Clinical trials: Relapsed AML
Treatment-naive or Relapsed or Refractory Acute Myeloid Leukemia (AML)
A Study to Evaluate the Tolerance and Efficacy of Mitoxantrone Hydrochloride Liposome Injection Combined With Cytarabine in Patients With Acute Myeloid Leukemia (AML)
This is an open-label, multi-cohort, multi-center Phase Ib/II clinical study to evaluate the tolerance and efficacy of Mitoxantrone Hydrochloride liposome injection combined with cytarabine in patients with Acute Myeloid Leukemia…
- Trial name
- NCT05100303
- Testing
- Mitoxantrone Hydrochloride liposome injection, Cytarabine (LoDAC)
- Where
- China
- Volunteers
- 58 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Leukemia, Myeloid
Phase II Study of AS1411 Combined With Cytarabine to Treat Acute Myeloid Leukemia
The overall aim of this study is to assess the efficacy and safety of AS1411, over a range of doses, when combined with cytarabine, in the treatment of patients with primary refractory or relapsed acute myeloid leukemia (AML).
- Trial name
- NCT00512083
- Testing
- AS1411
- Where
- 10 sites in United States, New Zealand
- Volunteers
- 70 people
- Sponsor
- Antisoma Research
Acute Myeloid Leukemia, Relapsed Adult AML
Venetoclax, Azacitidine, and Lintuzumab-Ac225 in AML Patients
The study is a multicenter, open label Phase I/II trial. 1. To determine the maximum tolerated dose (MTD) of lintuzumab-Ac225 when given in combination with venetoclax and azacitidine for patients with CD33 positive AML.
- Trial name
- NCT03932318
- Testing
- Lintuzumab-Ac225, Venetoclax, Azacitidine
- Sponsor
- Actinium Pharmaceuticals
Acute Myeloid Leukemia
A Study of Decitabine (DACOGEN) in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia
The purpose of this study is to examine the safety and efficacy of decitabine in sequential administration with cytarabine in children with relapsed or refractory acute myeloid leukemia (AML).
- Trial name
- NCT01853228
- Testing
- Phase1 and Phase 2: decitabine, Phase 1: cytarabine, Phase 2: cytarabine
- Where
- 17 sites in Belgium, Denmark and 5 more
- Volunteers
- 17 people
- Sponsor
- Janssen Research & Development, LLC
Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL)
Pharmacokinetic and Pharmacodynamic Assessment of Treatment With CPX-351 (Cytarabine: Daunorubicin) Liposome for Injection in Acute Leukemias and MDS Patients With Moderate Hepatic Impairment
To assess the impact of moderate hepatic impairment on cytarabine and daunorubicin pharmacokinetics and their metabolites following administration of CPX-351.
- Conditions
- Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS)
- Trial name
- NCT02269579
- Testing
- CPX-351
- Where
- 5 sites in United States
- Sponsor
- Jazz Pharmaceuticals
Myelodysplastic Syndromes, Higher Risk Myelodysplastic Syndromes
Study of REM-422 in Patients With AML or Higher Risk MDS
The goal of this study is to determine the safety and antitumor effects of REM-422, a MYB mRNA degrader, in people with Higher Risk MDS and relapsed/refractory AML
- Conditions
- Myelodysplastic Syndromes, Higher Risk Myelodysplastic Syndromes, Acute Myeloid Leukemia, Acute Myeloid Leukemia Refractory
- Trial name
- NCT06297941
- Testing
- REM-422
- Where
- 9 sites in United States, France
- Volunteers
- 100 people
- Sponsor
- Remix Therapeutics
Relapsed / Refractory AML, Relapsed / Refractory MDS
Safety, Pharmacokinetics, and Preliminary Efficacy of BYON4413 in Acute Myeloid Leukemia and Myelodysplastic Neoplasms.
This is the first-in-human trial with BYON4413 to evaluate safety, PK, immunogenicity, and anti-leukemia activity of BYON4413 in patients with AML or MDS.
- Trial name
- NCT06359002
- Testing
- BYON4413
- Where
- 9 sites in Belgium, Netherlands and 1 more
- Volunteers
- 16 people
- Sponsor
- Byondis B.V.
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
Acute Myeloid Leukemia (AML)
A Phase 2 Clinical Study of Ziftomenib in Patients With Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia
This is the first study to administer ziftomenib to Japanese patients. In this study, the efficacy, safety, and pharmacokinetics of ziftomenib will be evaluated in patients with relapsed or refractory NPM1-mutated acute myeloid…
- Trial name
- NCT07623616
- Testing
- ziftomenib
- Where
- 20 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed/Refractory B-cell Non-Hodgkin Lymphoma or CLL/SLL
Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies
Phase 1/2 umbrella study evaluates biomarker-selected dual-target CAR-T cell modules for adults with relapsed or refractory hematologic malignancies.
