Clinical trials: High-Risk Acute Myeloid Leukemia
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
AML, MDS
Study of APVO436 in Patients With AML or MDS
The primary objective of the Phase 1 part of the study is to determine the recommended dose of APVO436 administered intravenously to patients with AML or MDS.
- Trial name
- NCT03647800
- Testing
- APVO436
- Where
- 12 sites in United States
- Volunteers
- 136 people
- Sponsor
- Aptevo Research and Development LLC
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
A Study of ARGX-110 in Combination With Azacytidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) or High Risk Myelodysplatic Syndrome (MDS)
The purpose of this study is to determine the maximum tolerated dose (MTD) of ARGX-110 and/or the recommended Phase II dose (RP2D) in combination with a standard dose of azacytidine (AZA) in Phase 1; and to evaluate efficacy of…
- Trial name
- NCT03030612
- Testing
- ARGX-110, AZA
- Where
- 7 sites in France, Switzerland
- Volunteers
- 38 people
- Sponsor
- OncoVerity, 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.
Leukemia, Leukemia, Myeloid
A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome
Study BH-30236-01 is a first-in-human (FIH), Phase 1/1b, open-label, dose escalation and expansion study in participants with relapsed/refractory acute myelogenous leukemia (R/R AML) or higher-risk myelodysplastic syndrome…
- Conditions
- Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Preleukemia
- Trial name
- NCT06501196
- Testing
- BH-30236, Venetoclax
- Where
- 13 sites in United States
- Volunteers
- 170 people
- Sponsor
- BlossomHill Therapeutics
Leukemia, Myeloid, Acute
Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd/4th Salvage
Phase III, multicenter, randomized study with two arms (1:1 ratio) enrolling patients with AML relapsed/refractory after 2, 3, or 4 prior induction regimens: Experimental arm: DFP-10917 14-day continuous intravenous (IV) infusion…
- Trial name
- NCT03926624
- Testing
- DFP-10917, Cytarabine, Azacitidine
- Where
- 39 sites in United States
- Volunteers
- 167 people
- Sponsor
- Delta-Fly Pharma, Inc.
Leukaemia
First in Human Testing of Dose-escalation of SAR440234 in Patients With Acute Myeloid Leukemia, Acute Lymphoid Leukemia and Myelodysplastic Syndrome
Primary Objective: Dose escalation: To determine the maximum tolerated dose (MTD) of SAR440234 administered as a single agent in participants with relapsed or refractory acute myeloid leukemia (R/R AML), high risk myelodysplastic…
- Trial name
- NCT03594955
- Testing
- SAR440234
- Where
- 4 sites in United States, France
- Volunteers
- 7 people
- Sponsor
- Sanofi
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
Hematologic Malignancy, Acute Myeloid Leukemia
CD123-CD33 cCAR in Patients With Relapsed and/or Refractory, High Risk Hematologic Malignancies
Phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD123-CD33 cCAR in patients with relapsed and/or refractory, high risk hematologic malignancies.
- Conditions
- Hematologic Malignancy, Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myeloproliferative Neoplasm
- Trial name
- NCT04156256
- Testing
- CD123-CD33 cCAR T cells
- Where
- 2 sites in China
- Volunteers
- 20 people
- Sponsor
- iCell Gene Therapeutics
Acute Myeloid Leukemia, Myelodysplastic Syndromes
PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome (CPKC412A2104 Core); and PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome With Either Wild Type or Mutated FMS-like Tyrosine Kinase 3 (FLT3) (CPKC412A2104E1 and CPKC412A2104E2)
CPKC412A2104 core had a 2 stage design. In stage 1, eight participants were treated. If at least one participant showed a clinical response, four more participants were recruited to stage 2.
- Trial name
- NCT00045942
- Testing
- Itraconazole, PKC412
- Where
- 4 sites in United States
- Volunteers
- 144 people
- Sponsor
- Novartis Pharmaceuticals
Acute Promyelocytic Leukemia (APL), Acute Promyelocytic Leukaemia
A Trial to Investigate Whether Oral Arsenic Trioxide Is Similar to Intravenous Arsenic Trioxide in Pharmacokinetics, Safety, and Efficacy (LATITUDE/SDKARS-301)
LATITUDE: A Phase 3, Randomized, Open-Label, 3-Cohort, 2-Period, 2- Sequence, Crossover Trial to Evaluate the Pharmacokinetics, Safety, and Efficacy of Oral Arsenic Trioxide Versus Intravenous Arsenic Trioxide for Consolidation…
- Conditions
- Acute Promyelocytic Leukemia (APL), Acute Promyelocytic Leukaemia, Acute Promyelocytic Leukemia With PML-RARA, Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA
- Trial name
- LATITUDE (NCT07296445)
- Testing
- Oral ATO, IV Arsenic Trioxide, all-trans retinoic acid (ATRA)
- Volunteers
- 120 people
- Sponsor
- SDK Therapeutics, Inc.
