Maintenance Venetoclax in AML Fit Patients

NCT ID: NCT07244367

Last Updated: 2025-11-24

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

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-09-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Acute Myeloid Leukaemia (AML)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

this study is a prospective,phase III , randomized ,open , interventional study. double blind, placebo control clinical trial . Evaluating efficacy of maintenance venetoclax based therapy in Acute meyloid leukemia fit patients who acheived complete remission after standard induction and consolidation therapy.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arm A

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

Group Type ACTIVE_COMPARATOR

SC cytarabine +Venetoclax

Intervention Type 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

Arm B

Patients Will receive Best supportive care( BSC )only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SC cytarabine +Venetoclax

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

Intervention Type DRUG

Other Intervention Names

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Venclexta

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Eman Ibrahim Abdelshakour

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elsayed M Ali, Professor

Role: STUDY_DIRECTOR

Faculty of medicine sohag university

Locations

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Sohag university hospital

Sohag, , Egypt

Site Status RECRUITING

Sohag university

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Eman I Abdelshakour, Asst lect

Role: CONTACT

+201063901450 ext. +201122103385

Walaa G Mohamed, Lecturer

Role: CONTACT

Facility Contacts

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Eman I Abdelshakour, Asst lect

Role: primary

+201063901450 ext. +201122103385

Eman I Abdelshakour, Asst lect

Role: primary

+201063901450 ext. +201122103385

References

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1. Papaemmanuil E, Gerstung M, Bullinger L, Gaidzik VI, Paschka P, Roberts ND, et al. Genomic classification and prognosis in acute myeloid leukemia. N Engl J Med. 2016;374:2209-21. 2. DiNardo CD, Erba HP, Freeman SD, Wei AH. Acute myeloid leukaemia. Lancet. 2023;401:2073-86. 3. Miranda-Filho A, Piñeros M, Ferlay J, et al: Epidemiological patterns of leukaemia in 184 countries: A population-based study. Lancet Haematol 5:e14-e24, 2018

Reference Type RESULT

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id

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