Clinical trials: Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)
- Condition Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)
- Funder type Industry (pharma, biotech, devices)
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory
Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)
Iadademstat is being studied as a treatment for subjects with Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) with FMS-like tyrosine kinase mutation (FLT3 mut+).
- Trial name
- FRIDA (NCT05546580)
- Testing
- Iadademstat, Gilteritinib Oral Tablet
- Where
- 13 sites in United States
- Volunteers
- 50 people
- Sponsor
- Oryzon Genomics S.A.
Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)
A Study of BL-M11D1 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Ia: To observe the safety and tolerability of BL-M11D1 in patients with relapsed/refractory acute myeloid leukemia to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of BL-M11D1.
- Trial name
- NCT05924750
- Testing
- BL-M11D1
- Where
- 8 sites in China
- Volunteers
- 130 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Acute Myeloid Leukemia (AML)
Induced Pluripotent Stem Cells Derived Natural Killer Cells Therapy for Refractory and Relaps Acute Myelogenous Leukemia
This is a clinical study on the use of iNK cells for the treatment of refractory relapsed acute myeloid leukemia.
- Trial name
- iNK-r/r AML (NCT06702098)
- Testing
- iNK cells
- Where
- China
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Guangzhou Ruixin Biotechnological Co., LTD
AML
(QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive
The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication…
- Trial name
- NCT02039726
- Testing
- Quizartinib, Salvage Chemotherapy
- Where
- 131 sites in United States, Australia and 17 more
- Volunteers
- 367 people
- Sponsor
- Daiichi Sankyo
Leukemia, Myeloid, Acute
HDM201 Added to CT in R/R or Newly Diagnosed AML
This is a multi-center open-label Phase I/II study investigating orally administered HDM201 in combination with chemotherapy in two populations: subjects with first line AML or subjects with relapsed/refractory AML.
- Trial name
- NCT03760445
- Testing
- HDM201, cytarabine, anthracycline
- Sponsor
- Novartis Pharmaceuticals
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory
Clinical Study of ARD103 CAR-T Therapy for Patients With R/R AML or MDS
This is a phase I/2, interventional, open-label, multicenter study to assess the safety and efficacy of ARD103 in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.
- Conditions
- Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory, MDS (Myelodysplastic Syndrome)
- Trial name
- NCT06680752
- Testing
- ARD103, Cyclophosphamide, Fludarabine
- Where
- 3 sites in United States
- Volunteers
- 49 people
- Sponsor
- ARCE Therapeutics, Inc.
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory
Phase 1 Study of Allo-RevCAR01-T-CD123 in Patients With Selected CD123 Positive Hematologic Malignancies (1b Dose Expansion)
The Allo-RevCAR01-T-CD123 drug is a combination of a cellular component (Allo-RevCAR01-T) with a recombinant antibody derivative (R-TM123), which together form the active drug.
- Trial name
- RevSTAR-123 (NCT05949125)
- Testing
- Cyclophosphamide (Non-IMP, Lymphodepletion), Fludarabine (Non-IMP, Lymphodepletion), R-TM123
- Where
- 15 sites in Germany, Netherlands
- Volunteers
- 37 people
- Sponsor
- AvenCell Europe GmbH
Acute Myeloid Leukemia
A Study to Evaluate HMPL-306 in Patients With IDH1or IDH2-mutated Acute Myeloid Leukemia
This study is a multicenter, randomized, open-label, phase III clinical study (RAPHAEL) to evaluate the efficacy, safety, and PK of HMPL-306 versus salvage chemotherapy in patients with R/R AML harboring IDH1 and IDH2 mutations.
- Trial name
- NCT06387069
- Testing
- HMPL-306 Regimen, Salvage Chemotherapy Regimen
- Where
- 53 sites in China
- Volunteers
- 316 people
- Sponsor
- Hutchmed
Relapsed Adult AML
Study of Oral PCLX-001 in R/R Acute Myeloid Leukemia
This is a dose-finding study of oral zelenirstat (PCLX-001) in patients with R/R AML. There are two parts to the study: Dose Escalation and Dose Expansion.
- Trial name
- NCT06613217
- Testing
- zelenirstat
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Pacylex Pharmaceuticals
Leukemia, Acute Myeloid Leukemia
A Phase 1 Dose Escalation and Expanded Cohort Study of EPZ-5676 in the Treatment of Pediatric Patients With Relapsed/Refractory Leukemias Bearing a Rearrangement of the MLL Gene
A subset of patients with acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) harbor rearrangements of the MLL gene, which are detected either by cytogenetic or fluorescent in situ hybridization evaluation at the…
- Conditions
- Leukemia, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Acute Leukemias
- Trial name
- NCT02141828
- Testing
- EPZ-5676
- Where
- 9 sites in United States, Canada
- Volunteers
- 18 people
- Sponsor
- Epizyme, Inc.
Acute Myeloid Leukemia, Lymphoid Leukemia
Oshadi D & Oshadi R Combined With Salvage Chemotherapy for Relapsed Acute Myeloid Leukemia or Lymphoid Leukemia Patients
The study will be a prospective open-label single-center study in previously treated patients with Acute Myeloid Leukemia (AML) or Acute Lymphoid Leukemia (ALL).
