Clinical trials: Higher-Risk Myelodysplastic Syndrome
AML, Adult
A Study of APG-2575 in Combination With Azacitidine in Patients With Acute Myeloid Leukemia (AML)
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.
- Trial name
- NCT04964518
- Testing
- APG 2575 ramp up arm
- Where
- 9 sites in United States, Australia
- Volunteers
- 24 people
- Sponsor
- Ascentage Pharma Group Inc.
AML, Adult, MDS
Phase 2, Open-Label, Single Arm Study, With BST-236 in Adults With R/R AML or Higher-Risk MDS
An open label multi center study to assess the safety and efficacy of BST-236 as single agent in adult patients unfit for standard therapy with Acute Myeloid Leukemia (AML) or higher-risk (HR) Myelodysplastic Syndromes (MDS) who…
- Conditions
- AML, Adult, MDS, Relapse/Recurrence, Refractory Acute Myeloid Leukemia
- Trial name
- NCT04749355
- Testing
- BST-236
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- BioSight Ltd.
Acute Myelogenous Leukemia
Dose Escalation, Safety and Pharmacokinetic Study of SAR103168 in Patients Refractory/ Relapsed Acute Leukemias or High-risk Myelodysplastic Syndromes
Primary objectives: To determine the maximum tolerated dose (MTD) of SAR103168 and to characterize the dose limiting toxicities (DLTs) in the proposed dose regimen To evaluate the pharmacokinetic (PK) profile of SAR103168…
- Trial name
- NCT00981240
- Testing
- SAR103168
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Sanofi
Myelodysplastic Syndrome
A Trial of AK117 (Anti-CD47) in Patients With Myelodysplastic Syndrome
This is a open label, phase I/II study. All patients are diagnosed with higher-risk MDS, Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Trial name
- NCT04900350
- Testing
- AK117, Azacitidine
- Where
- China
- Volunteers
- 136 people
- Sponsor
- Akeso
Myelodysplastic Syndrome (MDS)
A Phase 1 Study of AMV564 in Patients With Intermediate or High-Risk Myelodysplastic Syndromes
An open label, Phase 1, study of AMV564 as monotherapy to assess the safety and efficacy in patients with Myelodysplastic Syndromes
- Trial name
- NCT03516591
- Testing
- AMV564 14-Day CIV
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- Amphivena Therapeutics, Inc.
Myelodysplastic Syndrome, Acute Myeloid Leukemia
A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients
This multi center open label Phase 1b study is designed to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of glasdegib (PF-04449913) when combined with azacitidine in patients with previously…
- Conditions
- Myelodysplastic Syndrome, Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia
- Trial name
- BRIGHT 1012 (NCT02367456)
- Testing
- PF-04449913 (Glasdegib), Azacitidine
- Where
- 33 sites in United States, Belgium and 4 more
- Volunteers
- 73 people
- Sponsor
- Pfizer
Myelodysplastic Syndromes
Safety and Efficacy of IBI188 With Azacitidine in Subjects With Newly Diagnosed Higher Risk MDS
The study is to evaluate safety and efficacy of IBI188 in combination with azacitidine (AZA) as a first-line treatment in subjects with newly diagnosed higher risk myelodysplastic syndrome
- Trial name
- NCT04485065
- Testing
- IBI188+azacitidine
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Acute Myeloid Leukemia, Myelodysplastic Syndromes
A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes
The goal of this phase 1/2 multicenter, open-label, single-arm dose escalation and expansion study is to assess the safety, tolerability, pharmacokinetic and pharmacodynamic profile of CTX-712 in patients with relapsed/refractory…
- Trial name
- NCT05732103
- Testing
- CTX-712
- Where
- 8 sites in United States
- Volunteers
- 225 people
- Sponsor
- Chordia Therapeutics, Inc.
Acute Myeloid Leukemia, Myelodysplastic Syndromes
PRGN-3006 Adoptive Cellular Therapy for CD33-Positive Relapsed or Refractory AML, MRD Positive AML or Higher Risk MDS
This is a first-in-human dose escalation/dose expansion study to evaluate the safety and identify the best dose of modified immune cells, PRGN-3006 (autologous chimeric antigen receptor (CAR) T cells), in adult patients with…
- Trial name
- NCT03927261
- Testing
- PRGN-3006 T Cells
- Where
- 2 sites in United States
- Volunteers
- 88 people
- Sponsor
- Precigen, Inc
Myelodysplastic Syndrome
Safety Study of Mocetinostat in Combination With Azacitidine in Subjects With MDS
Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. Azacitidine is a hypomethylating agent (HMA) used to treat MDS.
- Trial name
- NCT02018926
- Testing
- Mocetinostat, Azacitidine
- Where
- 10 sites in United States
- Volunteers
- 18 people
- Sponsor
- Mirati Therapeutics Inc.
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
Allogeneic Engineered Hematopoietic Stem Cell Transplant (HCT) Lacking the CD33 Protein, and Post-HCT Treatment With Mylotarg, for Patients With CD33+ AML or MDS
This is a Phase 1/2a, multicenter, open-label, first-in-human (FIH) study of VOR33 in participants with AML or MDS who are undergoing human leukocyte antigen (HLA)-matched allogeneic hematopoietic cell transplant (HCT).
