Leukemia, Myeloid, Acute Clinical Trial
Official title:
To Evaluate Safety and Efficacy of Azacitidine Combination With Venetoclax for Treatment of Newly Diagnosed Fit Acute Myeloid Leukemia Patients：A Multicenter, Single-arm Study
The goal of this clinical research study is to evaluate the safety and efficacy of Azacytidine in combination with Venetoclax in patients with newly diagnosed fit acute myeloid leukemia.
The Study Drug: Azacitidine is a DNA Demethylated drug, which is approvd for treatment of elderly AML patients Venetoclax targets the anti-apoptotic protein Bcl-2 and the process of oxidative phosphorylation to induce apoptosis of leukemia cells and exhibits anti-tumor activity. Study Group: single arm: AZA plus Venetoclax Study Drug Administration: Each course is 28 days long. Venetoclax is taken once daily by oral. The doses of Venetoclax is 100 mg on Day 1, 200 mg on Day 2, reaching a target dose of 400 mg on Day 3 and continuing through Day 28. If concomitantly receiving azoles, the dose of Venetoclax will be adjusted according to the instructions. Azacitidine is taken 75mg/m2 on Days 1-7. Subjects would received 1-2 cycles induction therapy. Once get remission, subjects would received the same indution therapy of middle to high dose of cytarabine based chemotherapy at the discretion of the physician for consolidation. Allo-HSCT is suggested for subjects with the moderate to adverse ELN2017 risk. Study Visit: After treatment, relapse and survival will be followed monthly by telephone, on-site visits, and/or study medical records for up to two years (calculated from the first day of induction therapy); Thereafter follow-up every 3 months for one year. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05319587 -
Study of Liposomal Annamycin in Combination With Cytarabine for the Treatment of Subjects With Acute Myeloid Leukemia (AML)
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04090736 -
Study to Compare Azacitidine Plus Pevonedistat Versus Azacitidine in Patients With Acute Myeloid Leukemia Not Eligible for Standard Chemotherapy
|
Phase 3 | |
| Completed |
NCT01617226 -
Randomised Study of Azacitidine Versus Azacitidine With Vorinostat in Patients With AML or High Risk MDS
|
Phase 2 | |
| Terminated |
NCT00916045 -
Pilot Study of Unrelated Cord Blood Transplantation
|
Phase 2 | |
| Terminated |
NCT00957580 -
Trial of Pimasertib in Hematological Malignancies
|
Phase 2 | |
| Completed |
NCT00640796 -
Pilot Study of Expanded, Donor Natural Killer Cell Infusions for Refractory Non-B Lineage Hematologic Malignancies and Solid Tumors
|
Phase 1 | |
| Completed |
NCT00458250 -
Feasibility of Haploidentical Hematopoietic Stem Cell Transplantation Using CAMPATH-1H
|
Phase 1 | |
| Active, not recruiting |
NCT05424380 -
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
|
Phase 1 | |
| Completed |
NCT01690624 -
BI 836858 Dose Escalation in Patients With Refractory or Relapsed Acute Myeloid Leukemia and in Patients in Complete Remission With High Risk to Relapse
|
Phase 1 | |
| Not yet recruiting |
NCT05016063 -
Dual CD33-CLL1-CAR-T Cells in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
|
Early Phase 1 | |
| Not yet recruiting |
NCT04450784 -
ObServatory Children Acute RElated Therapy Leukemia
|
||
| Recruiting |
NCT04265963 -
CD123-Targeted CAR-T Cell Therapy for Relapsed/Refractory Acute Myeloid Leukemia
|
Phase 1/Phase 2 | |
| Terminated |
NCT04968860 -
Oral Health Condition and Quality of Life in Children With Leukemia
|
||
| Recruiting |
NCT03793517 -
Decitabine Plus mBU/CY for High Risk Acute Leukemia With MRD Pre-HSCT
|
Phase 2/Phase 3 | |
| Terminated |
NCT02841540 -
A Study of H3B-8800 (RVT-2001) in Participants With Lower Risk Myelodysplastic Syndromes
|
Phase 1 | |
| Recruiting |
NCT05453903 -
A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies
|
Phase 1 | |
| Completed |
NCT03720366 -
A Study of Perpetrator Drug Interactions of Enasidenib in AML Patients
|
Phase 1 | |
| Withdrawn |
NCT04230564 -
Acute Myeloid Leukemia Real World Treatment Patterns
|
||
| Terminated |
NCT03761069 -
Study of PTC299 (Emvododstat) in Relapsed/Refractory Acute Leukemias
|
Phase 1 | |
| Completed |
NCT01835587 -
Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Participants With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS).
|
Phase 1/Phase 2 |