Clinical trials: Higher-Risk Myelodysplastic Syndrome
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 Myelogenous Leukemia, Myelodysplastic Syndrome
Safety, Tolerability and Pharmacokinetics of Milademetan Alone and With 5-Azacitidine (AZA) in Acute Myelogenous Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
This study will take place in parts: Dose Escalation (Part 1): Participants receive milademetan alone with different dose schedules Dose Escalation (Part 1A): Participants receive milademetan in combination with 5-azacytidine…
- Trial name
- NCT02319369
- Testing
- Milademetan, AZA
- Where
- 5 sites in United States
- Volunteers
- 74 people
- Sponsor
- Daiichi Sankyo
Myelodysplastic Syndrome (MDS)
STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS
The main objective of this study was to assess the safety profile of MBG453 (sabatolimab) in combination with FDA approved hypomethylating agents (HMAs) of investigator's choice (IV Decitabine or Azacitidine /SC Azacitidine /Oral…
- Trial name
- NCT04878432
- Testing
- MBG453, Azacitidine, Decitabine
- Where
- 15 sites in United States
- Volunteers
- 39 people
- Sponsor
- Novartis Pharmaceuticals
Leukemia, Myeloid, Acute
A Phase 1, Open Label Study of Intravenous GSK3745417 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Determine RP2D & Schedule in Participants With Relapsed or Refractory Myeloid Malignancies Including AML and HR MDS
This is a Phase 1, open label, two-part study to determine recommended phase 2 dose (RP2D) and schedule of GSK3745417 administration in participants with relapsed/refractory AML or HR-MDS.
- Trial name
- NCT05424380
- Testing
- GSK3745417
- Where
- 10 sites in Canada, Germany and 3 more
- Volunteers
- 18 people
- Sponsor
- GlaxoSmithKline
Myelodysplastic Syndrome (MDS)
Study of Azacitidine to Evaluate Safety and Effectiveness for Chinese Patients With Higher Risk Myelodysplastic Syndrome
The purpose of the study is to determine whether azacitidine is safe and effective in the treatment of Chinese patients with higher risk Myelodysplastic Syndromes (MDS).
- Trial name
- NCT01599325
- Testing
- Azacitidine
- Where
- 11 sites in China
- Volunteers
- 72 people
- Sponsor
- Celgene
AML and High Risk MDS
A Safety and Efficacy Study of LGH447 in Patients With Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)
This study will assess the safety and preliminary efficacy of escalating doses of LGH447 monotherapy in AML and MDS and LGH447 in combination with midostaurin in AML.
- Trial name
- NCT02078609
- Testing
- LGH447, LGH447 + midostaurin
- Where
- 9 sites in United States, Australia and 5 more
- Volunteers
- 70 people
- Sponsor
- Novartis Pharmaceuticals
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.
Myelodysplastic Syndromes, Leukemia, Myeloid, Acute
A Study Comparing Treatment Preference Between Oral Decitabine/Cedazuridine and Azacitidine in Myelodysplastic Syndrome, Low-Blast Acute Myeloid Leukemia, or Chronic Myelomonocytic Leukemia
It is hypothesized that significantly more patients would prefer oral decitabine/cedazuridine to subcutaneous (SC) azacitidine (AZA) due to several factors, including improved treatment convenience, the reduced risk of nosocomial…
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Chronic, Patient Preference
- Trial name
- PREFER-HMA (NCT05883956)
- Testing
- Subcutaneous azacitidine, Oral decitabine/cedazuridine
- Where
- 11 sites in Australia, New Zealand
- Volunteers
- 13 people
- Sponsor
- Otsuka Australia Pharmaceutical Pty Ltd
Acute Myeloid Leukemia, High-Risk and Very High-Risk Myelodysplastic Syndromes
Study of SGR-2921 in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) and/or recommended dose (RD) of SGR-2921.
- Trial name
- NCT05961839
- Testing
- SGR-2921
- Where
- 12 sites in United States
- Volunteers
- 66 people
- Sponsor
- Schrödinger, Inc.
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
A Study of CC-90002 in Subjects With Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (MDS)
Study CC-90002-AML-001 is an open-label, Phase 1 dose escalation (Part A) and expansion (Part B), clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects with relapsed and/or primary refractory AML and…
- Trial name
- NCT02641002
- Testing
- CC-90002
- Where
- 6 sites in United States
- Volunteers
- 28 people
- Sponsor
- Celgene
High-risk Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (CMML)
A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias
Study CBX-250-001 is a Phase 1, open-label, dose-escalation study of CBX-250 in participants with relapsed/refractory AML, HR-MDS, CMML, and CML. Participants aged ≥ 12 years are planned to be enrolled.
- Conditions
- High-risk Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (CMML), AML - Acute Myeloid Leukemia, Chronic Myeloid Leukemia
- Trial name
- CROSSCHECK-001 (NCT06994676)
- Testing
- CBX-250
- Where
- 11 sites in United States
- Volunteers
- 72 people
- Sponsor
- Crossbow Therapeutics, Inc.
