A Clinical Study of VA-CAG as Induction Therapy in Newly Diagnosed AML Patients

Browse trials for

• Leukemia, Myeloid, Acute 2,971

Keywords

• Venetoclax
• Azacitidine
• Granulocyte colony-stimulating factor(G-CSF)
• Cytarabine
• Aclarubicin

Leukemia, Myeloid, Acute

2,971 studies on the registry are indexed under Leukemia, Myeloid, Acute; 745 are open to participants now.

This study's enrollment of 114 is above the median of 41 across 2,509 interventional studies indexed under Leukemia, Myeloid, Acute.

Lead sponsor

Hematology department of the 920th hospital is the lead sponsor of 10 studies on the registry; 7 are open to participants now.

Study arms

• Experimental
  Treatment group

  Induction: Subjects who meet the enrollment conditions will receive Venetoclax plus Azacitidine and CAG(VA-CAG) . Participants will receive this induction Therapy as azacitidine on days 1-7, venetoclax aily on days 1-28, cytarabine q12h on days 1-7, aclacinomycin on days 1,3,5,7, and granulocyte colony-stimulating factor on days 0-8. Participants will receive second induction if not reach complete remission. Consolidation: If patients are intermediate or poor risk and have plans for allogeneic hematopoietic stem-cell transplantation(allo-HSCT) , high dose cytarabine (3g/m2 q12h days 1-3) for 1-2 cycles and follow up with allo-HSCT. In other cases, high dose cytarabine for 4 cycles.

  Drug: Venetoclax in combination with azacitidine and CAG

Interventions

• DrugVenetoclax in combination with azacitidine and CAG

  Induction: VA regimen： Drug: Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-21); Drug: Azacitidine 75 mg/m2 subcutaneously once daily on days 1-7. CAG regimen： Drug: Cytarabine 10mg/m2 subcutaneously q12h on days 1-7; Drug: Aclacinomycin 12-14mg/m2 on days 1,3,5,7; Drug: Granulocyte colony-stimulating factor 5ug/kg on days 0-8, discontinue if WBC \>20×10\^9/L； Consolidation: Drug: Cytarabine 3g/m2 q12h on days 1-3.

  Also known as: VA-CAG regimen

Primary outcomes

1. CR rate

   Time frame: At the end of Cycle 1 of induction (each cycle is about 30 days)

Secondary outcomes

1. Adverse Events

   Safety and tolerability analysis will be assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.

   Time frame: From the first day of induction until the starting day of the next cycle of therapy (up to 60 days）

2. Duration of remission

   DOR was defined as the period from the time to acquire CR until relapse

   Time frame: From the date of the first remission until the date of relapse (assessed up to 30 months)

3. Minimal Residual Disease negative remission rate (MRD-negative rate)

   Percentage of participants who converted to MRD \< 10\^-3 by flow cytometry before initiation of consolidation therapy.

   Time frame: After 1 cycle of induction (each cycle is about 30 days)

Other outcomes

1. Overall survival

   Overall Survival will be defined as the time from administration of the initial doses until death from any cause.

   Time frame: From the first day of induction until the date of death from any cause, assessed up to 30 months

2. Relapse-free survival

   Relapse-free survival will be defined as the time since date of CR until either relapse or death in remission.

   Time frame: From the first day of induction until the date of relapse or the date of death from any cause, assessed up to 30 months