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Preleukemia clinical trials

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NCT ID: NCT05829226 Recruiting - MDS Clinical Trials

A Phase 1 Study With LYT-200 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML), or With Relapsed/Refractory, High-risk Myelodysplastic Syndrome (MDS)

Start date: December 12, 2022
Phase: Phase 1
Study type: Interventional

A Phase 1 Open-label, Multi-center Study of the Safety, Pharmacokinetics (PK), and Anti-tumor Activity of LYT- 200 in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML), or with Relapsed/refractory, High-risk Myelodysplastic Syndrome (MDS)

NCT ID: NCT05823714 Recruiting - Clinical trials for Acute Myeloid Leukemia

Venetoclax+Azacytidine+Modified BUCY Conditioning Regimen for Acute Myeloid Leukemia and Myelodysplastic Syndromes Undergoing Allo-HSCT

Start date: January 20, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this prospective, open-label, single-center study is to evaluate the efficacy and safety of VEN-AZA (venetoclax and azacytidine) followed by modified BUCY (busulfan and cyclophosphamide) as conditioning regimen for high-risk myelodysplastic syndrome (MDS) and high-risk or relapsed/refractory acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).

NCT ID: NCT05805605 Recruiting - Clinical trials for Myelodysplastic Syndromes

Allo HSCT Using RIC and PTCy for Hematological Diseases

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

This is a Phase II study following subjects proceeding with our Institutional non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion using post-transplant cyclophosphamide (PTCy), sirolimus and MMF GVHD prophylaxis.

NCT ID: NCT05796570 Recruiting - Clinical trials for Acute Myeloid Leukemia

A Pilot Study to Evaluate the Feasibility of Post-Hematopoietic Stem Cell Transplant Prophylaxis With Decitabine Combined With Filgrastim for Children and Young Adults With AML, MDS and Related Myeloid Malignancies

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Start date: April 19, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to examine if it is feasible to administer decitabine and filgrastim after allogenic hematopoietic stem cell transplant (HCT) in children and young adults with myelodysplastic syndrome, acute myeloid leukemia and related myeloid disorders, and if the treatment is effective in preventing relapse after HCT. The names of the study drugs involved in this study are: - Decitabine (a nucleoside metabolic inhibitor) - Filgrastim (a recombinant granulocyte colony-stimulating factor (G-CSF)

NCT ID: NCT05788679 Recruiting - Clinical trials for Myelodysplastic Syndromes

A Study Using Subject-specific MRD to Adopt Treatment After HSCT for Subjects With MDS

Start date: November 22, 2022
Phase: Phase 2
Study type: Interventional

The goal of this interventional study is to evaluate if pre-emptive intervention using Azacitidine and / or donor lymphocytes or tapering of immune suppression in measurable residual disease (MRD) positive subjects can prevent clinical relapse. Participants will undergo MRD surveillance and be subjected to intervention in case of MRD positivity. Results will be compared with NMDSG14B, part one, in which MRD was analyzed in included patients without recieving intervention.

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: 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