Clinical trials: High Risk Chronic Myelomonocytic Leukemia
AML, Adult
A Study of APG-2575 in Combination With Azacitidine in Patients With Acute Myeloid Leukemia (AML)
This is a Phase Ib/II, open-label, multi-center study evaluating the safety, tolerability, efficacy and PK of APG-2575 in combination with Azacitidine in the patients with AML/MPAL or MDS/CMML.
- Trial name
- NCT04964518
- Testing
- APG 2575 ramp up arm
- Where
- 9 sites in United States, Australia
- Volunteers
- 24 people
- Sponsor
- Ascentage Pharma Group Inc.
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, Leukemia, Myelomonocytic, Chronic
A Study of Pevonedistat in People With Blood Cancers or Solid Tumors With Kidney or Liver Problems
Pevonedistat is a medicine to treat people with blood cancers or solid tumors. The main aim of the study is to learn about the levels of pevonedistat in the blood of participants with blood cancers or solid tumors, who also have…
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute, Renal Insufficiency
- Trial name
- NCT03814005
- Testing
- Azacitidine, Pevonedistat
- Where
- 8 sites in United States, Spain
- Volunteers
- 17 people
- Sponsor
- Takeda
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
Myelodysplastic Syndrome, Leukemia, Myelomonocytic, Chronic
Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML)
The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves event-free survival (EFS) when compared with single-agent azacitidine.
- Conditions
- Myelodysplastic Syndrome, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
- Trial name
- PANTHER (NCT03268954)
- Testing
- Azacitidine, Pevonedistat
- Where
- 242 sites in United States, Australia and 18 more
- Volunteers
- 454 people
- Sponsor
- Takeda
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
Myelodysplastic Syndrome (MDS)
A Study of BLEX 404 Oral Liquid in Patients With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-Risk Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML)
This is a clinical trial to determine the safety, recommended dose level (RDL), and infection control of BLEX 404 Oral Liquid in combination with azacitidine in patients with International Prognostic Scoring System (IPSS)…
- Trial name
- NCT02944955
- Testing
- BLEX 404 Oral Liquid
- Volunteers
- 52 people
- Sponsor
- BioLite, Inc.
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
Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia (CMML)
SNS-301 Monotherapy in High Risk MDS and CMML
To evaluate safety, immunogenicity and anti-tumor responses of intradermally delivered SNS-301 in patients with ASPH+ high risk MDS and CMML.
- Trial name
- NCT04217720
- Testing
- SNS-301
- Sponsor
- Sensei Biotherapeutics, Inc.
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
An Efficacy and Safety Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) and Low-Blast Acute Myelogenous Leukemia (AML)
The purpose of this study is to evaluate the efficacy and safety of pevonedistat plus azacitidine versus single-agent azacitidine in participants with HR-MDS or CMML, or low-blast AML.
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
- Trial name
- NCT02610777
- Testing
- Azacitidine, Pevonedistat
- Where
- 59 sites in United States, Belgium and 10 more
- Volunteers
- 120 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
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 Syndromes, Leukemia, Myelomonocytic, Chronic
Volasertib in Combination With Azacitidine in Japanese Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
To identify the maximum tolerated dose or recommended dose for further development of volasertib in combination with azacitidine in Japanese patients with myelodysplastic syndromes or chronic myelomonocytic leukemia, and evaluate…
- Trial name
- NCT02201329
- Testing
- Azacitidine, Volasertib
- Where
- 4 sites in Japan
- Volunteers
- 5 people
- Sponsor
- Boehringer Ingelheim
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
MDS, AML
Non-interventional Study With Azacitidin (Vidaza®)
The purpose of this non-interventional study is to collect data on the efficiency and safety of Azacitidin in the routine application.
- Conditions
- MDS, AML, CMMOL
- Trial name
- Piaza (NCT01192945)
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- iOMEDICO AG
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.
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)
This was a Phase III multi-center, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to azacitidine in adult participants with intermediate, high or very high-risk…
- Trial name
- STIMULUS-MDS2 (NCT04266301)
- Testing
- Sabatolimab, Azacitidine
- Where
- 149 sites in United States, Argentina and 34 more
- Volunteers
- 530 people
- Sponsor
- Novartis Pharmaceuticals
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
Advanced Systemic Mastocytosis (AdvSM), SM With an Associated Hematologic Neoplasm (SM-AHN)
(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis
This is an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm…
- Conditions
- Advanced Systemic Mastocytosis (AdvSM), SM With an Associated Hematologic Neoplasm (SM-AHN), Mast Cell Leukemia (MCL), Aggressive Systemic Mastocytosis (ASM)
- Trial name
- NCT04996875
- Testing
- bezuclastinib
- Where
- 42 sites in United States, Australia and 12 more
- Volunteers
- 140 people
- Sponsor
- Cogent Biosciences, Inc.
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
Phase I Dose Escalation Trial of Volasertib in Combination With Azacitidine in Patients With MDS or CMML
To investigate the maximum tolerated dose (MTD), safety, pharmacokinetics, and efficacy of volasertib in combination with azacitidine in patients with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) and…
- Trial name
- NCT01957644
- Testing
- Azacitidine, Volasertib
- Where
- 14 sites in France, Germany
- Volunteers
- 16 people
- Sponsor
- Boehringer Ingelheim
Leukemia, Leukemia, Myeloid
Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS
To characterize the safety and tolerability of 1) MBG453 as a single agent or in combination with PDR001 or 2) PDR001 and/or MBG453 in combination with decitabine or azacitidine in AML and intermediate or high- risk MDS patients…
- Conditions
- Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
- Trial name
- NCT03066648
- Testing
- Decitabine, PDR001, MBG453
- Where
- 11 sites in United States, Australia and 6 more
- Volunteers
- 241 people
- Sponsor
- Novartis Pharmaceuticals