Treatment With ABT-199 (Venetoclax) and Purine Analogues in Relapsed/Refractory Acute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Antwerp
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Venetoclax
DrugVenetoclax and 6-mercaptopurine
6-mercaptopurine
DrugVenetoclax and 6-mercaptopurine
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Venetoclax and 6-mercaptopurineExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Clinical response
Objective response rate
Time frame
at 2 months2
Clinical response
Objective response rate
Time frame
at 6 months3
Clinical response
Objective response rate
Time frame
at 2 yearsSponsors and contacts
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Source ClinicalTrials.gov