Clinical trials: Higher-risk Myelodysplastic Syndromes
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 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
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
A Study of Cusatuzumab Plus Azacitidine in Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome Who Are Not Candidates for Intensive Treatment
The purpose of this study is to determine the recommended Phase 2 dose and evaluate safety profile of cusatuzumab in combination with azacitidine in Japanese participants with treatment naïve acute myeloid leukemia (AML) who are…
- Trial name
- NCT04241549
- Testing
- Cusatuzumab, Azacitidine
- Where
- 5 sites in Japan
- Volunteers
- 6 people
- Sponsor
- OncoVerity, Inc.
Myelodysplastic Syndrome
A Trial of AK117 (Anti-CD47) in Patients With Myelodysplastic Syndrome
This is a open label, phase I/II study. All patients are diagnosed with higher-risk MDS, Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Trial name
- NCT04900350
- Testing
- AK117, Azacitidine
- Where
- China
- Volunteers
- 136 people
- Sponsor
- Akeso
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 Syndromes (MDS)
A Study of Pevonedistat Combined With Decitabine and Cedazuridine in Adults With Higher-risk Myelodysplastic Syndromes
The main aim of the study is to see if signs and symptoms of myelodysplastic syndromes disappear when treated with pevonedistat combined with decitabine and cedazuridine.
- Trial name
- PEVOBINE (NCT04985656)
- Testing
- Pevonedistat, Decitabine, Cedazuridine
- Sponsor
- Takeda
Acute Myeloid Leukemia
A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
This is a study to evaluate PF-04449913 (an inhibitor of the Hedgehog pathway) in Acute Myeloid Leukemia and high-risk Myelodysplastic Syndrome in combination with standard agents used to treat these diseases.
- Trial name
- NCT01546038
- Testing
- PF-04449913, Low dose ARA-C (LDAC), Decitabine
- Where
- 81 sites in United States, Canada and 4 more
- Volunteers
- 255 people
- Sponsor
- Pfizer
Relapsed or Refractory Haematological Malignancies Including, Acute Myeloid Leukemia
Study to Assess Safety, Tolerability, Pharmacokinetics and Antitumor Activity of AZD4573 in Relapsed/Refractory Haematological Malignancies
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary antitumor activity of AZD4573 in subjects with relapsed or refractory haematological malignancies.
- Conditions
- Relapsed or Refractory Haematological Malignancies Including, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Chronic Lymphocytic Leukemia
- Trial name
- NCT03263637
- Testing
- AZD4573
- Where
- 12 sites in Germany, Netherlands and 1 more
- Volunteers
- 44 people
- Sponsor
- AstraZeneca
Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML)
Pharmacokinetics, Tolerability and Safety of NEX-18a
The study will evaluate the safety, tolerability and pharmacokinetics of NEX-18a, a long-acting injectable azacitidine, in patients diagnosed with intermediate 2 or higher-risk MDS, CMML, or AML and already on treatment with…
- Conditions
- Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), Acute Myeloid Leukemia (AML)
- Trial name
- NCT05048498
- Testing
- NEX-18a injection, Azacitidine Injection
- Where
- 2 sites in Sweden
- Volunteers
- 2 people
- Sponsor
- Nanexa AB
Myelodysplastic Syndromes
Expanded Access Program With Pevonedistat (Given With Azacitidine) for Adults With Higher-risk Myelodysplastic Syndromes
Participants in the expanded access program are adults with higher-risk myelodysplastic syndromes who have no other treatment options available.
- Trial name
- NCT04484363
- Testing
- Pevonedistat, Azacitidine
- Sponsor
- Takeda
AML, Acute Myeloid Leukemia
A Study of APG-115 Alone or Combined With Azacitidine in Patients With AML, CMML, or MDS
This is a two Part study in patients with relapsed/refractory acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), or high risk myelodysplastic syndrome (MDS) that will initially evaluate the safety and…
- Conditions
- AML, Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, CMML
- Trial name
- NCT04358393
- Testing
- APG-115, 5-azacitidine
- Where
- 8 sites in United States
- Volunteers
- 69 people
- Sponsor
- Ascentage Pharma Group 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
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