Clinical trials: High-Risk Acute Myeloid Leukemia
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
Fungal Infection, Acute Myelogenous Leukemia
Oral Posaconazole in High Risk Patients With Gastrointestinal Dysfunction (Study P05115)
The purpose of this study is: to explore the potential for different dosing strategies of posaconazole oral suspension (POS) to increase plasma levels and to profile the pharmacokinetics of these dosing strategies in patients…
- Conditions
- Fungal Infection, Acute Myelogenous Leukemia, Neutropenia
- Trial name
- NCT00686543
- Testing
- Posaconazole
- Volunteers
- 75 people
- Sponsor
- Merck Sharp & Dohme LLC
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
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
AML, Adult Recurrent, MDS
Safety and Efficacy of Allogeneic NK Cell Infusions in Patients With Relapsed/Refractory AML and High Risk MDS
This study involves the use of an investigational cell therapy known as DVX201. DVX201 is an investigational cell therapy that contains a type of white blood cell called natural killer (NK) cells.
- Trial name
- NCT04901416
- Testing
- DVX201
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Coeptis Therapeutics
High-risk Myelodysplastic Syndromes, Acute Myelogenous Leukemia
GTB-3550 Tri-Specific Killer Engager (TriKE®) for High Risk Hematological Malignancies
This is a multi-center Phase I/II clinical trial of GTB-3550 (CD16/IL-15/CD33) tri-specific killer cell engager (TriKE®) for the treatment of CD33-expressing high risk myelodysplastic syndromes, refractory/relapsed acute myeloid…
- Conditions
- High-risk Myelodysplastic Syndromes, Acute Myelogenous Leukemia, Systemic Mastocytosis, Mast Cell Leukemia
- Trial name
- NCT03214666
- Testing
- GTB-3550 TriKE® Phase I, GTB-3550 TriKE® Phase II
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- GT Biopharma, Inc.
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
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, 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
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.
Hematologic Malignancies
Safety Study of Gene Modified Donor T-Cells in Adults With Advanced Hematologic Malignancies
This is an open-label, non-randomized study to evaluate the safety of two planned infusions of BPX-501 T cells after partially mismatched, related (haploidentical) HSCT in adults with hematologic malignancies.
- Trial name
- NCT02487459
- Testing
- BPX-501, AP1903
- Where
- United States
- Sponsor
- Bellicum Pharmaceuticals
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
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
Leukemia, Myeloid, Acute
BI 836858 Dose Escalation in Patients With Refractory or Relapsed Acute Myeloid Leukemia and in Patients With AML in Complete Remission With High Risk to Relapse
Patients with acute myeloid leukemia who experience a relapse after at least one prior regimen may be enrolled in this trial. In addition, acute myeloid leukemia patients who are in complete remission with high risk to relapse…
- Trial name
- NCT01690624
- Testing
- BI 836858
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Boehringer Ingelheim
Acute Myeloid Leukemia, B-cell Acute Lymphoblastic Leukemia
Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies
Dose Escalation - Determine the maximum tolerated dose (MTD), if possible, or minimum optimal biologic dose (OBD), and evaluate the safety and tolerability of VIP943 in subjects with advanced CD123+ hematologic malignancies
- Conditions
- Acute Myeloid Leukemia, B-cell Acute Lymphoblastic Leukemia, High-risk Myelodysplastic Syndrome
- Trial name
- NCT06034275
- Testing
- VIP943 (QW), VIP943 (BIW)
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- Vincerx Pharma, Inc.
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
Myelodysplastic Syndromes, Myelogenous Leukemia, Acute
A Study of Vismodegib in Patients With Relapsed/Refractory Acute Myelogenous Leukemia and Relapsed Refractory High-Risk Myelodysplastic Syndrome
This study will assess the safety and efficacy of vismodegib in patients with relapsed/refractory acute myelogenous leukemia (AML) and relapsed/refractory high-risk myelodysplastic syndrome (MDS).
- Trial name
- NCT01880437
- Testing
- cytarabine, vismodegib
- Where
- 14 sites in United States, Canada and 1 more
- Volunteers
- 38 people
- Sponsor
- Hoffmann-La Roche
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
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
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