Myeloid Malignancy Clinical Trial
Official title:
A Phase II Study of the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection, Cytarabine and Venetoclax in Patients With Relapsed/Refractory AML
The goal of this study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, cytarabine and venetoclax (MAV) in the treatment of relapsed or refractory (R/R) AML. It will also tentatively explore the correlation between different biological characteristics and therapeutic efficacy. The main questions it aims to answer are:Dose the combination regimen of MAV enhanced the composite complete remission in R/R AML? Participants will receive laboratory tests of bone marrow and blood specimens at regular times after MAV treatment.
Acute myeloid leukemia (AML) is a highly aggressive hematologic malignancy with a poor prognosis. The "3+7" regimen, combining anthracyclines with cytarabine, remains the standard treatment for first line treatment. However, about 20% of patients will develop into primary refractory disease, and more than 50% of patients who achieved complete remission will eventually relapse. For patients with R/R AML, there is currently no established standard treatment. Combining the third drugs with "3+7" regimen is one of the clinical exploration directions. The purpose of this prospective, single-center, single-arm, pahse II study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, cytarabine and venetoclax in the treatment of R/R AML. All participants will receive MAV treatment including 24 mg/m2 mitoxantrone hydrochloride liposome on day 1, 1.0 g/m2 q12h cytarabine on day 1,3,5 and 400 mg venetoclax on day 2-10 with a dose escalation on day 2-4. Each cycle consists of 4 weeks. A maximum of 2 cycles of therapy are planned. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04501120 -
Study of APG2575 Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT06090513 -
Molecular Services and EMR-Lab Integration Application (ELIA) for Reducing Healthcare Disparities in Cancer Patients
|
||
| Not yet recruiting |
NCT06129734 -
Decitabine and Venetoclax Treatment as Maintenance Therapy in Patients Post Allograft Stem Cell Transplant
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05579769 -
A Phase II Pediatric Study of a Graft-VS.-Host Disease (GVHD) Prophylaxis Regimen With no Calcineurin Inhibitors After Day +60 Post First Allogeneic Hematopoietic Cell Transplant for Hematological Malignancies
|
Phase 2 | |
| Recruiting |
NCT05583175 -
Venetoclax Plus RIC Regimen Allo-HSCT for Elderly Patients With High-risk Myeloid Malignancies
|
Phase 2 | |
| Recruiting |
NCT06378437 -
A Study of GLB-001 in Patients With Myeloid Malignancies
|
Phase 1 | |
| Terminated |
NCT01596699 -
Pilot Trial of Clofarabine Added to Standard Busulfan and Fludarabine for Conditioning Prior to Allogeneic Hematopoietic Cell Transplantation
|
Phase 2 | |
| Recruiting |
NCT04906031 -
Sodium Stibogluconate in the MDS/AML With One of the 65 Defined p53 Mutations
|
Phase 2 | |
| Recruiting |
NCT05455294 -
Combination Navitoclax, Venetoclax and Decitabine for Advanced Myeloid Neoplasms
|
Phase 1 | |
| Recruiting |
NCT03850418 -
Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant
|
Phase 2 | |
| Recruiting |
NCT02958462 -
Pre-myeloid Cancer and Bone Marrow Failure Clinic Study
|
N/A | |
| Recruiting |
NCT03855371 -
Mutant p53-based Personalized Trial Using Decitabine and Arsenic Trioxide on AML/MDS
|
Phase 1 | |
| Recruiting |
NCT05841771 -
Hypomethylating Agent and Venetoclax After Allo-HSCT in Patients With High-risk Myeloid Malignancies.
|
Phase 2 | |
| Completed |
NCT04214860 -
APR-246 in Combination With Venetoclax and Azacitidine in TP53-Mutant Myeloid Malignancies
|
Phase 1 | |
| Active, not recruiting |
NCT05350163 -
T-cell Receptor α/β Depleted Donor Lymphocyte Infusion
|
Phase 1 | |
| Not yet recruiting |
NCT05875805 -
A Telehealth Advance Care Planning Intervention
|
N/A |