- Trial name
- NCT02462265
- Testing
- Oshadi D & Oshadi R;, salvage therapy cytosar and mitoxantrone
- Volunteers
- 15 people
- Sponsor
- Oshadi Drug Administration
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
The primary purpose of this study is to characterize the pharmacokinetic (PK) parameters of revumenib and its major metabolite, N-deethyl revumenib (M1) after a single dose of revumenib in participants with severe liver or kidney…
- Conditions
- Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia, Refractory Leukemia, Relapsed Leukemia
- Trial name
- NCT07923071
- Testing
- Revumenib
- Volunteers
- 18 people
- Sponsor
- Syndax Pharmaceuticals
Acute Myeloid Leukemia
A Study of TAS1440 With ATRA in Subjects With r/r AML
This is a multicenter, 2-part, Phase 1 study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of TAS1440 administered as a single agent and in combination with all-trans retinoic acid…
- Trial name
- NCT04282668
- Testing
- TAS1440, TAS1440 + ATRA
- Where
- 8 sites in United States
- Volunteers
- 52 people
- Sponsor
- Taiho Oncology, Inc.
Relapsed/Refractory Leukemias, Acute Lymphoblastic Leukemia
A Study of Revumenib in Combination With Chemotherapy in Participants With R/R Acute Leukemia
The purpose of this study is to determine the safety and tolerability of revumenib when given in combination with 2 different chemotherapy regimens in participants with relapsed/refractory acute leukemias harboring KMT2A…
- Conditions
- Relapsed/Refractory Leukemias, Acute Lymphoblastic Leukemia, Acute Lymphocytic Leukemia, Mixed Phenotype Acute Leukemia
- Trial name
- NCT05326516
- Testing
- Revumenib, Chemotherapy Regimen 1, Chemotherapy Regimen 2
- Where
- 11 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Syndax Pharmaceuticals
ECG, Pharmacokinetics
Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML
This is a single-arm, open-label, Phase 4 study evaluating the effect of GO on the QTc, pharmacokinetics, safety, and immunogenicity of GO as a single-agent monotherapy in adult and pediatric patients with relapsed or refractory…
- Conditions
- ECG, Pharmacokinetics, Safety
- Trial name
- NCT03727750
- Testing
- Gemtuzumab Ozogamicin
- Where
- 24 sites in United States, Canada and 4 more
- Volunteers
- 51 people
- Sponsor
- Pfizer
Acute Myeloid Leukemia, Myeloproliferative Neoplasm
A Study of TAS1553 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML) and Other Myeloid Neoplasms
This is a Phase 1, 2-part, open-label, multicenter, first-in-human (FIH) study to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of TAS1553 administered orally to participants…
- Conditions
- Acute Myeloid Leukemia, Myeloproliferative Neoplasm, Myelodysplastic/Myeloproliferative Neoplasm
- Trial name
- NCT04637009
- Testing
- TAS1553
- Where
- 10 sites in United States, Canada
- Volunteers
- 20 people
- Sponsor
- Astex Pharmaceuticals, Inc.
Acute Myeloid Leukemia (AML)
A Study of SKLB1028 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory (R/R) AML With FLT3-Mutated
This is a randomized，multicenter, open-label Phase III, clinical study to confirm the efficacy and safety of SKLB1028 in patients with relapsed or refractory(R/R) FLT3-Mutated Acute Myeloid Leukemia（AML）compared to salvage…
- Trial name
- ALIVE (NCT04716114)
- Testing
- SKLB1028, Salvage Chemotherapy
- Where
- China
- Volunteers
- 315 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
The goal of this clinical trial is to learn if sonrotoclax (BGB-11417) is safe and may help treat children and adolescents with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) that has come back after treatment…
- Conditions
- Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, B-cell Acute Lymphoblastic Leukemia, Pediatric Cancer
- Trial name
- NCT07770698
- Testing
- sonrotoclax, Azacitidine, Inotuzumab ozogamicin
- Volunteers
- 30 people
- Sponsor
- BeOne Medicines
Relapsed/Refractory Acute Myeloid Leukemia (AML)
Pilot Study of Crenolanib Combined With Standard Salvage Chemotherapy in Subjects With R/R AML
The proposed study is designed to combine crenolanib with standard salvage chemotherapy to treat patients with R/R AML irrespective the FLT3 status.
- Trial name
- NCT02626338
- Testing
- Crenolanib, Mitoxantrone, Cytarabine
- Where
- 4 sites in United States
- Volunteers
- 16 people
- Sponsor
- Arog Pharmaceuticals, Inc.
Relapsed Acute Myeloid Leukemia (AML), Refractory Acute Myeloid Leukemia (AML)
Phase 1 Study of AUTX-703 in Relapsed/Refractory AML and MDS
This Phase 1, multicenter, open-label, dose escalation and dose optimization study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of AUTX-703…
- Conditions
- Relapsed Acute Myeloid Leukemia (AML), Refractory Acute Myeloid Leukemia (AML), Relapsed/Refractory AML, Relapsed Myelodysplastic Syndromes
- Trial name
- NCT06846606
- Testing
- AUTX-703
- Where
- 9 sites in United States
- Volunteers
- 69 people
- Sponsor
- Auron Therapeutics, Inc.