Clinical trials: Myelodysplastic Neoplasm
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, Iron Overload
Study for the Treatment of Transfusional Iron Overload in Myelodysplastic Patients
Thirty patients were to be enrolled and 24 patients were actually enrolled into this open-label, single-arm trial designed to assess the safety and tolerability of oral deferasirox in adult transfusion dependent myelodysplastic…
- Trial name
- NCT00117507
- Testing
- Deferasirox
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
Paroxysmal Nocturnal Hemoglobinuria
A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria
This is a randomised Phase III, double-blind, multicentre, cross-over study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB12 and Soliris® in subjects with PNH.
- Trial name
- NCT04058158
- Testing
- SB12 (proposed eculizumab biosimilar), Soliris (eculizumab)
- Where
- 27 sites in India, Malaysia and 6 more
- Volunteers
- 50 people
- Sponsor
- Samsung Bioepis Co., Ltd.
Myelodysplastic Syndrome
Escalation Study to Determine Bioavailability of a Single Oral Dose of Decitabine in Patients With Myelodysplastic Syndrome (MDS)
The purpose of this study is to determine how the body absorbs decitabine when taken orally in patients with Myelodysplastic Syndrome (MDS). Safety will also be assessed for this oral dose.
- Trial name
- NCT00941109
- Testing
- decitabine
- Where
- 6 sites in United States
- Volunteers
- 12 people
- Sponsor
- Eisai 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
Neoplasms
Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents to Treat Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
This study will evaluate the safety, tolerability, and clinical activity of GSK3326595 in participants with relapsed and refractory MDS, chronic myelomonocytic leukemia (CMML), and AML.
- Trial name
- NCT03614728
- Testing
- GSK3326595, 5-Azacitidine
- Where
- 8 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- GlaxoSmithKline
Acute Myeloid Leukemia, Myelodysplastic Syndrome
Safety and Anti-Disease Activity of CHR-2797 (Tosedostat) in Elderly and/or Treatment Refractory Patients With Acute Myeloid Leukemia (AML) and Multiple Myeloma (MM)
This is an open-label, non-randomised, multi-centre phase I-II study of CHR-2797 administered orally once a day. The study involves two distinct phases: Phase I: an open-label, dose-escalating phase of the study to explore the…
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome, Multiple Myeloma
- Trial name
- NCT00689000
- Testing
- CHR-2797 (tosedostat): Aminopeptidase inhibitor
- Where
- United Kingdom
- Volunteers
- 57 people
- Sponsor
- Chroma Therapeutics
Myelodysplastic Syndromes
A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve
The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at…
- Trial name
- COMMANDS (NCT03682536)
- Testing
- Luspatercept, Epoetin alfa
- Where
- 226 sites in United States, Australia and 24 more
- Volunteers
- 363 people
- Sponsor
- Celgene
Paroxysmal Nocturnal Hemoglobinuria
Efficacy and Safety of the Combination of Pozelimab and Cemdisiran Versus Continued Eculizumab or Ravulizumab Treatment in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria
The primary objective of the study is: To evaluate the effect of pozelimab and cemdisiran combination therapy on hemolysis, as assessed by lactate dehydrogenase (LDH), after 36 weeks of treatment, in patients with PNH who switch…
- Trial name
- ACCESS 2 (NCT05131204)
- Testing
- Cemdisiran, Eculizumab, Pozelimab
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Regeneron Pharmaceuticals
Myelodysplastic Syndromes
Trial of Volasertib With or Without Azacitidine in Patients With Myelodysplastic Syndromes
The objectives of this trial are to evaluate the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics and preliminary efficacy of volasertib in two dosing schedules of intravenous volasertib as monotherapy or in…
- Trial name
- NCT02721875
- Testing
- Volasertib, Azacitidine
- Where
- Japan
- Volunteers
- 1 people
- Sponsor
- Boehringer Ingelheim
Myelodysplastic Syndromes
PK/Efficacy Bridging Study of ASTX727 in Chinese Subjects With Myelodysplastic Syndromes
This is an Open-Label, Crossover, Pharmacokinetic and Efficacy Bridging Study of Oral ASTX727 versus IV Decitabine in Chinese Subjects with Myelodysplastic Syndromes
- Trial name
- NCT06091267
- Testing
- IV Decitabine, Decitabine and cedazuridine, only Decitabine and cedazuridine
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Otsuka Beijing Research Institute
Myelodysplastic Syndrome
APG101 in Myelodysplastic Syndrome
It has been shown in preclinical experiments with bone marrow from patients with myelodysplastic syndrome that APG101 rescues erythrocytes from premature cell death.
