Clinical trials: High-risk Myelodysplastic Syndromes
AML, MDS
Study of APVO436 in Patients With AML or MDS
The primary objective of the Phase 1 part of the study is to determine the recommended dose of APVO436 administered intravenously to patients with AML or MDS.
- Trial name
- NCT03647800
- Testing
- APVO436
- Where
- 12 sites in United States
- Volunteers
- 136 people
- Sponsor
- Aptevo Research and Development LLC
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
Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia
Study of Hypoxia-Activated Prodrug TH-302 to Treat Advanced Leukemias
The primary objective of this study is to determine the maximum tolerated dose, dose limiting toxicity, safety and tolerability of TH-302 in patients with acute leukemias, advanced phase chronic myelogenous leukemia (CML), high…
- Conditions
- Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, High-risk Myelodysplastic Syndrome
- Trial name
- NCT01149915
- Testing
- TH-302
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Threshold Pharmaceuticals
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
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
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics Inc
Myelodysplastic Syndrome
Study of Tipifarnib in Patients With High-Risk Myelodysplastic Syndrome (MDS)
The purpose of this study is to characterize the hematological response rate, as well as other parameters of efficacy and safety induced by tipifarnib in patients with high-risk myelodysplastic syndrome (MDS).
- Trial name
- NCT00050154
- Testing
- ZARNESTRA, tipifarnib, R115777
- Volunteers
- 82 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Myelodysplastic Syndromes
To Demonstrate Superiority of Decitabine Over Azacitidine in Subjects With Intermediate- or High-risk MDS.
The purpose of this study is to compare the response of patients with Intermediate or High Risk myelodysplastic syndromes (MDS) following treatment with decitabine or azacitidine.
- Trial name
- NCT01011283
- Testing
- decitabine, azacitidine
- Where
- 19 sites in United States
- Volunteers
- 26 people
- Sponsor
- Eisai Inc.
Myelodysplastic Syndrome, Acute Myelogenous Leukemia
A Phase I/II Study of MGCD0103 With Azacitidine in Patients With High-Risk Myelodysplastic Syndrome (MDS) or Acute Myelogenous Leukemia
In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly in combination with azacitidine to patients with high-risk myelodysplastic syndromes or acute myelogenous leukemia.
- Trial name
- NCT00324220
- Testing
- MGCD0103
- Where
- 8 sites in United States
- Volunteers
- 66 people
- Sponsor
- Mirati Therapeutics Inc.
Myelodysplastic Syndromes
A Study of Oral Decitabine/Cedazuridine in Combination With Magrolimab in Participants With Intermediate- to Very High-Risk Myelodysplastic Syndromes (MDS)
The primary purpose of the study is to evaluate the preliminary safety and efficacy of oral decitabine/cedazuridine in combination with magrolimab.
- Trial name
- NCT05835011
- Testing
- Decitabine/Cedazuridine, Magrolimab
- Where
- 3 sites in United States
- Volunteers
- 2 people
- Sponsor
- Astex Pharmaceuticals, 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, Leukemia, Myelomonocytic, Chronic
A Study of Azacitidine in Participants With International Prognostic Scoring System (IPSS) Intermediate-2 and High-risk Myelodysplastic Syndromes (MDS), or Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)
The purpose of this study is to assess the safety and effectiveness in the real-world setting among participants who are treated with Azacitidine in accordance with the China Product Label.
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
- Trial name
- DIM Vidaza (NCT05218902)
- Where
- China
- Volunteers
- 290 people
- Sponsor
- Bristol-Myers Squibb
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.
Leukemia, Leukemia, Myeloid
A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome
Study BH-30236-01 is a first-in-human (FIH), Phase 1/1b, open-label, dose escalation and expansion study in participants with relapsed/refractory acute myelogenous leukemia (R/R AML) or higher-risk myelodysplastic syndrome…
- Conditions
- Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Preleukemia
- Trial name
- NCT06501196
- Testing
- BH-30236, Venetoclax
- Where
- 13 sites in United States
- Volunteers
- 170 people
- Sponsor
- BlossomHill Therapeutics
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.
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
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
RVU120 in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome
This first-in-human study will evaluate RVU120 (SEL120), a novel small molecule CDK8/19 inhibitor, in patients with Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (HR-MDS), in terms of selection of the…
- Trial name
- NCT04021368
- Testing
- RVU120(SEL120)
- Where
- 10 sites in United States, Poland
- Volunteers
- 51 people
- Sponsor
- Ryvu Therapeutics SA
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
Hematologic Malignancy, Acute Myeloid Leukemia
CLL1-CD33 cCAR in Patients With Relapsed and/or Refractory, High Risk Hematologic Malignancies
Phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CLL1-CD33 cCAR in patients with relapsed and/or refractory, high risk hematologic malignancies.
- Conditions
- Hematologic Malignancy, Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myeloproliferative Neoplasm
- Trial name
- NCT03795779
- Testing
- CLL1-CD33 cCAR T cells
- Where
- 2 sites in China
- Volunteers
- 20 people
- Sponsor
- iCell Gene Therapeutics
Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
Phase 2 Study of Azacitidine (Vidaza) vs MGCD0103 vs Combination in Elderly Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
The purpose of the study is to determine how effective azacitidine, MGCD0103, and the combination of azacitidine and MGCD0103 are in treating AML or MDS in people over 60 years of age.
- Trial name
- NCT00666497
- Testing
- Azacitidine, MGCD0103
- Where
- 8 sites in United States, Canada and 1 more
- Volunteers
- 6 people
- Sponsor
- Mirati Therapeutics Inc.