult AML/MDS patients with HCT-CI≥3 or aged ≥55 years. - The efficacy of two reduced intensity conditioning (RIC) regimens (fludarabine plus busulfan and fludarabine plus melphalan) in allogeneic hematopoietic stem cell transplantation for adult AML/MDS patients with HCT-CI≥3 or aged ≥55 years. Participants will be randomized to one of two reduced intensity conditioning (RIC) regimens (fludarabine plus busulfan and fludarabine plus melphalan)

NCT ID: NCT05673057 Recruiting - Leukemia Clinical Trials

Study of MP0533 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Start date: December 29, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and preliminary activity of MP0533 in patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)