Clinical trials: Myelodysplastic Syndromes
MDS (Myelodysplastic Syndrome)
Luspatercept + Darbepoetin in MDS
This is a single arm open-label Phase II trial of luspatercept and darbepoetin alfa in non-mutated SF3B1 , lower-risk, RBC transfusion dependent MDS participants with an endogenous erythropoietin (EPO) level < 500 IU/L.
- Trial name
- DarbeLus (NCT07096297)
- Testing
- Luspatercept, Darbeopoetin
- Where
- 4 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Yale University
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Biphenotypic Leukemia
Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts From HLA-Matched Related and Unrelated Donors in Preventing GVHD
This phase II trial is for patients with acute lymphocytic leukemia, acute myeloid leukemia, myelodysplastic syndrome or chronic myeloid leukemia who have been referred for a peripheral blood stem cell transplantation to treat…
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Biphenotypic Leukemia, Acute Leukemia of Ambiguous Lineage, Acute Undifferentiated Leukemia
- Trial name
- NCT02220985
- Testing
- Allogeneic Hematopoietic Stem Cell Transplantation, Cyclophosphamide, Fludarabine Phosphate
- Where
- 2 sites in United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Fred Hutchinson Cancer Center
Paroxysmal Nocturnal Hemoglobinuria
A Study to Test if SAR443809 is Tolerated and Safe When Taken as a Single Dose in Healthy Adults
Primary objective The tolerability and safety of SAR443809 Secondary The PK parameters of SAR443809 The PD activity of SAR443809 The immunogenicity of SAR443809
- Trial name
- NCT06326814
- Testing
- Humanized anti-Factor Bb monoclonal antibody
- Where
- 2 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Sanofi
Allogeneic Hematopoietic Cell Transplantation (HCT), Advanced Hematologic Malignancies
Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft
Reduced intensity conditioning (RIC) has emerged and been increasingly adopted as a modality to allow preparative conditioning pre transplant to be tolerated by older adults or those patients that are otherwise unfit for…
- Conditions
- Allogeneic Hematopoietic Cell Transplantation (HCT), Advanced Hematologic Malignancies, Acute Leukemia, Chronic Myelogenous Leukemia
- Trial name
- NCT05088356
- Testing
- Purified regulatory T-cells (Treg) plus CD34+ HSPC, Fludarabine, Melphalan
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Stanford University
Paroxysmal Nocturnal Hemoglobinuria, PNH, Complement-mediated Kidney Disease
A Phase I Clinical Trial to Evaluate CMS-D017 Following Single and Multiple Doses in Healthy Participants
This study is a first-in-human (FIH) trial of CMS-D017 conducted in healthy Chinese adult participants, consisting of two parts: Part 1-a single ascending dose (SAD) study (referred to as Part 1 SAD), and Part 2-a multiple…
- Trial name
- NCT07462780
- Testing
- CMS-D017 Capsule
- Where
- China
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Shenzhen Kangzhe Biotechnology Co., Ltd.
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
This phase II clinical trial tests how well the cytomegalovirus-modified vaccinica Ankara (CMV-MVA) Triplex vaccine given to human leukocyte antigens (HLA) matched related stem cell donors works to prevent cytomegalovirus (CMV)…
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Chronic Myeloid Leukemia, BCR-ABL1 Positive
- Trial name
- NCT06059391
- Testing
- Allogeneic Hematopoietic Stem Cell Transplantation, Biospecimen Collection, Granulocyte Colony-Stimulating Factor
- Where
- 3 sites in United States
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- City of Hope Medical Center
Acute Myelogenous Leukemia
Randomized Study of Haploidentical Hct and Subsequent Donor nk Cell Infusion in High-risk AML and MDS
This is a single center, open label, random comparison phase 2b study. The primary objective of this study is, by random comparison, to assess the anti-leukemia effect of allogeneic, donor-derived natural killer (NK) cells…
- Trial name
- DNKI-4 (NCT02477787)
- Testing
- allogeneic, donor-derived NK cells
- Where
- South Korea
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Asan Medical Center
Paroxysmal Nocturnal Hemoglobinuria
To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Single and Multiple Doses of KP104
The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of KP104 in healthy volunteers.
- Trial name
- NCT05490017
- Testing
- KP104
- Where
- Australia
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Kira Pharmacenticals (US), LLC.
Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia
Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS
This phase II trial studies the effect of venetoclax together with busulfan, cladribine, and fludarabine in treating patients with high-risk acute myeloid leukemia or myelodysplastic syndrome who are undergoing stem cell…
- Conditions
- Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT04708054
- Testing
- Busulfan, Cladribine, Fludarabine Phosphate
- Where
- United States
- Volunteers
- 324 people, healthy volunteers welcome
- Sponsor
- M.D. Anderson Cancer Center
Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia
A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant
This phase Ib trial tests the safety, side effects, and how well cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) Triplex vaccine works in enhancing CMV-specific immunity and preventing CMV viremia in patients undergoing…
- Conditions
- Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia
- Trial name
- NCT07020533
- Testing
- Biospecimen Collection, Electronic Health Record Review, Haploidentical Hematopoietic Cell Transplantation
- Where
- 3 sites in United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- City of Hope Medical Center
Leukemia, Lymphoma
Centralized Cord Blood Registry to Facilitate Unrelated Cord Blood Transplantation
The National Marrow Donor Program (NMDP) has established a system for registering, matching, and tracking unrelated donor cord blood units (CBUs) and transplant outcomes.
