Clinical trials: Hypomethylating Agents
MDS, Myelodysplastic Syndromes
Determination of Safe and Effective Dose of Romiplostim (AMG 531) in Subjects With Myelodysplastic Syndrome (MDS)Receiving Hypomethylating Agents
The purpose of this study is to evaluate the effect of Romiplostim (AMG 531) on the incidence of clinically significant thrombocytopenic events (grade 3 or 4 and/or receipt of platelet transfusions) in subjects with low or…
- Conditions
- MDS, Myelodysplastic Syndromes, Thrombocytopenia
- Trial name
- NCT00321711
- Testing
- AMG 531 (Romiplostim), Azacitidine, Decitabine
- Volunteers
- 69 people
- Sponsor
- Amgen
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
Myelodysplastic Syndrome
Phase 1 Study to Evaluate MEDI4736 in Subjects With Myelodysplastic Syndrome
This is a multicenter, open-label, Phase 1 study to assess the safety and antitumor activity of MEDI4736 as Monotherapy or in Combination with Tremelimumab with or without Azacitidine in Subjects with myelodysplastic syndrome…
- Trial name
- NCT02117219
- Testing
- MEDI4736 Evaluate MEDI4736 in MDS, VIDAZA, tremelimumab
- Where
- 21 sites in United States, France and 2 more
- Volunteers
- 67 people
- Sponsor
- MedImmune LLC
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
Myelodysplastic Syndrome, Myelodysplastic Syndromes
Safety, Clinical Activity, Pharmacokinetics (PK) and Pharmacodynamics Study of GSK2879552, Alone or With Azacitidine, in Subjects With High Risk Myelodysplastic Syndromes (MDS)
This is a Phase I/II, open-label, 2 arm study to evaluate the safety and clinical activity of GSK2879552 alone, or in combination with azacitidine in subjects with MDS. The study consisted of 2 parts.
- Trial name
- NCT02929498
- Testing
- GSK2879552, Azacitidine
- Where
- 6 sites in United States, Spain
- Volunteers
- 7 people
- Sponsor
- GlaxoSmithKline
Acute Myeloid Leukemia, Myelodysplastic Syndrome
A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With AML or MDS
This is the first study of the safety of increasing dose levels of AEB1102 in patients with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome.
- Trial name
- NCT02732184
- Testing
- Co-ArgI-PEG modified human arginase I
- Where
- 10 sites in United States, Canada
- Volunteers
- 21 people
- Sponsor
- Immedica Pharma AB
Myelodysplastic Syndromes
A Safety and Efficacy Study of Pracinostat and Azacitidine in Patients With High Risk Myelodysplastic Syndromes
This is a Phase 2, two-stage study of the safety and efficacy of pracinostat in combination with azacitidine in patients with IPSS-R high and very high risk myelodysplastic syndrome (MDS) who are previously untreated with…
- Trial name
- NCT03151304
- Testing
- Pracinostat, Azacitidine
- Where
- 25 sites in United States
- Volunteers
- 64 people
- Sponsor
- Helsinn Healthcare SA
Myelodysplastic Syndromes (MDS)
A Phase 1b/2 Study of Alvocidib Plus Decitabine or Azacitidine in Patients With MDS
Alvocidib, a cyclin-dependent kinase 9 (CDK 9) inhibitor, in time-sequential therapy demonstrated significant clinical activity in secondary AML patients with prior MDS.
- Trial name
- NCT03593915
- Testing
- Alvocidib Plus Decitabine (during dose escalation only) or Azacitidine
- Where
- 12 sites in United States
- Volunteers
- 20 people
- Sponsor
- Sumitomo Pharma America, Inc.
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
A Study of MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS).
This Phase II was a multicenter, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to hypomethylating agents (azacitidine or decitabine) in adult subjects with IPSS-R…
- Trial name
- STIMULUS-MDS1 (NCT03946670)
- Testing
- MBG453, Hypomethylating agents
- Where
- 48 sites in United States, Austria and 15 more
- Volunteers
- 127 people
- Sponsor
- Novartis Pharmaceuticals
Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
Safety and Effectiveness Study of CPI-613 to Treat Refractory or Relapsed Leukemia and Myelodysplastic Syndrome
The purpose of this study is to determine whether CPI-613 is effective and safe in either patients with refractory or relapsed acute myeloid leukemia (AML) or patients with myelodysplastic syndrome (MDS) who have failed therapy…
- Trial name
- NCT01520805
- Testing
- CPI-613
- Where
- United States
- Sponsor
- Cornerstone Pharmaceuticals
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs
A Phase 3, randomized, open-label, parallel-group, multicenter study designed to evaluate the efficacy and safety of guadecitabine in participants with MDS or CMML who failed or relapsed after adequate prior treatment with…
- Trial name
- NCT02907359
- Testing
- Guadecitabine, Treatment Choice
- Where
- 112 sites in United States, Belgium and 12 more
- Volunteers
- 417 people
- Sponsor
- Astex Pharmaceuticals, Inc.