Low-dose Venetoclax and Azacitidine as Front-line Therapy in Newly Diagnosed AML

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-26

Study Completion Date

2023-01-20

Brief Summary

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Venetoclax plus azacitidine are effective in treating newly diagnosed AML in patients who cannot recieve intensive chemotherapy. However there is no clinical data rewarding the efficacy and safety of low-dose venetoclax and azacitidine as first-line therapy.

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Detailed Description

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Venetoclax plus azacitidine are effective in treating newly diagnosed AML in patients who cannot recieve intensive chemotherapy. However there is no clinical data rewarding the efficacy and safety of low-dose venetoclax and azacitidine as first-line therapy. This phase 2 clinical trial will explore the efficacy and safety of low-dose venetoclax (100mg /day/21 days) and a fixed dose of azacitidine (75mg/m2, maximun dose 100mg, SC for seven consecutive days) for a maximun of two cycles.

Conditions

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AML

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A consecutive sample of 15 patients with newly diagnosed AML will be prospectively included in this study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an Open label study

Study Groups

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Low-dose Ventoclax and oral itraconazol plus subcutaneous Azacitdine

Patients will recieve Low-dose Venetoclax at a dose of 100mg/day por 21 days, oral itraconazol 100mg every 12 hours, and subcutaneous Azacitidine 75mg/m2 (maximun dose 100mg) daily for seven days. Each cycle duration is 21 days and patients will recieve a maximun of two cycles.

Group Type EXPERIMENTAL

Venetoclax 100 MG

Intervention Type DRUG

Patients will receive oral Venetoclax at a fixed dose of 100mg/day from day 1 to day 21 per cycle for a maximum of 2 cycles.

Itraconazole capsule

Intervention Type DRUG

Patients will receive oral itraconazole at a dose of 100 mg every 12 hours from day 1 to day 21.

Azacitidine Injection

Intervention Type DRUG

Patients will receive a maximum of two cycles of daily subcutaneous Azacitidine at a dose of 75 mg/m2 (maximum 100 mg) from day 1 to day 7.

Interventions

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Venetoclax 100 MG

Patients will receive oral Venetoclax at a fixed dose of 100mg/day from day 1 to day 21 per cycle for a maximum of 2 cycles.

Intervention Type DRUG

Itraconazole capsule

Patients will receive oral itraconazole at a dose of 100 mg every 12 hours from day 1 to day 21.

Intervention Type DRUG

Azacitidine Injection

Patients will receive a maximum of two cycles of daily subcutaneous Azacitidine at a dose of 75 mg/m2 (maximum 100 mg) from day 1 to day 7.

Intervention Type DRUG

Other Intervention Names

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Venclexta Vidaza

Eligibility Criteria

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Inclusion Criteria

1. Age \>18 years
2. Both genders
3. Diagnosis of non-m3 AML by the WHO 2016 diagnostic criteria
4. Patients eligible and not eligible for transplant
5. AML secondary to treatment or associated to myelodisplasia

Exclusion Criteria

1. AML with PML/RAR-alfa translocation t(15;17)
2. Central nervous system involvement
3. Poor functional status (ECOG\>2)
4. Organic dysfunction (Marshall score ≥2)
5. Active infection
6. Use of other CYP3A4 inhibitors
7. Pregnancy
8. GFR \<30 ml/min/1.72m2

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No