Maintenance Venetoclax in AML Fit Patients

ConditionAcute Myeloid Leukaemia (AML)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-60

SponsorSohag University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 .

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

SC cytarabine +Venetoclax
Drug
SC Cytarabine (20 mg) administrated on days 1-7 ,,Venetoclax (100 mg ) administrated on days 1-7,,Voriconazole 200 mg 1x2 administrated on days , Best supportive care as needed . Up to 12 cycles or until patients undergo bone marrow transplantation

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Arm AActive comparator 1 intervention

Group B: Arm BNo intervention 0 interventions

Trial outcomes

Primary outcomes

Disease free survival DFS

time from complet remission to relapse or death from any cause in AML fit patients receiving maintenance SC cytarabine plus venetoclax after intensive chemotherapy

Time frame

24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sohag University

Lead sponsor

Source ClinicalTrials.gov

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