Clinical trials: Higher Risk Myelodysplastic Syndromes
High-risk Myelodysplastic Syndromes, Acute Myelogenous Leukemia
GTB-3550 Tri-Specific Killer Engager (TriKE®) for High Risk Hematological Malignancies
This is a multi-center Phase I/II clinical trial of GTB-3550 (CD16/IL-15/CD33) tri-specific killer cell engager (TriKE®) for the treatment of CD33-expressing high risk myelodysplastic syndromes, refractory/relapsed acute myeloid…
- Conditions
- High-risk Myelodysplastic Syndromes, Acute Myelogenous Leukemia, Systemic Mastocytosis, Mast Cell Leukemia
- Trial name
- NCT03214666
- Testing
- GTB-3550 TriKE® Phase I, GTB-3550 TriKE® Phase II
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- GT Biopharma, Inc.
Acute Myeloid Leukemia, in Relapse, Myelodysplastic Syndromes
Study of CB-5339 in Acute Myeloid Leukemia or Myelodysplastic Syndrome
This is a multicenter, open-label Phase 1 study of orally administered CB-5339 in participants with R/R AML or participants with R/R intermediate- to high-risk MDS.
- Trial name
- NCT04402541
- Testing
- CB-5339
- Where
- 10 sites in United States, Australia
- Volunteers
- 55 people
- Sponsor
- Cleave Therapeutics, Inc.
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
A Phase 1 Dose Escalation Study of TAK-901 in Subjects With Advanced Hematologic Malignancies
The purpose of this study is to determine the maximum tolerated dose (MTD) of TAK-901 in subjects with advanced hematological malignancies, and to further assess the safety and tolerability of TAK-901 at or below the MTD in an…
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Chronic Lymphocytic Leukemia
- Trial name
- NCT00807677
- Testing
- TAK-901
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
AML, Adult, MDS
Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML/HR-MDS and in Combination With Azacitidine in Previously Untreated HR-MDS
This is a Phase 1b open-label, multicenter, dose-escalation and randomized combination cohort study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor efficacy of…
- Trial name
- NCT06533761
- Testing
- Eganelisib, Eganelisib in combination with cytarabine, Eganelisib in combination with azacitidine
- Where
- 12 sites in United States, Spain
- Volunteers
- 105 people
- Sponsor
- Stelexis BioSciences
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.
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.
Haematological Malignancy, Acute Myeloid Leukemia
Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies
A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 (inobrodib) in patients with Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia or High Risk Myelodysplastic syndrome.
- Conditions
- Haematological Malignancy, Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma
- Trial name
- NCT04068597
- Testing
- CCS1477, Pomalidomide, Dexamethasone
- Where
- 39 sites in United States, France and 3 more
- Volunteers
- 250 people
- Sponsor
- CellCentric Ltd.
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 Syndromes
Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)
The primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate/high/very high risk…
- Trial name
- ENHANCE (NCT04313881)
- Testing
- Magrolimab, Azacitidine
- Where
- 169 sites in United States, Australia and 19 more
- Volunteers
- 539 people
- Sponsor
- Gilead Sciences
MDS, AML
Non-interventional Study With Azacitidin (Vidaza®)
The purpose of this non-interventional study is to collect data on the efficiency and safety of Azacitidin in the routine application.
- Conditions
- MDS, AML, CMMOL
- Trial name
- Piaza (NCT01192945)
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- iOMEDICO AG
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
A Study of Cusatuzumab in Combination With Azacitidine Compared With Azacitidine Alone in Patients With Higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Who Are Not Candidates for Hematopoietic Stem Cell Transplantation (HSCT)
The purpose of the study is to compare overall response rate (ORR) between treatment groups in participants with higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) who are not eligible for…
- Trial name
- NCT04264806
- Testing
- Azacitidine, Cusatuzumab
- Where
- 73 sites in Australia, Brazil and 9 more
- Sponsor
- Janssen Research & Development, LLC
Myelodysplastic Syndromes
A Survival Study in Patients With High Risk Myelodysplastic Syndromes Comparing Azacitidine Versus Conventional Care
The purpose of this study is to determine whether patients with high-risk myelodysplastic syndromes (MDS) treated with azacitidine have improved survival compared to conventional care treatments.
- Trial name
- NCT00071799
- Testing
- Azacitidine, Physician Choice
- Where
- 108 sites in United States, Australia and 13 more
- Volunteers
- 358 people
- Sponsor
- Celgene
Myelodysplastic Syndromes
Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes
Evaluate the safety and efficacy of oral azacitidne (CC-486) twice daily (BID) in subjects with myelodysplastic syndromes who failed to achieve an objective response post injectable hypomethylating agent (iHMA) treatment Reason…
- Trial name
- NCT02281084
- Testing
- Oral Azacitidine, Durvalumab
- Where
- 89 sites in United States, Australia and 8 more
- Volunteers
- 65 people
- Sponsor
- Celgene
Leukemia, Myeloid, Acute, 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
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…
- Trial name
- NCT04951778
- Testing
- CC-91633
- Where
- 9 sites in United States, Spain
- Volunteers
- 56 people
- Sponsor
- Celgene
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
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.
Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
Treatment of Elderly Patients With Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic (MD) Syndrome With Laromustine and Infusional Cytarabine
The purpose of the Phase I portion of this study is to evaluate the safety of this combination of medications and to determine the appropriate dose of VNP40101M to be used in combination with infusional cytarabine (araC) in…
- Trial name
- NCT00655395
- Testing
- Laromustine (VNP40101M) and Ara-C
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Viron Therapeutics Inc
Acute Myeloid Leukemia, Myelodysplastic Syndrome
A Study of Bomedemstat (IMG-7289/MK-3543) With and Without ATRA, in Participants With Advanced Myeloid Malignancies (IMG-7289-CTP-101/MK-3543-001)
This is an open label study of the dose and duration of an orally administered lysine-specific demethylase 1 (LSD1) inhibitor, bomedemstat, in patients with high-risk acute myeloid leukemia (AML) and high-risk myelodysplastic…
- Trial name
- NCT02842827
- Testing
- bomedemstat, tretinoin
- Where
- Australia
- Volunteers
- 45 people
- Sponsor
- Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
Higher Risk Myelodysplastic Syndromes
Bexmarilimab + Azacitidine Versus Placebo + Azacitidine in Participants With Treatment-naïve Higher-risk Myelodysplastic Syndromes
This Phase IIb study (BEXERA) will evaluate the safety and efficacy of bexmarilimab (FP-1305), an antibody targeting Clever-1, given in combination with azacitidine compared with azacitidine plus placebo in adults with…
- Trial name
- BEXERA (NCT07672769)
- Testing
- bexmarilimab (1mg/kg), azacitidine, bexmarilimab (3mg/kg)
- Where
- 35 sites in United States, Czechia and 5 more
- Volunteers
- 90 people
- Sponsor
- Faron Pharmaceuticals Ltd
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