- Conditions
- Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed/Refractory B-cell Non-Hodgkin Lymphoma or CLL/SLL, Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia, Relapsed/Refractory Acute Myeloid Leukemia, High-risk Myelodysplastic Neoplasm
- Trial name
- ADAPT-HEM (NCT07523555)
- Testing
- Autologous CD19/CD22 dual-target CAR-T module, Autologous CD19/CD20 dual-target CAR-T module, Autologous BCMA/CD19 dual-target CAR-T module
- Where
- China
- Volunteers
- 96 people
- Sponsor
- Beijing Biotech
Acute Myeloid Leukemia
Phase 1/2 Safety and Efficacy of PLX3397 in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)
The purpose of this study is to evaluate the safety of study drug PLX3397 at 3 dose levels (800 mg/day, 1000 mg/day, and 1200 mg/day) and explore the efficacy in patients with relapsed or refractory acute myeloid leukemia (AML).
- Trial name
- NCT01349049
- Testing
- PLX3397
- Where
- 9 sites in United States
- Volunteers
- 90 people
- Sponsor
- Daiichi Sankyo
Relapsed/Refractory AML
Study to Evaluate the Efficacy of Uproleselan in Combination With Chemotherapy in Chinese Patients With R/R AML
This bridging study will evaluate the efficacy of uproleselan, a specific E-selectin antagonist, in combination with chemotherapy to treat Chinese relapsed/refractory AML patients, compared to chemotherapy alone.
- Trial name
- NCT05054543
- Testing
- Uproleselan
- Where
- 2 sites in China
- Volunteers
- 140 people
- Sponsor
- Apollomics Inc.
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
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory
An Adaptive Open-label Multicentre Phase 1/2 Trial, to Determine the Recommended Phase 2 Dose of CCTx-001, and to Assess Safety, Tolerability, and Clinical Activity in Patients With Relapsed/Refractory Acute Myeloid Leukaemia
The purpose of this adaptive Phase 1/2 study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antileukemic activity of CCTx-001 in adult patients with r/r Acute Myeloid Leukemia (AML).
- Trial name
- RESOLVE AML001 (NCT06281847)
- Testing
- CCTx-001
- Where
- 6 sites in France, Germany and 2 more
- Volunteers
- 143 people
- Sponsor
- Advesya SAS
Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL)
A Study of Voruciclib Alone or in Combination With Venetoclax in Subjects With B-Cell Malignancies or AML
This is a Phase 1, open-label, dose escalation study to determine the safety and preliminary efficacy of voruciclib monotherapy in subjects with relapsed/refractory B cell malignancies or AML after failure of standard therapies…
- Conditions
- Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), Small Lymphocytic Lymphoma (SLL)
- Trial name
- NCT03547115
- Testing
- voruciclib monotherapy, voruciclib and venetoclax
- Where
- 12 sites in United States
- Volunteers
- 84 people
- Sponsor
- MEI Pharma, Inc.
Acute Myelogenous Leukemia, Myelodysplastic Syndrome
Safety and Efficacy Study of PD-616 Plus Cytarabine to Treat Acute Myelogenous Leukemia or Myelodysplastic Syndrome
The purpose of this study is to determine whether PD-616 in combination with low-dose Cytarabine is safe and effective in the treatment of untreated or relapsed/refractory acute myelogenous leukemia (AML) or high-risk…
- Trial name
- AML/MDS (NCT01795924)
- Testing
- PD-616
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- Biosuccess Biotech Co., Ltd.
Relapsed/Refractory Acute Myeloid Leukemia
Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Efficacy of Bl-M11D1
The objective of this study to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of BL-M11D1 in patients with relapsed/refractory acute myeloid leukemia.
- Trial name
- NCT06714591
- Testing
- BL-M11D1
- Where
- 18 sites in United States
- Volunteers
- 52 people
- Sponsor
- SystImmune Inc.
Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia
Study of Fosciclopirox in Patients With Relapsed/Refractory Acute Myeloid Leukemia
This will be an open-label, Phase 1B/2A, study to characterize the efficacy, safety, pharmacokinetics, and pharmacodynamics of fosciclopirox administered alone and in combination with cytarabine in patients with R/R AML with up…
- Trial name
- NCT04956042
- Testing
- Fosciclopirox, Fosciclopirox + Cytarabine
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- CicloMed LLC
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
Advanced Solid Tumor, TNBC - Triple-Negative Breast Cancer
BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia
This study is a multiple cohort, multicenter, open-label Phase 1 study with dose-escalation substudies investigating intravenous (IV) BAL0891 as monotherapy, and in combination with tislelizumab or paclitaxel, to determine the…
- Conditions
- Advanced Solid Tumor, TNBC - Triple-Negative Breast Cancer, Gastric Cancer, Leukemia Acute Myeloid Leukemia (AML)
- Trial name
- NCT05768932
- Testing
- BAL0891, Tislelizumab, Paclitaxel
- Where
- 17 sites in United States, South Korea
- Volunteers
- 260 people
- Sponsor
- SillaJen, Inc.