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Preleukemia clinical trials

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NCT ID: NCT04701229 Recruiting - Clinical trials for Myelodysplastic Syndromes

Haploinsufficiency of the RBM22 and SLU7 Genes in Del(5q) Myelodysplastic Syndromes

SMD-RMB22
Start date: September 30, 2020
Phase:
Study type: Observational

Myelodysplastic syndromes (MDS) are malignant hematopathies of the elderly characterized by persistent cytopenias and the presence of deregulated clonal hematopoiesis. The risk of progression to acute myeloid leukemia (AML) is variable. Acquired cytogenetic abnormalities are found in less than 50% of de novo cases and up to 80% in secondary MDS. The deletion of the long arm of chromosome 5 (written del(5q)) is the most common abnormality in MDS (15%). Del(5q) MDS has a good prognosis, with a median survival of 6 years and a 15% risk of progression to AML. However, their life expectancy is shorter than the general population, and the quality of life of patients is diminished. These treatments are not that effective over a long period of time or not well tolerated, and the majority of patients die from causes related to their MDS, such as infections (38%), progression to AML (15%), or bleeding (13%). Two genes, RBM22 and SLU7, coding for proteins of the same complex involved in splicing pre-messenger RNA are carried on the long arm of chromosome 5. We investigate the pronostic impact and the predictive value of the double haploinsufficiency of the RBM22 and SLU7 genes in del(5q) myelodysplastic syndromes isolated or not compared to the single haploinsufficiency of RBM22 and normal karyotype myelodysplastic syndromes.

NCT ID: NCT04691141 Terminated - Clinical trials for Myelodysplastic Syndrome

A Study to Evaluating the Pharmacokinetics, Safety, and Efficacy of ATG 016 Monotherapy in IPSS-R Intermediate Risk and Above Myelodysplastic Syndrome (MDS)

HATCH
Start date: February 23, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase Ⅰ/II, Open-label Study to Investigate the Pharmacokinetics, Safety, and Efficacyof ATG 016 Monotherapy in IPSS-R Intermediate Risk and above Myelodysplastic Syndrome (MDS) Patients after Failure of Hypomethylating Agent (HMA)-based Therapy.

NCT ID: NCT04678401 Recruiting - Clinical trials for Myelodysplastic Syndromes

IS-free Treg HaploHCT

Start date: January 12, 2021
Phase: Phase 1
Study type: Interventional

This research study is evaluating the safety and efficacy of the IS-free Treg-cell graft-engineered haplo transplant method in people with relapsed/refractory and Ultra-high risk acute myeloid leukemia (AML) and/or myelodysplastic syndromes (MDS) receiving a haploidentical donor allogeneic hematopoietic stem cell transplant (HSCT). The names of the study interventions involved in this study are: - Radiation-Total Myeloid and Lymphoid Irradiation (TMLI - Chemotherapy (Fludarabine, Thiotepa, Cyclophosphamide plus Mesna) - Infusion of haplo Treg-enriched donor cells (experimental therapy) - Infusion of unmodified haplo donor T cells (includes cancer-fighting T effector cells) - Infusion of haplo donor CD34+ Peripheral Blood Stem Cells

NCT ID: NCT04668885 Active, not recruiting - Clinical trials for Myelodysplastic Syndromes

CPX-351 as a Novel Approach for the Treatment of Older Patients With AML and MDS

Start date: January 14, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate how effective lower doses of CPX-351 are in older participants with relapsed/refractory acute myeloid leukemia (AML) who are not eligible to receive intensive chemotherapy and in participants with myelodysplastic syndromes (MDS) after Hypomethylating Agents (HMA) failure.

NCT ID: NCT04655755 Recruiting - Clinical trials for Myelodysplastic Syndrome

Venetoclax in Combination With ASTX727 for the Treatment of Treatment-Naive High-Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

Start date: January 19, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies the side effects and best dose of venetoclax in combination with cedazuridine and decitabine (ASTX727) in treating patients with high risk myelodysplastic syndrome or chronic myelomonocytic leukemia who have not received prior treatment (treatment-naive). Chemotherapy drugs, such as venetoclax, cedazuridine, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

NCT ID: NCT04639024 Terminated - Clinical trials for Acute Myeloid Leukemia (AML)

ADCT-301 in Patients With R/R AML, MDS, or MDS/MPN

Start date: December 7, 2021
Phase: Phase 2
Study type: Interventional

This is research study to find out if a drug called ADCT-301 is safe and to look at how patients respond to the study drug after an allogeneic transplantation. ADCT-301 will be administered on Days 1, 8 and 15 with blood tests following study drug infusion. Patients will have a bone marrow biopsy at the end of cycle 2/before cycle 3 to see how they are responding to the study drug. Patients will be followed for approximately every 12 weeks from the last disease assessment for up to 1 year from completion of therapy. There are risks to this study drug. Some risks include: decrease in certain blood cells, weight loss, loss of appetite, rash and Guillain-Barre syndrome, where the immune system attacks and damages nerves.

NCT ID: NCT04638309 Terminated - Clinical trials for Myelodysplastic Syndromes

APR-548 in Combination With Azacitidine for the Treatment of TP53 Myelodysplastic Syndromes (MDS)

Start date: September 20, 2021
Phase: Phase 1
Study type: Interventional

Phase 1 study evaluating the safety and efficacy of APR-548 in combination with Azacitidine for the treatment of TP53-Mutant Myelodysplastic Syndromes.

NCT ID: NCT04628338 Completed - Clinical trials for Myelodysplastic Syndromes

IFN-γ to Treat Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) That Has Relapsed After Allogeneic Hematopoietic Stem Cell Transplantation

Start date: March 8, 2021
Phase: Early Phase 1
Study type: Interventional

This study proposes a safe dosing regimen IFN-γ that is sufficient to stimulate IFN-γ receptors on malignant blasts in patients who developed relapsed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after alloSCT with no active or history of III-IV acute graft-versus-host disease (GVHD). It is hypothesized that IFN-γ will promote graft-vs-leukemia (GVL) in patients with AML/MDS that has relapsed after alloSCT.

NCT ID: NCT04628026 Recruiting - Clinical trials for Acute Myeloid Leukemia

Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2

Start date: September 13, 2022
Phase: Phase 3
Study type: Interventional

A Randomized, Placebo-Controlled Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome With Excess Blasts-2

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.