- Trial name
- APG101 in MDS (NCT01736436)
- Testing
- Treatment with APG101, Bone marrow collection, Blood drawings
- Where
- 2 sites in Germany
- Volunteers
- 20 people
- Sponsor
- Apogenix GmbH
AML, MDS
A Safety and Efficacy Study of SHR-1702 Monotherapy in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
This study will assess the safety and preliminary efficacy of escalating doses of SHR-1702 monotherapy in relapsed/refractory AML and intermediate-high risk MDS
- Trial name
- NCT04443751
- Testing
- SHR-1702
- Where
- China
- Volunteers
- 31 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Myelodysplastic Syndromes, Anemia
A Study of HS-20106 to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of HS-20106 on anemia in patients with very low, low or intermediate risk MDS.
- Conditions
- Myelodysplastic Syndromes, Anemia, MDS, Bone Marrow Disease
- Trial name
- NCT06594965
- Testing
- HS-20106
- Where
- China
- Volunteers
- 176 people
- Sponsor
- Hansoh BioMedical R&D Company
Myelodysplastic Syndromes
Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS
The purpose of this study was to characterize the safety, tolerability and confirm the dose for select single agents and combinations in patients with lower risk (very low, low, and intermediate risk) MDS.
- Trial name
- NCT04810611
- Testing
- MBG453, NIS793, canakinumab
- Where
- 13 sites in United States, Australia and 5 more
- Volunteers
- 33 people
- Sponsor
- Novartis Pharmaceuticals
Paroxysmal Nocturnal Hemoglobinuria
A Long-Term Treatment Study of ACH-0144471 in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
The purpose of this study is to evaluate the long-term safety and efficacy of ACH-0144471 in participants with paroxysmal nocturnal hemoglobinuria (PNH) who have demonstrated clinical benefit from ACH-0144471 in Study ACH471-100.
- Trial name
- NCT03181633
- Testing
- ACH-0144471
- Where
- 4 sites in Italy, New Zealand and 1 more
- Volunteers
- 8 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
Study of Lonafarnib Versus Placebo in Subjects With Either Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) (Study P02978AM3)(TERMINATED)
The purpose of this study is to assess the benefit of lonafarnib (versus placebo) in patients with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML).
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Myelodysplasia, Myelomonocytic
- Trial name
- NCT00109538
- Testing
- Lonafarnib
- Volunteers
- 47 people
- Sponsor
- Merck Sharp & Dohme LLC
Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS)
Haplo-identical Natural Killer (NK) Cells to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM)
This study is a Phase II, single arm, open label multicenter trial designed to investigate the use of haploidentical donor derived NK cells (K-NK002) for the treatment of patients with high-risk acute myeloid leukemia (AML) or…
- Trial name
- NCT04395092
- Testing
- K-NK002, Conditioning Regimen, HaploBMT
- Where
- 2 sites in United States
- Sponsor
- Kiadis Pharma
Myelodysplastic Syndromes
ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions
The purpose of the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are…
- Trial name
- ELEMENT-MDS (NCT05949684)
- Testing
- Luspatercept, Epoetin Alfa
- Where
- 144 sites in United States, Argentina and 17 more
- Volunteers
- 402 people
- Sponsor
- Bristol-Myers Squibb
Myelodysplastic Syndromes
An Efficacy Study for Epoetin Alfa in Anemic Patients With Myelodysplastic Syndromes
The purpose of this study is to demonstrate that epoetin alfa works better than placebo in improving anemia in patients with lower-risk myelodysplastic syndromes (MDS). The safety of epoetin alfa will also be evaluated.
- Trial name
- NCT01381809
- Testing
- Group 1: Epoetin alfa
- Where
- 28 sites in Bulgaria, France and 3 more
- Volunteers
- 130 people
- Sponsor
- Janssen-Cilag International NV