Maintenance Venetoclax in AML Fit Patients

Sohag University

Status: Enrolling

Conditions: Acute Myeloid Leukaemia (AML)

Treatments: Drug: SC cytarabine +Venetoclax

Study type: Interventional

Funder types: Other

Identifiers

NCT07244367

Soh-Med-25-9---3MD

Details and patient eligibility

About

this study will explore the efficacy of maintenance SC cytarabine + venetoclax therapy as regard disease free survival (DFS) in AML fit patients who achieved CR after highly aggressive chemotherapy as bridge for BMT or if BMT will be delayed or canceled due to any other reason.

Full description

this study is a prospective,phase III , randomized ,open , interventional study include young fit patients who will receive maintenance venetoclax +subcutaneous cytarabine as bridge for BMT or if BMT will be delayed

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age : 18 - 60 years . Patients who are not eligible for immediate bone marrow transplantation. Newly diagnosed AML patients who attained CR after 1st line. Refractory / recurrant AML patients who attained CR after 2nd line .

Exclusion criteria

• Patients not on CR . Age : younger than 18 or older than 60 . Patients not eligible for bone marrow transplation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Arm A

Active Comparator group

Description:

will receive SC cytarabine + venetoclax till bone marrow transplantation or for 12 cycles for patient will not undergo BMT , SC Cytarabine (20 mg) administrated on days 1-7 , Venetoclax (100 mg ) administrated on days 1-7 , Voriconazole 200 mg 1x2 administrated on days 1-7 + best supportive care BSC

Treatment:

Drug: SC cytarabine +Venetoclax

Arm B

No Intervention group

Description:

Patients Will receive Best supportive care( BSC )only