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

Sponsor
Hospital Universitario Dr. Jose E. Gonzalez (Other)
Overall Status
Recruiting
CT.gov ID
NCT05048615
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
11.2
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Venetoclax 100 MG
  • Drug: Itraconazole capsule
  • Drug: Azacitidine Injection
 Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
A consecutive sample of 15 patients with newly diagnosed AML will be prospectively included in this study.A consecutive sample of 15 patients with newly diagnosed AML will be prospectively included in this study.
Masking:
None (Open Label)
Masking Description:
This is an Open label study
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Ambulatory Low-dose Venetoclax and Azacitidne as First Line Therapy in Newly Diagnosed AML: a Pilot Study
Actual Study Start Date :
Jul 26, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: 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.
Other Names:
  • Venclexta

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

    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.

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility will be address by obtaining the proportion of patients who need hospitalization [1 month]

      If therapy is feasible >50% of patients will recieve their first cycle of treatment without hospitalization

    2. Safety will be defined by the number of patients deceased before 14 days of initiating treatment [2 weeks]

      If therapy is safe then <5% of patients will die in the first 14 days of treatment

    Secondary Outcome Measures

    1. Efficacy will be achieved if the overall response rate is similar to standard of care (7+3) [2 months]

      If the therapy is effective then overall response rates will be similar to those reported with standard of care (7+3)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Andres Gomez Monterrey Nuevo LEON Mexico 64710

    Sponsors and Collaborators

    • Hospital Universitario Dr. Jose E. Gonzalez

    Investigators

    • Principal Investigator: David Gomez-Almaguer, Universidad Autonoma de Nuevo Leon

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    David Gomez Almaguer, Head of Hematology Service, Hospital Universitario Dr. Jose E. Gonzalez
    ClinicalTrials.gov Identifier:
    NCT05048615
    Other Study ID Numbers:
    • HE21-00014
    First Posted:
    Sep 17, 2021
    Last Update Posted:
    Sep 17, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by David Gomez Almaguer, Head of Hematology Service, Hospital Universitario Dr. Jose E. Gonzalez
    acute myeloid leukemia
    venetoclax
    azacitidine
    first-line therapy
    induction chemotherapy
    Additional relevant MeSH terms:
    Itraconazole
    Azacitidine
    Venetoclax

    Study Results

    No Results Posted as of Sep 17, 2021