Clinical trials: High-Risk Acute Myeloid Leukemia
Acute Myeloid Leukemia
A Study of Midostaurin Efficacy and Safety in Newly Diagnosed Patients With FLT3-mutated AML
This study evaluated the efficacy and safety of midostaurin in combination with daunorubicin/cytarabine induction, high dose cytarabine consolidation and midostaurin single agent continuation therapy in newly diagnosed patients…
- Trial name
- NCT03280030
- Testing
- Midostaurin
- Where
- 34 sites in Hong Kong, Japan and 4 more
- Volunteers
- 67 people
- Sponsor
- Novartis Pharmaceuticals
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
Adenocarcinoma, Adenocystic Carcinoma
The Registry of Oncology Outcomes Associated With Testing and Treatment
This study is to collect and validate regulatory-grade real-world data (RWD) in oncology using the novel, Master Observational Trial construct. This data can be then used in real-world evidence (RWE) generation.
- Conditions
- Adenocarcinoma, Adenocystic Carcinoma, Anal Cancer, Appendix Cancer
- Trial name
- ROOT (NCT04028479)
- Testing
- Biomarker Testing (L), Systemic Treatment (T), Patient Reported Outcomes (P)
- Where
- 2 sites in United States
- Volunteers
- 167 people
- Sponsor
- Taproot Health
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.
AML and High Risk MDS
A Safety and Efficacy Study of LGH447 in Patients With Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)
This study will assess the safety and preliminary efficacy of escalating doses of LGH447 monotherapy in AML and MDS and LGH447 in combination with midostaurin in AML.
- Trial name
- NCT02078609
- Testing
- LGH447, LGH447 + midostaurin
- Where
- 9 sites in United States, Australia and 5 more
- Volunteers
- 70 people
- Sponsor
- Novartis Pharmaceuticals
Acute Myeloid Leukemia, Myelodysplastic Syndrome
A Study of BTX-A51 in People With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
This is an open-label, dose escalation study to evaluate the safety, toxicity, and pharmacokinetics (PK) as well as preliminary efficacy of BTX-A51 capsules in participants with relapsed or refractory acute myeloid leukemia (AML)…
- Trial name
- NCT04243785
- Testing
- BTX-A51, Azacitidine
- Where
- 3 sites in United States
- Volunteers
- 80 people
- Sponsor
- Edgewood Oncology Inc.
Acute Myeloid Leukemia (AML)
Safety, Tolerability and Pharmacokinetics of CSL360 in the Treatment of Acute Myeloid Leukemia
Acute myeloid leukemia (AML) is a heterogeneous group of diseases characterized by uncontrolled proliferation of the myeloid line of white blood cells and impaired production of normal blood cells.
- Trial name
- NCT00401739
- Testing
- CSL360
- Where
- 6 sites in Australia
- Volunteers
- 40 people
- Sponsor
- CSL Limited
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
R/R AML, R/R HR-MDS
First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelodysplastic Syndrome (HR-MDS)
The drug that will be investigated in the trial is an antibody, GEN3018. Since this is the first trial of GEN3018 in humans, the main purpose is to evaluate safety.
- Conditions
- R/R AML, R/R HR-MDS, Acute Myeloid Leukemia, Higher-Risk Myelodysplastic Syndrome
- Trial name
- NCT07384715
- Testing
- GEN3018
- Where
- 9 sites in Denmark, Italy and 1 more
- Volunteers
- 78 people
- Sponsor
- Genmab
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
Acute Myeloid Leukemia (AML)
PKC412, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
RATIONALE: PKC412 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It may also increase the effectiveness of daunorubicin and cytarabine by making cancer cells more sensitive to the drugs.
- Trial name
- NCT00093600
- Testing
- cytarabine, daunorubicin hydrochloride, midostaurin
- Where
- 6 sites in United States, Germany
- Volunteers
- 69 people
- Sponsor
- Novartis Pharmaceuticals
Leukemia, Myeloid, Acute
A Study of CSL362 in Patients With CD123+ Acute Myeloid Leukemia Currently in Remission
This is a first in human, prospective, multicenter, nonrandomized, open-label, dose-escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of repeat doses of CSL362.
- Trial name
- NCT01632852
- Testing
- CSL362
- Where
- 5 sites in United States, Australia
- Volunteers
- 30 people
- Sponsor
- CSL Limited
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 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
Acute Myelogenous Leukemia, High-Grade Myelodysplastic Syndrome
A Phase 2 Trial of MLN8237 in Adult Participants With Acute Myelogenous Leukemia and High-Grade Myelodysplastic Syndrome
This is an open-label, multicenter, phase 2 study of alisertib (MLN8237) in participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
- Trial name
- NCT00830518
- Testing
- Alisertib
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
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
Acute Myeloid Leukemia, Myelodysplastic Syndrome
Safety and Proof-of-Concept Study of RPT1G in Adults With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes
The main goals of this study are to learn if RPT1G is safe and tolerable and to determine the best dose and schedule of RPT1G for patients with relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic…
- Trial name
- NCT07107126
- Testing
- RPT1G
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Remedy Plan, Inc.
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
A Study of CC-90002 in Subjects With Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (MDS)
Study CC-90002-AML-001 is an open-label, Phase 1 dose escalation (Part A) and expansion (Part B), clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects with relapsed and/or primary refractory AML and…
- Trial name
- NCT02641002
- Testing
- CC-90002
- Where
- 6 sites in United States
- Volunteers
- 28 people
- Sponsor
- Celgene
Acute Myeloid Leukemia (AML), High-risk Myelodysplastic Syndrome (MDS)
HDM201 in Combination With MBG453 or Venetoclax in Patients With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS)
This was a phase 1b, multi-arm, open-label study of HDM201 in combination with MBG453 or venetoclax in subjects with AML or high-risk MDS.
- Trial name
- NCT03940352
- Testing
- HDM201, MBG453, Venetoclax
- Where
- 9 sites in United States, Australia and 5 more
- Volunteers
- 52 people
- Sponsor
- Novartis Pharmaceuticals
Myelodysplastic Syndromes (MDS)
A Study Evaluating Venetoclax in Combination With Azacitidine in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)
This is a Phase 1b, open-label, non-randomized, multicenter, dose-finding study evaluating venetoclax in combination with azacitidine in participants with treatment-naïve higher-risk MDS comprising a dose-escalation portion and a…
- Trial name
- NCT02942290
- Testing
- Azacitidine, Venetoclax
- Where
- 37 sites in United States, Australia and 5 more
- Volunteers
- 134 people
- Sponsor
- AbbVie