- Trial name
- NCT04849910
- Testing
- VOR33, Mylotarg
- Where
- 15 sites in United States, Canada
- Volunteers
- 67 people
- Sponsor
- Vor Biopharma
Chronic Myelogenous Leukemia, Ph1-Positive, Acute Myeloid Leukemia
Clinical Trial of BP1001 (Liposomal Grb2 Antisense Oligonucleotide) in Combination With Dasatinib in Patients With Ph + CML Who Have Failed TKI, Ph+ AML, Ph+ MDS
The primary objective of the Phase Ib study is to determine the dose-limiting toxicity (DLT) and maximal tolerated dose (MTD) of BP1001 in combination with dasatinib in patients with with Philadelphia Chromosome Positive (Ph+)…
- Conditions
- Chronic Myelogenous Leukemia, Ph1-Positive, Acute Myeloid Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT02923986
- Testing
- BP1001 (varying dose), BP1001 (fixed dose), Dasatinib
- Where
- United States
- Sponsor
- Bio-Path Holdings, Inc.
Myelodysplastic Syndrome
Efficacy and Safety of 5-day Dosing of ON 01910.Na in Intermediate-1,-2, or High Risk Myelodysplastic Syndrome (MDS)
For MDS patients who have not responded to or have progressed after an initial response to DNA methyltransferase inhibitors (DNMTI) and are not stem cell transplant candidates, therapeutic options are limited.
- Trial name
- NCT00867061
- Testing
- ON 01910.Na Concentrate
- Where
- United States
- Sponsor
- Traws Pharma, Inc.
Acute Myeloid Leukemia, Myelodysplastic Syndromes
A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS
This study is being done to evaluate the safety, tolerability and antitumor activity of oral CG-806 (luxeptinib) for the treatment of patients with Acute Myeloid Leukemia (except APML), secondary AML, therapy-related AML, or…
- Trial name
- NCT04477291
- Testing
- CG-806
- Where
- 10 sites in United States
- Volunteers
- 45 people
- Sponsor
- Aptose Biosciences Inc.
Leukemia, Myelodysplastic Syndromes
Study of Matched Unrelated Donor T Cell Infusion for Hematologic Malignancies After Allo-HSCT
This is a Phase I, multicenter, open-label, non-randomized study of matched unrelated donor BPX-501 T cell infusion in adult subjects with hematological malignancies presenting with recurrent disease minimal residual disease…
- Conditions
- Leukemia, Myelodysplastic Syndromes, Lymphomas, Multiple Myeloma
- Trial name
- NCT02786485
- Testing
- rivogenlecleucel, Rimiducid
- Sponsor
- Bellicum Pharmaceuticals
Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS)
A Phase Ib Study of APG-115 Single Agent or in Combination With Azacitidine or Cytarabine in Patients With AML and MDS.
Acute myeloid leukemia is a malignant disorder characterized by the rapid, uncontrolled proliferation of malignant clonal hematopoietic stem cells that accumulate as immature, undifferentiated cells (blasts) in the bone marrow…
- Trial name
- NCT04275518
- Testing
- APG-115, Azacitidine, Cytarabine
- Where
- 14 sites in China
- Volunteers
- 102 people
- Sponsor
- Ascentage Pharma Group Inc.
Myelodysplastic Syndromes
Expanded Access Program With Pevonedistat (Given With Azacitidine) for Adults With Higher-risk Myelodysplastic Syndromes
Participants in the expanded access program are adults with higher-risk myelodysplastic syndromes who have no other treatment options available.
- Trial name
- NCT04484363
- Testing
- Pevonedistat, Azacitidine
- Sponsor
- Takeda
High Risk Hematological Malignancy, Cord Blood Transplant
US Study of UM171-Expanded CB in Patients With High Risk Leukemia/Myelodysplasia
Cord blood (CB) transplants are an option for patients lacking an HLA identical donor but are hampered by low cell dose, prolonged aplasia and high transplant related mortality.
- Trial name
- NCT04103879
- Testing
- ECT-001-CB (UM171-Expanded Cord Blood Transplant)
- Where
- 3 sites in United States, Netherlands
- Volunteers
- 30 people
- Sponsor
- ExCellThera inc.
Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML)
Pharmacokinetics, Tolerability and Safety of NEX-18a
The study will evaluate the safety, tolerability and pharmacokinetics of NEX-18a, a long-acting injectable azacitidine, in patients diagnosed with intermediate 2 or higher-risk MDS, CMML, or AML and already on treatment with…
- Conditions
- Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), Acute Myeloid Leukemia (AML)
- Trial name
- NCT05048498
- Testing
- NEX-18a injection, Azacitidine Injection
- Where
- 2 sites in Sweden
- Volunteers
- 2 people
- Sponsor
- Nanexa AB
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
An Efficacy and Safety Study of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Adults With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly Patients With Acute Myeloid Leukemia (AML)
The primary objective of this study is to evaluate the efficacy of subcutaneous azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in adults with previously untreated, higher risk MDS who…
- Trial name
- NCT02775903
- Testing
- Azacitidine, Durvalumab
- Where
- 103 sites in United States, Austria and 10 more
- Volunteers
- 213 people
- Sponsor
- Celgene