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Trial Title:
Treatment With ABT-199 (Venetoclax) and Purine Analogues in Relapsed/Refractory Acute Myeloid Leukemia
NCT ID:
NCT05506332
Condition:
Acute Myeloid Leukemia, in Relapse
Acute Myeloid Leukemia Refractory
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Venetoclax
Mercaptopurine
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
Venetoclax and 6-mercaptopurine
Arm group label:
Venetoclax and 6-mercaptopurine
Intervention type:
Drug
Intervention name:
6-mercaptopurine
Description:
Venetoclax and 6-mercaptopurine
Arm group label:
Venetoclax and 6-mercaptopurine
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.
Detailed description:
Non-commercial, open-label interventional phase Ib study. The aim of the study is to
assess the effectivity of the combination of venetoclax and 6-mercaptopurine in patients
with relapsed or refractory AML.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
- ABT-199 (venetoclax) and PA-naïve. Patient may be prior exposed but not refractory
to venetoclax. In case of previous therapy with venetoclax inclusion is only
possible after discussion with the PI.
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Antwerp
Address:
City:
Edegem
Zip:
2650
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Sébastien Anguille, Prof. Dr.
Facility:
Name:
AZ Delta
Address:
City:
Roeselare
Zip:
8800
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Dries Deeren, Dr.
Start date:
July 15, 2022
Completion date:
December 2026
Lead sponsor:
Agency:
University Hospital, Antwerp
Agency class:
Other
Source:
University Hospital, Antwerp
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05506332
