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MDS clinical trials

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NCT ID: NCT05184842 Recruiting - AML Clinical Trials

Metabolically Optimized, Non-cytotoxic Low Dose Weekly Decitabine/Venetoclax in MDS and AML

Start date: March 23, 2022
Phase: Phase 2
Study type: Interventional

Myeloid malignancies which include AML (acute myeloid leukemia) and MDS (myelodysplatic syndrome) are cancers of the bone marrow which lead to bone marrow failure. The bone marrow is the place or factory in the body where components of blood such as red cells, platelets and white cells are made. In bone marrow failure, the ability of the bone marrow to make these cells is decreased. The decreased bone marrow function is the result from abnormalities that develop in the malignant cells which prevent the normal maturation process by which bone marrow cells develop into red blood cells, white blood cells and platelets. The malignant cells in the bone marrow are not good at maturing to make the components of the blood that you need, they occupy space in the bone marrow and prevent the function of remaining normal bone marrow cells. DNA is a chemical substance within cells that stores information needed for cell growth and cell behavior. One approach to treating the malignant cells is to give chemotherapy which damages DNA within these cells and causes their death. Unfortunately, such therapy has side-effects, since even normal cells can be affected by the treatment. Decitabine is FDA approved for treatment of MDS and AML. Venetoclax is approved for AML in combination with Azacitidine for patients with AML or are over age 75 or unfit for chemotherapy. In this study, Decitabine and venetoclax will be administered using a low dose weekly schedule in an attempt to improve efficacy by decreasing the side effects often seen when these drugs are given at standard dosing.

NCT ID: NCT05181735 Recruiting - Clinical trials for Myelodysplastic Syndromes

Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA

Start date: May 18, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Study of the combination of luspatercept in low-risk myelodysplastic syndrom (LR-MDS) without ring sideroblasts (RS) having failed or being ineligible to ESA

NCT ID: NCT05177211 Recruiting - Clinical trials for Myeloproliferative Neoplasm

Fedratinib in Myelodysplastic /Myeloproliferative Neoplasms (MDS/MPNs) and Chronic Neutrophilic Leukemia (CNL)

Start date: March 1, 2022
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the effectiveness, safety, and tolerability of a study drug called fedratinib in participants with myelodysplastic/myeloproliferative neoplasms (MDS/MPNs) and chronic neutrophilic leukemia (CNL).

NCT ID: NCT05175508 Recruiting - AML Clinical Trials

Aza With or Without ATRA in Newly Diagnosed Unfit AML or Intermediate,High or Very High Risk MDS

Start date: May 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This is a randomized, open-label, multicenter study to compare the efficacy and safety of AZA with or without ATRA in newly diagnosed unfit AML or Intermediate,High or Very High Risk MDS

NCT ID: NCT05153226 Recruiting - AML Clinical Trials

GvHD Prophylaxis in Unrelated Donor HCT: Randomized Trial Comparing PTCY Versus ATG

GRAPPA
Start date: March 2, 2022
Phase: Phase 3
Study type: Interventional

Post-transplantation cyclophosphamide (PTCY) has become increasingly popular in the haploidentical HCT setting because it overcomes the HLA-mismatch barrier and levels GVHD risk. This advantage may also prove useful in the context of unrelated donor (UD) transplantation. GVHD prophylaxis for matched unrelated donor hematopoietic cell transplantation (alloHCT) in Europe is mainly conducted with ATG. Still, the burden of acute and chronic GVHD and especially of relapse remains high with both approaches for GVHD prevention. PTCY has not been tested against the current standard ATG for GvHD prophylaxis in large randomized trials. The goal of this trial is to compare the outcomes of PTCY and ATG for patients receiving unrelated donor PBSCT. PTCY-based prophylaxis promises to have beneficial net effects on immune reconstitution, GVHD and disease control, and thus might impact on patient survival.

