Treatment With ABT-199 (Venetoclax) and Purine Analogues in Relapsed/Refractory Acute Myeloid Leukemia

NCT05506332 | Recruiting Phase 1

• 2 other identifiers: 22822021-006473-35
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

Non-commercial, open-label interventional phase Ib study to assess the effectivity of the combination of venetoclax and 6-mercaptopurine in patients with relapsed or refractory AML.

Conditions

Acute Myeloid Leukemia, in Relapse; Acute Myeloid Leukemia Refractory

Outcome Measures

Primary Outcomes (3)

• Clinical response

  Objective response rate

  at 2 months

• Clinical response

  Objective response rate

  at 6 months

• Clinical response

  Objective response rate

  at 2 years

Study Arms (1)

Venetoclax and 6-mercaptopurine

EXPERIMENTAL

Single arm study with venetoclax and 6-mercaptopurine administered in two to six cycles of 28 days. Venetoclax is given at a dosage of 600mg with dose reduction in case of interaction with a moderate or strong CYP3A4 inhibitor. 6-mercaptopurine is given at a dosage of 100mg.

Drug: Venetoclax; Drug: 6-mercaptopurine

Interventions

Venetoclax DRUG

Venetoclax and 6-mercaptopurine

Venetoclax and 6-mercaptopurine

6-mercaptopurine DRUG

Venetoclax and 6-mercaptopurine

Venetoclax and 6-mercaptopurine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Relapsed or refractory AML
• Relapsed after or refractory to at least one cycle of intensive chemotherapy (combination of ara-c/anthracyclin) or four cycles of HMA (hypomethylating agents)
• Adult AML aged \>/= 18 years
• WHO performance status: grade 0-2 at the time of enrollment

You may not qualify if:

• Participation in any other interventional clinical trial during the study period
• Active presence (or known history of) central nervous system disease
• History or concomitant presence of any other malignancy, except for non-melanoma skin cancer, carcinoma in situ of the cervix, any other effectively treated malignancy that has been in remission for \>5 years or that is highly likely to be cured at the time of enrollment.
• Active HIV, hepatitis B or hepatitis C infection
• Use of any antitumoral agent within less than 5 times the half-life of the agent prior to the screening bone marrow examination. After the screening bone marrow examination, the use of cytoreductive treatment prior to the initiation of venetoclax is permitted in order to lower the WBC-count to \<25 000/µl (e.g. hydroxyurea).
• Medical conditions requiring chronic therapy of moderate or strong CYP3A4 inducers without alternative
• Patients with known hypersensitivity to the active substance or to any of the excipients
• Pregnant or breastfeeding woman
• Active uncontrolled systemic infection

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (2)

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

RECRUITING

AZ Delta

Roeselare, West Vlaanderen, 8800, Belgium

NOT YET RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax; Mercaptopurine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Sulfhydryl Compounds; Sulfur Compounds; Organic Chemicals; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sébastien Anguille, Prof. Dr.

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sébastien Anguille, Prof. Dr.

CONTACT

0032 3 821 3356; studies.hematologie@uza.be

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 18, 2022
• Study Start: July 15, 2022
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)