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Myelodysplastic Syndromes clinical trials

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NCT ID: NCT04631211 Terminated - Clinical trials for Myelodysplastic Syndromes

Thrombosomes® in Bleeding Thrombocytopenic Patients Study

Start date: March 5, 2021
Phase: Phase 2
Study type: Interventional

This prospective, multicenter, randomized, open-label, Phase 2, parallel, dose ranging, multidose trial will enroll patients into 3 Thrombosomes dose groups and 1 control liquid stored platelets (LSP) group in order to evaluate, in a dose-escalation manner, the safety, and impact on bleeding, and the preliminary effect on coagulation measures of increasing doses of allogeneic Thrombosomes in comparison to standard of care, LSP.

NCT ID: NCT04623996 Terminated - Clinical trials for Anemia in Myelodysplastic Syndromes

A Study of TP-0184 to Treat Anemia in Adults With IPSS-R Low or Intermediate Risk MDS

Start date: December 28, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate preliminary safety and efficacy of TP-0184 to treat anemia when administered to adult patients with Revised International Prognostic Scoring System (IPSS-R) low or intermediate risk MDS. The recommended Phase 2 dose (RP2D) will be determined by the maximum tolerated dose (MTD) or maximum administered dose (MAD) in the Phase 1 portion of the study.

NCT ID: NCT04526288 Terminated - Clinical trials for Acute Myeloid Leukemia

CPX-351 Versus Immediate Stem Cell Transplantation for the Treatment of High-Grade Myeloid Cancers With Measurable Residual Disease

Start date: August 9, 2021
Phase: Phase 2
Study type: Interventional

This phase II trial studies the effect of CPX-351 followed by donor stem cell transplantation versus immediate donor stem cell transplantation in treating patients with high-grade myeloid cancers with measurable residual disease. Chemotherapy drugs, such as CPX-351, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before donor stem cell transplantation may help kill cancer cells in the body and make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow.

NCT ID: NCT04326764 Terminated - Clinical trials for Myelodysplastic Syndromes (MDS)

Panobinostat Maintenance After HSCT fo High-risk AML and MDS

Start date: July 24, 2018
Phase: Phase 3
Study type: Interventional

Aim of this prospective randomized trial is to compare maintenance treatment with panobinostat interspersed with donor lymphocyte infusions (DLI) versus the standard approach of pre-emptive DLI alone in patients with poor-risk AML/MDS having favorably received an allogeneic HSCT followed by engraftment, donor chimerism and hematopoietic reconstitution.

NCT ID: NCT04313881 Terminated - Clinical trials for Myelodysplastic Syndromes

Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)

ENHANCE
Start date: September 9, 2020
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate/high/very high risk myelodysplastic syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R) as measured by complete remission (CR) and overall survival (OS).

NCT ID: NCT04166929 Terminated - Clinical trials for Acute Myeloid Leukemia

Haploidentical Stem Cell Transplant With or Without NK Cell Infusion in AML and MDS

Bigeminy
Start date: January 15, 2020
Phase: Phase 2
Study type: Interventional

Relapse after an allogeneic hematopoietic stem cell transplantation (HSCT) is high in patients with advanced AML, in the 50% range. NK cells have been shown to possess significant anti-leukemic activity and may be used to reduce the incidence of relapse in patients with advanced AML. Investigators hypothesize that the administration of a purified boost of NK cells on day +7 post HSCT, will reduce the incidence of relapse from the current 50% to 25%. In a phase III multicenter clinical study, 116 patients will be randomized to receive or not a boost of donor NK cells on day +7 post-HSCT. The first 10 patients in the experimental arm will be analyzed for toxicity. The stopping rule will be a transplant related mortality of more than 50% in the first 20 patients who received NK cells.

NCT ID: NCT04095858 Terminated - Clinical trials for Acute Myeloid Leukemia

Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft Versus Host Disease (GVHD) Following Myeloablative Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-005)

CATHY
Start date: January 5, 2021
Phase: Phase 3
Study type: Interventional

The study compares two acute graft-versus-host disease (aGVHD) prophylaxis regimens: efprezimod alfa vs placebo with the standard GVHD prophylaxis of tacrolimus / methotrexate. The study compares two acute graft-versus-host disease (aGVHD) prophylaxis regimens: efprezimod alfa/tacrolimus / methotrexate (efprezimod alfa/Tac/MTX) versus placebo/tacrolimus / methotrexate (placebo/Tac/MTX) in the setting of myeloablative conditioning (MAC), matched unrelated donor (MUD) allogeneic hematopoietic stem cell transplantation in participants with acute leukemia (AML/ALL) or myelodysplastic syndrome (MDS). The study agent, efprezimod alfa, will be administered through IV infusion on days -1, 14, and 28 at the dose of 480mg, 240 mg and 240mg, respectively. The placebo will be 100 ml normal saline intravenous (IV) solution.

NCT ID: NCT03920657 Terminated - Clinical trials for Myelodysplastic Syndromes

Early and Low Dose Deferasirox (3.5 mg/kg FCT) to Suppress NTBI and LPI as Early Intervention to Prevent Tissue Iron Overload in Lower Risk MDS

Start date: October 4, 2019
Phase: Phase 2
Study type: Interventional

The scientific rationale for this study is the evolving understanding that iron-induced tissue damage is not only a process of progressive bulking of organs through high-volumes iron deposition, but also a reactive iron species related "toxic" damage. Iron mediated damage can occur prior reaching high iron storage thresholds derived from thalassemia major setting, free toxic iron species being already present when transferrin saturation >60-70% (25); therefore a timely early adoption of iron chelation may be of benefit before overt iron overload is seen. Our hypothesis is that early and low dose DFX-FCT is better tolerated and is able to prevent iron accumulation and consequently tissue iron related damage, by consistently suppressing iron reactive oxygen species (NTBI and LPI). If this hypothesis is confirmed this approach could contribute to an improvement of clinical practice of patients managements. Additionally this approach might also be a contribute in preventing future iron overloaded related complication, in this already frail and co-treated patient population.

NCT ID: NCT03878524 Terminated - Anemia Clinical Trials

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Start date: April 1, 2020
Phase: Phase 1
Study type: Interventional

This phase Ib trial determines if samples from a patient's cancer can be tested to find combinations of drugs that provide clinical benefit for the kind of cancer the patient has. This study is also being done to understand why cancer drugs can stop working and how different cancers in different people respond to different types of therapy.

NCT ID: NCT03735446 Terminated - Clinical trials for Acute Myeloid Leukemia

Prexasertib in Combination With MEC in Relapsed/Refractory AML and High Risk MDS - a Phase I Trial

Start date: January 18, 2019
Phase: Phase 1
Study type: Interventional

This research study is studying a targeted therapy combined with chemotherapy as a possible treatment for acute myeloid leukemia (AML) or high risk myelodysplastic syndrome (MDS). The drugs involved in this study are: - Prexasertib (LY2606368) - Mitoxantrone - Etoposide - Cytarabine