NCT ID: NCT05025098 Recruiting - MDS Clinical Trials

Precision Therapy Versus Standard Therapy in AML and MDS in Elderly

PALM
Start date: June 22, 2021
Phase: Phase 2
Study type: Interventional

This is a randomized clinical trial that randomizes between treatment principles. The study will investigate if precision therapy determined by a tumour board is better than standard treatment for acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS) in elderly. The tumour board will decide the precision therapy based on identified genetic changes that can guide customized therapy. There are currently 40-50 targeted therapies approved for various cancers in Norway. The precision therapy will be given in addition to the standard treatment. The primary study objective will be to evaluate the cost-effectiveness of a precision therapy strategy compared with standard treatment. Other objectives will mesaure efficacy and satety of the treatment, and impact on life quality of the patients.

NCT ID: NCT05009537 Recruiting - MDS Clinical Trials

Optical Genome Mapping in Hematological Malignancies

CARTOGEN
Start date: September 2021
Phase:
Study type: Observational

Establish the diagnostic potential of optical genome mapping in patients with suspected hematologic cancer

NCT ID: NCT04901416 Recruiting - MDS Clinical Trials

Safety and Efficacy of Allogeneic NK Cell Infusions in Patients With Relapsed/Refractory AML and High Risk MDS

Start date: December 15, 2021
Phase: Phase 1
Study type: Interventional

This study involves the use of an investigational cell therapy known as DVX201. DVX201 is an investigational cell therapy that contains a type of white blood cell called natural killer (NK) cells. NK cells are a normal part of your immune system and have a lifespan of only about two weeks. They are called natural killer cells because they have the natural ability to identify and kill cells in the body that are abnormal, like cancer cells or virally infected cells. But fighting cancer can also lead to exhaustion and abnormal function of NK cells. It can also result in a significant decrease in the number of NK cells in the blood, making it more difficult for the immune system to control the disease. We believe that infusion of healthy, functional NK cells into patients with AML or MDS may boost the immune system and help by killing cancer cells that remain after chemotherapy. DVX201 is an investigational NK cell therapy that may provide a rapid and temporary source of healthy NK cells that are better able to fight those cancer cells.

NCT ID: NCT04898790 Recruiting - Multiple Myeloma Clinical Trials

Improving Cognitive Function in Older Adults Undergoing Stem Cell Transplant

PROACTIVE
Start date: November 18, 2021
Phase: N/A
Study type: Interventional

Cancer and treatment-related cognitive changes hinder resumption of normal routine and roles and worsen quality of life. Older adults undergoing hematopoietic cell transplantation (HCT) are at high-risk for cognitive impairment. Physical activity improves cognitive function in older adults and survivors of other cancers. We hypothesize that increasing physical activity can also improve cognitive function in this vulnerable population. The objective of this research is to adapt and test an evidence-based physical activity intervention, The Community Health Activities Model Program for Seniors II (CHAMPS II), in the HCT setting for adults 60 years and older. Aim 1: Adapt the CHAMPS-II manual and develop study materials using feedback from up to 10 patient/care-partner dyads who have experienced the HCT process within the last 3-6 months and HCT team members via semi-structured interviews. Aim 2: Iteratively adapt and implement CHAMPS-II intervention in three waves (2-6 patient/care-partner dyads per wave). The dyads will participate in a multi-phase, light to moderate-intensity physical activity program through Day 100 post-HCT. Aim 3: Test the preliminary effectiveness of the adapted intervention to improve cognitive function compared to a wait-list control condition (N = 34 per group) in a 2-arm, pilot randomized controlled trial. Primary and secondary outcomes will include subjective and objective cognitive function using a short battery of neuropsychological tests and a self-report questionnaire. Tertiary outcomes comprise subjective and objective measures of physical activity behavior and physical function. The RE-AIM framework will be utilized for formative and process evaluation during the adaptation process and implementation of the intervention.

NCT ID: NCT04730258 Recruiting - Clinical trials for Acute Myeloid Leukemia

A Study of CFI-400945 With or Without Azacitidine in Patients With AML, MDS or CMML

TWT-202
Start date: April 16, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to test the safety of an investigational drug called CFI-400945 alone and in combination with azacitidine.