Hematologic Malignancies
Safety Study of Gene Modified Donor T-Cells in Adults With Advanced Hematologic Malignancies
This is an open-label, non-randomized study to evaluate the safety of two planned infusions of BPX-501 T cells after partially mismatched, related (haploidentical) HSCT in adults with hematologic malignancies.
- Trial name
- NCT02487459
- Testing
- BPX-501, AP1903
- Where
- United States
- Sponsor
- Bellicum Pharmaceuticals
Acute Myeloid Leukemia, Myelodysplastic Syndrome
Safety and Proof-of-Concept Study of RPT1G in Adults With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes
The main goals of this study are to learn if RPT1G is safe and tolerable and to determine the best dose and schedule of RPT1G for patients with relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic…
- Trial name
- NCT07107126
- Testing
- RPT1G
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Remedy Plan, Inc.
Myelodysplastic Syndrome (MDS), Chronic Myelomonocytic Leukemia (CMML)
Study of Azacitidine With or Without Birinapant in Subjects With MDS or CMMoL
This is a randomized double blind placebo controlled study of azacitidine with or without birinapant in subjects with higher risk Myelodysplastic syndrome, secondary MDS or myelomonocytic leukemia (CMMoL) who are naïve, to…
- Trial name
- NCT02147873
- Testing
- birinapant, Azacitidine
- Where
- 76 sites in United States, Australia and 2 more
- Volunteers
- 118 people
- Sponsor
- TetraLogic Pharmaceuticals
Acute Myeloid Leukemia, B-cell Acute Lymphoblastic Leukemia
Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies
Dose Escalation - Determine the maximum tolerated dose (MTD), if possible, or minimum optimal biologic dose (OBD), and evaluate the safety and tolerability of VIP943 in subjects with advanced CD123+ hematologic malignancies
- Conditions
- Acute Myeloid Leukemia, B-cell Acute Lymphoblastic Leukemia, High-risk Myelodysplastic Syndrome
- Trial name
- NCT06034275
- Testing
- VIP943 (QW), VIP943 (BIW)
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- Vincerx Pharma, Inc.
Leukemia, Myelodysplastic Syndromes
VNP40101M in Treating Patients With Acute Myelogenous Leukemia or High-Risk Myelodysplasia
RATIONALE: Drugs used in chemotherapy, such as VNP40101M and hydroxyurea, work in different ways to stop cancer cells from dividing so they stop growing or die.
- Conditions
- Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
- Trial name
- NCT00083187
- Testing
- hydroxyurea, laromustine
- Where
- 5 sites in United States, France and 1 more
- Volunteers
- 230 people
- Sponsor
- Vion Pharmaceuticals
Myelodysplastic Syndromes, Myelogenous Leukemia, Acute
A Study of Vismodegib in Patients With Relapsed/Refractory Acute Myelogenous Leukemia and Relapsed Refractory High-Risk Myelodysplastic Syndrome
This study will assess the safety and efficacy of vismodegib in patients with relapsed/refractory acute myelogenous leukemia (AML) and relapsed/refractory high-risk myelodysplastic syndrome (MDS).
- Trial name
- NCT01880437
- Testing
- cytarabine, vismodegib
- Where
- 14 sites in United States, Canada and 1 more
- Volunteers
- 38 people
- Sponsor
- Hoffmann-La Roche
Thrombocytopaenia
A Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-risk Myelodysplastic Syndromes (MDS)
Eltrombopag olamine (SB-497115-GR) is an orally bioavailable, small molecule thrombopoietin receptor agonist that may be beneficial in medical disorders associated with thrombocytopenia.
- Trial name
- NCT02158936
- Testing
- Eltrombopag, Azacitidine
- Where
- 155 sites in United States, Argentina and 28 more
- Volunteers
- 356 people
- Sponsor
- Novartis Pharmaceuticals
Paroxysmal Nocturnal Hemoglobinuria, Natural History Study
Natural History Study of Adult Patients With Paroxysmal Nocturnal Hemoglobinuria of High-risk Hemolysis in China
This is a single-center observational study conducted in adult patients with paroxysmal nocturnal hemoglobinuria of high-risk hemolysis.
- Trial name
- NCT05125341
- Where
- China
- Volunteers
- 67 people
- Sponsor
- CARE Pharma Shanghai Ltd.
Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia
A Study of Bisantrene Combined With Cytarabine or With Decitabine for Adult Subjects With Extramedullary AML and MDS
This is a two strata Phase 1b study to assess the safety and efficacy of bisantrene (RC110) in combination with a) cytarabine arabinoside (Ara-C) treatment for patients with relapsed or refractory (R/R) Acute Myeloid Leukemia…
- Conditions
- Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Higher Risk Myelodysplastic Syndrome
- Trial name
- BISECT (NCT05456269)
- Testing
- Bisantrene Dihydrochloride (high dose), Bisantrene Dihydrochloride (low dose), Cytarabine Hydrochloride
- Where
- Australia
- Sponsor
- Racura Oncology Ltd