Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The project was terminated as the genetic office did not approve it.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Daunorubicin, Cytarabine Liposomes(CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.) is a dual-drug liposomal encapsulation of cytarabine and daunorubicin at a fixed 5:1 synergistic molar ratio.
This is a phase 2, randomized, controlled study in patients who are >= 18 or more years old and have not been treated before. Participants who take part in this study should not be suitable for intensive induction therapy.
In this study, patients will be randomized by 1:1:1 to receive Daunorubicin, Cytarabine Liposomes + Venetoclax(14d) or Daunorubicin, Cytarabine Liposomes + Venetoclax(21d) or Venetoclax + Azacitidine.
Participants will continue to have study visits and receive treatment for as long as they are having a clinical benefit.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ArmA(daunorubicin, cytarabine liposomes plus 14d-venetolcax) | Experimental | Patients receive daunorubicin, cytarabine liposomes through intravenous injection(IV) on days 1、3、5, and venetoclax orally(PO) daily on days 1-14. Treatment repeats every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. |
|
| ArmB(daunorubicin, cytarabine liposomes plus 28d-venetolcax) | Experimental | Patients receive daunorubicin, cytarabine liposomes IV on days 1、3、5, and venetoclax PO daily on days 1-28. Treatment repeats every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. |
|
| ArmC(azacitidine plus 28d-venetoclax) | Active Comparator | Patients receive azacitidine subcutaneously (SC) on days 1-7, and venetoclax PO daily on days 1-28. Treatment repeats every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| daunorubicin, cytarabine liposomes | Drug | First induction: 100 units/m^2 by 90-minute IV infusion on Days 1, 3, 5. Second induction: 100 units/m^2 by 90-minute IV infusion on Days 1 and 3. Consolidation therapy: 65 units/m^2 by 90-minute IV infusion on Days 1 and 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate(CR) | Proportion of patients with complete remission during the treatment period. | Up to 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Composite complete remission rate(cCR) | Proportion of CR and complete remission with incomplete count recovery(CRi) | Up to 8 months |
| Proportion of pateints who achieve Measurable residual disease(MRD) negativity |
Not provided
Inclusion Criteria:
Participant must have confirmation of Acute Myeloid Leukemia (AML) by 2022 World Health Organization (WHO) criteria, previously untreated.
Participant must be >= 18 years of age.
Participant must have a projected life expectancy of at least 12 weeks.
Participant must be considered ineligible for intensive induction therapy defined by the following:
a. >= 75 years of age; b. >= 18 to 74 years of age with at least one of the following comorbidities: i. Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or 3; ii. Cardiac history of Congestive Heart Failure (CHF) requiring treatment or Ejection Fraction <= 50% or chronic stable angina; iii. Diffusing capacity of the Lung for Carbon Monoxide (DLCO) <= 65% or Forced Expiratory Volume in 1 second (FEV1) <= 65%; iv. Creatinine clearance >= 30 mL/min to < 45 ml/min; v. Moderate hepatic impairment with total bilirubin > 1.5 to <= 3.0 × Upper Limit of Normal (ULN); vi. Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy.
Participant must have an ECOG Performance status:
0 to 2 for Participants >= 75 years of age or 0 to 3 for Participants >= 18 to 74 years of age. 6.Laboratory values meet the following criteria:
Serum alanine aminotransferase or aspartate aminotransferase≤3 × ULN, ≤5 × ULN for patients with liver involvement.
For participants of ≥ 75 years old: Serum total bilirubin≤1.5 × ULN, ≤3 × ULN for patients with liver involvement
For participants of 18 to 74 years old: Serum total bilirubin≤ 3× ULN
Adequate renal function as demonstrated by a creatinine >= 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection.
7.Male participants who are sexually active, must agree, from Study Day 1 through at least 6 months after the last dose of study drug, to practice the protocol specified contraception and agree to refrain from sperm donation during this period.
8.Female participants of childbearing potential must practice the protocol specified contraception from Study Day 1 through at least 6 months after the last dose of study drug. Female participants must agree to refrain from preganancy, breastfeeding or egg donation during this period. Female participants of childbearing potential must have negative results for pregnancy test performed: At Screening with a serum sample obtained within 7 days prior to the first study drug administration.
9.Participant must able to understand the study and voluntarily sign informed consent.
-
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Azacitidine | Drug | Given SC on days 1-7 |
|
| Venetoclax | Drug | Given PO on days 1-14 or 1-21 or 1-28 |
|
The percentage of patients who are MRD negative
| Up to 8 months |
| Event-free survival (EFS) | EFS is defined as the time from study randomization to the date of induction treatment failure, disease relapse or death from any cause, whichever occurs first. | Up to 2 years |
| Overall survival (OS) | Overall survival will be measured from the date of randomization to death from any cause. | Up to 2 years |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D001374 | Azacitidine |
| C579720 | venetoclax |
| ID | Term |
|---|---|
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D001372 | Aza Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
Not provided
Not provided