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Leukemia, Myeloid, Acute clinical trials

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NCT ID: NCT04968015 Recruiting - Clinical trials for Acute Myeloid Leukemia

Venetoclax + Cytarabine Versus Idarubicin + Cytarabine : Efficacity Assessment as Post-remission Therapy to Elderly Patients With Acute Myeloid Leukemia in First Remission

LAMSA2020
Start date: May 25, 2022
Phase: Phase 2
Study type: Interventional

For the FILO group, the standard of care for induction chemotherapy of elderly fit patients with AML is represented by the combination of Cytarabine, Idarubicin and Lomustine. The superiority of this combination was confirmed in a larger prospective study the LAMSA-2007. This induction treatment, followed by six courses of consolidation (Idarubicin and Cytarabine) followed then by a period of 6-month maintenance therapy, allows up to 80 % of remission, and a RFS of 46 % at 2 years. The aim of the study is to assess the efficacy on outcome of Venetoclax combined with Cytarabine versus Idarubicin combined with Cytarabine administered as post-remission therapy to elderly patients with acute myeloid leukemia in first complete remission (CR) following induction chemotherapy.

NCT ID: NCT04964518 Recruiting - AML, Adult Clinical Trials

A Study of APG-2575 in Combination With Azacitidine in Patients With Acute Myeloid Leukemia (AML)

Start date: July 30, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase Ib/II, open-label, multi-center study evaluating the safety, tolerability, efficacy and PK of APG-2575 in combination with Azacitidine in the patients with AML/MPAL or MDS/CMML. The study consists of dose escalation (Part I) and dose expansion phase (Part II)

NCT ID: NCT04964505 Recruiting - Clinical trials for Acute Myeloid Leukemia

Uproleselan, Azacitidine, and Venetoclax for the Treatment of Treatment Naive Acute Myeloid Leukemia

Start date: July 2, 2021
Phase: Phase 1
Study type: Interventional

This phase I trial evaluates the side effects of uproleselan, azacitidine, and venetoclax in treating older or unfit patients with treatment naive acute myeloid leukemia. Uproleselan may help block the formation of growths that may become cancer. Chemotherapy drugs, such as azacitidine, 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. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving uproleselan with azacitidine and venetoclax may help kill more cancer cells.

NCT ID: NCT04951778 Recruiting - Clinical trials for Myelodysplastic Syndromes

Study to Evaluate Safety and Tolerability of CC-91633 (BMS-986397) in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes

Start date: December 2, 2021
Phase: Phase 1
Study type: Interventional

Study CC-91633-AML-001 is a Phase 1, open-label, dose escalation and expansion, first-in-human (FIH) clinical study of CC-91633 (BMS-986397) 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 (Part A) of the study will enroll participants with R/R AML and R/R HR-MDS and will evaluate the safety and tolerability of escalating doses of CC-91633 (BMS-986397), administered orally, and determine the maximum tolerated dose (MTD) or preliminary recommended Phase 2 dose (RP2D) and schedule. Throughout the study, final decisions on dose escalation/de-escalation will be made by the safety review committee (SRC). Approximately 40 participants may be enrolled in Part A of the study. The expansion part (Part B) will confirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development. Separate expansion cohorts for participants with R/R AML and R/R HR-MDS may enroll approximately 20 to 40 response evaluable participants per cohort. Parts A and B will consist of 3 periods: Screening, Treatment, and Follow-up.

NCT ID: NCT04943757 Recruiting - Clinical trials for Myelodysplastic Syndromes

Post-transplantation Benadamustine and Cyclophosphamide in Patients With Refractory Myeloid Malignancies

PTBCy
Start date: January 21, 2021
Phase: Phase 2
Study type: Interventional

Prognosis of patients undergoing salvage allogeneic stem cell transplantation for refractory leukemia or other refractory myeloid malignanies is poor. One of the approaches to augment graft-versus-leukemia effect the use of post-transplantation bendamustine in graft-versus-host disease prophylaxis. Despite high frequency of responses and durable remissions after this approach majority of patients develop a serious complication - cytokine release syndrome, which can be life-threatening in some patients. On the other hand post-transplantation cyclophocphamide was reported to abort cytokine release syndrome that sometimes occurs after graft transfusion in patients after haploidentical graft transfusion. The aim of this study is to evaluate if the combination of post-transplantation bendamustine (PTB) and post-transplantation cyclophosphamide (PTCY) facilitates comparable graft-versus leukemia effect to PTB, but with better safety profile and reduced incidence of severe cytokine release syndrome.

NCT ID: NCT04940468 Recruiting - Lymphoma Clinical Trials

High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology

Start date: October 21, 2022
Phase: N/A
Study type: Interventional

The primary objective of the study is to determine whether dietary intervention to increase fiber and decrease fat reduces C. difficile infection recurrence in a cohort of oncology patients.

NCT ID: NCT04937166 Recruiting - Clinical trials for Acute Myeloid Leukemia

A Study of Dual-SIgnaling Protein 107 (DSP107) for Patients With Hematological Malignancies

Start date: January 13, 2022
Phase: Phase 1
Study type: Interventional

This study will be divided into two parts, Parts A and B and will enroll patients with relapsed/refractory AML or MDS/chronic myelomonocytic leukemia (CMML) patients who have failed up to 2 prior therapeutic regimens. Part A is a dose escalation study to explore the safety, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) profile of DSP107 when administered in combination with azacitidine (AZA). Part B is a dose escalation study to explore the safety, efficacy, PK and PD profile of DSP107 when administered in combination with AZA and venetoclax (VEN).

NCT ID: NCT04914845 Recruiting - Clinical trials for Acute Myeloid Leukemia

KPT-9274 in Patients With Relapsed and Refractory Acute Myeloid Leukemia

Start date: August 27, 2021
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety and tolerability of oral KPT-9274 for the treatment of patients with relapsed or refractory acute myeloid leukemia.

NCT ID: NCT04913922 Recruiting - Clinical trials for Acute Myeloid Leukemia

Relatlimab With Nivolumab and 5-Azacytidine for the Treatment of AML

AARON
Start date: May 5, 2021
Phase: Phase 2
Study type: Interventional

The clinical trial will test the safety and tolerability of a combination therapy (azacitidine in combination with two checkpoint inhibitors, nivolumab [Anti-PD1] and relatlimab [Anti-LAG3]) in patients with relapsed/refractory Acute Myeloid Leukemia (AML) and patients ≥ 65 years with initial diagnosis of AML. Primary objectives are: - maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of the combination therapy during the lead-in phase of the clinical trial (6-12 patients) and - objective response rate (ORR) of the combination therapy in the phase II part of the study (up to 24 patients).

NCT ID: NCT04906031 Recruiting - Clinical trials for Acute Myeloid Leukemia

Sodium Stibogluconate in the MDS/AML With One of the 65 Defined p53 Mutations

Start date: June 1, 2020
Phase: Phase 2
Study type: Interventional

To evaluate the safety and effectiveness of Sodium Stibogluconate in the treatment of myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) with p53 mutation from a defined list. The list includes 65 p53 mutations that were experimentally confirmed to be pharmacologically restored with tumor-suppressive function by antimonials.