- Conditions
- Leukemia, Lymphoma, Myelodysplastic Syndromes
- Trial name
- NCT00737516
- Testing
- HPC, Cord Blood
- Where
- 19 sites in United States
- Volunteers
- 3,621 people, healthy volunteers welcome
- Sponsor
- National Marrow Donor Program
IgA Nephropathy, Paroxysmal Nocturnal Hemoglobinuria
A Clinical Study to Evaluate the Effect of Food on the Pharmacokinetic Profiles of HRS-5965 Capsules in Healthy Subjects
The study is being conducted to evaluate the effect of food on pharmacokinetics of HRS-5965 capsules after oral administration.
- Trial name
- NCT07035665
- Testing
- HRS-5965 Capsules
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Chengdu Suncadia Medicine Co., Ltd.
Lymphoma, Leukemia
Transfer of Effector Memory T Cells (Tem) Following Allogeneic Stem Cell Transplantation
RATIONALE: Following stem cell transplantation, a major risk is graft-versus-host disease (GVHD). This occurs when donor immune cells that have been infused recognise the host's cells as 'foreign' and attack these cells.
- Conditions
- Lymphoma, Leukemia, Myeloma, Myelodysplastic Syndromes
- Trial name
- ToTem (NCT03836690)
- Testing
- CD62L- Tem
- Where
- United Kingdom
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University College, London
Clonal Hematopoiesis, Clonal Hematopoiesis of Indeterminate Potential
CHIP in Health and Disease
Clonal hematopoiesis (CH), including clonal hematopoiesis of indeterminate potential (CHIP), is an age-associated condition characterized by the expansion of hematopoietic stem and progenitor cell clones carrying acquired somatic…
- Conditions
- Clonal Hematopoiesis, Clonal Hematopoiesis of Indeterminate Potential, Clonal Cytopenia of Undetermined Significance (CCUS), Myelodysplastic Syndrome
- Trial name
- CHIP2 (NCT07780552)
- Where
- Austria
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- VASCage GmbH
Paroxysmal Nocturnal Hemoglobinuria
Effect of Food on Pharmacokinetics of MY008211A Tablets in Healthy Adult Subjects
This was a single-center, single-dose, open-label clinical study. 12 subjects were randomly assigned in a 1:1 ratio to one of the following dosing sequences (sequence 1: AB; Sequence 2: BA).
- Trial name
- NCT05828485
- Testing
- MY008211A tablets
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Wuhan Createrna Science and Technology Co., Ltd
Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia
A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia.
To learn if olutasidenib can help to control CCUS, MDS, and/or CMML. The safety of the drug will also be studied.
- Conditions
- Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Clonal Cytopenia of Undetermined Significance
- Trial name
- NCT06566742
- Testing
- Olutasidenib
- Where
- 2 sites in United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- M.D. Anderson Cancer Center
Myelodysplastic Syndromes
Transfusion Effects in Myelodysplastic Patients: Limiting Exposure
The goal of this study was to compare a restrictive RBC transfusion policy (a Hb transfusion trigger: 7.2 gr/dl) with a more liberal RBC transfusion policy (a Hb transfusion trigger: 9.6 gr/dl) on physical fatigue.
- Trial name
- NCT00202371
- Testing
- Red Blood Cell transfusion
- Where
- Netherlands
- Volunteers
- healthy volunteers welcome
- Sponsor
- Sanquin Research & Blood Bank Divisions
Myelodysplastic Syndromes, Acute Myeloid Leukemia
Constitution of a Biological Cohort Following Bone Marrow Sampling From MDS or AML Patients and Age-matched Healthy Donors
It is of clinical significance to better characterize the intrinsic defects harbored by mesenchymal stromal cells (MSC) in Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) context, as compared to physiological…
- Conditions
- Myelodysplastic Syndromes, Acute Myeloid Leukemia, Cardio-vascular Surgery
- Trial name
- COSMOS (NCT03233074)
- Testing
- Bone marrow analyses
- Where
- 2 sites in France
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Myelodysplastic Syndromes
Sterile Inflammation and Molecular Aberrations in MDS
The objective of this study is the description of the possible association between genetic mutation/aberration profiles, inflammatory tonus and clinical phenotype based on PROMs and HRQoL.
- Trial name
- InflamGen (NCT04313231)
- Testing
- Next Generation Sequencing, Tumorimmunological examinations - multiplex assays/quantitative polymerase chain reaction, flow cytometry
- Where
- Austria
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Medical University Innsbruck
AML (Acute Myeloid Leukemia), MDS/AML
Venetoclax- Augmented Treosulfan-Based Reduced Intensity Conditioning Before Allogeneic Stem Cell Transplantation
Safety and Feasibility of a Venetoclax- Augmented Treosulfan-Based Reduced Intensity Conditioning Before Allogeneic Stem Cell Transplantation in AML, MDS/AML and Higher Risk MDS
- Conditions
- AML (Acute Myeloid Leukemia), MDS/AML, MDS (Myelodysplastic Syndrome)
- Trial name
- NCT07214064
- Testing
- RIC regimen
- Where
- Germany
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- University Hospital Tuebingen