High Risk Acute Myeloid Leukemia
Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia
To confirm the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients (60-75 yrs) with high risk (secondary) Acute Myeloid Leukemia. The primary efficacy endpoint will be overall survival.
- Trial name
- 301 (NCT01696084)
- Testing
- CPX-351, 7+3 (cytarabine and daunorubicin)
- Where
- 43 sites in United States, Canada
- Volunteers
- 309 people
- Sponsor
- Jazz Pharmaceuticals
Myelodysplastic Syndrome, Acute Myelogenous Leukemia
A Phase I/II Study of MGCD0103 With Azacitidine in Patients With High-Risk Myelodysplastic Syndrome (MDS) or Acute Myelogenous Leukemia
In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly in combination with azacitidine to patients with high-risk myelodysplastic syndromes or acute myelogenous leukemia.
- Trial name
- NCT00324220
- Testing
- MGCD0103
- Where
- 8 sites in United States
- Volunteers
- 66 people
- Sponsor
- Mirati Therapeutics Inc.
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
Secondary AML, Myelofibrosis
A Study of Rebecsinib for Patients With Relapsed/Refractory Secondary Acute Myeloid Leukemia or High Risk Myelofibrosis
The purpose of this study is to test the safest and most effective dose of a new investigational drug, rebecsinib. Participants in this study will have either Secondary Acute Myeloid Leukemia (sAML) that has either returned…
- Trial name
- NCT07250646
- Testing
- rebecsinib
- Where
- 3 sites in United States
- Volunteers
- 28 people
- Sponsor
- Aspera Biomedicines, Inc.
Relapsed and/or Refractory Acute Myeloid Leukemia, High Risk Hematologic Malignancies
Anti-CD33 CAR-T Cells for the Treatment of Relapsed/Refractory CD33+ Acute Myeloid Leukemia
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of anti-CD33 CAR-T cells in patients with relapsed and/or refractory, high risk hematologic malignancies.
- Trial name
- NCT05445765
- Testing
- anti-CD33 CAR T cells
- Where
- China
- Volunteers
- 10 people
- Sponsor
- iCell Gene Therapeutics
Myelodysplastic Syndromes, Acute Myeloid Leukemia
A Study of Sabatolimab and Magrolimab-based Treatment in AML or Higher Risk MDS Participants
This study is to determine the safety and preliminary efficacy of sabatolimab in combination with magrolimab and azacitidine in adult participants with 1L unfit Acute Myeloid Leukemia (AML) or with 1L higher risk Myelodysplastic…
- Trial name
- NCT05367401
- Testing
- Sabatolimab, Magrolimab, Azacitidine
- Sponsor
- Novartis Pharmaceuticals
Acute Myeloid Leukemia, Myelodysplastic Syndrome
A Study of Bomedemstat (IMG-7289/MK-3543) With and Without ATRA, in Participants With Advanced Myeloid Malignancies (IMG-7289-CTP-101/MK-3543-001)
This is an open label study of the dose and duration of an orally administered lysine-specific demethylase 1 (LSD1) inhibitor, bomedemstat, in patients with high-risk acute myeloid leukemia (AML) and high-risk myelodysplastic…
- Trial name
- NCT02842827
- Testing
- bomedemstat, tretinoin
- Where
- Australia
- Volunteers
- 45 people
- Sponsor
- Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
Treatment of Elderly Patients With Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic (MD) Syndrome With Laromustine and Infusional Cytarabine
The purpose of the Phase I portion of this study is to evaluate the safety of this combination of medications and to determine the appropriate dose of VNP40101M to be used in combination with infusional cytarabine (araC) in…
- Trial name
- NCT00655395
- Testing
- Laromustine (VNP40101M) and Ara-C
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Viron Therapeutics Inc
Acute Myelogenous Leukemia, Myelodysplastic Syndrome
Safety, Tolerability and Pharmacokinetics of Milademetan Alone and With 5-Azacitidine (AZA) in Acute Myelogenous Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
This study will take place in parts: Dose Escalation (Part 1): Participants receive milademetan alone with different dose schedules Dose Escalation (Part 1A): Participants receive milademetan in combination with 5-azacytidine…
- Trial name
- NCT02319369
- Testing
- Milademetan, AZA
- Where
- 5 sites in United States
- Volunteers
- 74 people
- Sponsor
- Daiichi Sankyo