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Taking peoplePhase 1

Tests venetoclax with 6-mercaptopurine in adults with returned or non-responding acute myeloid leukemia

Tests venetoclax and 6-mercaptopurine together in adults with relapsed or refractory acute myeloid leukemia.

Key facts

Who runs it
University Hospital, Antwerp
Where
Edegem and Roeselare, BelgiumSee the 2 sites
Registry title
Treatment With ABT-199 (Venetoclax) and Purine Analogues in Relapsed/Refractory Acute Myeloid Leukemia
Status
Recruiting
Phase
Phase 1
People taking part
10 people, planned
Started
15 Jul 2022
Expected to end
Dec 2026
Type of study
Interventional
Treatments tested
  • Venetoclax
  • 6-mercaptopurine
Record updated
18 August 2022

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults whose acute myeloid leukemia (AML) came back or did not respond to earlier treatment. It tests venetoclax with 6-mercaptopurine.

Age
18 years or older
Sex
All sexes can join.
Disease stage
AML that came back (relapsed) or did not respond (refractory). WHO performance status 0-2 at enrollment.
Earlier treatment
Must have relapsed after, or not responded to, at least one cycle of intensive chemotherapy (ara-c plus anthracycline) or four cycles of hypomethylating agents (HMA). Must not have had venetoclax and purine analogues before. Earlier venetoclax is possible only if the leukemia was not resistant to it, after discussion with the principal investigator.

Main reasons for not taking part

  • Taking part in another interventional clinical trial during the study
  • Current or past central nervous system disease
  • Another cancer, apart from a few listed exceptions
  • Active HIV, hepatitis B or hepatitis C infection
  • Pregnant or breastfeeding women

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 presence (or known history of) central nervous system disease
  • Active HIV, hepatitis B or hepatitis C infection
  • 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
  • Active uncontrolled systemic 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)
  • Participation in any other interventional clinical trial during the study period
  • Pregnant or breastfeeding woman

Where in Belgium

  • Antwerp University HospitalEdegem, BelgiumNot yet recruiting
  • Algemeen Ziekenhuis DeltaRoeselare, BelgiumNot yet recruiting

About the trial

What the trial wants to find out

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.

The group in the trial

  • Venetoclax and 6-mercaptopurineTreatment being tested

    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.

    Treatment: Venetoclax and 6-mercaptopurine

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
ABT-199 (Venetoclax) and Purine Analogues as Novel Oral Drug Combination for Treatment of Relapsed/Refractory Acute Myeloid Leukemia: the ApoAML Trial
Plain-language title
Tests venetoclax with 6-mercaptopurine in adults with returned or non-responding acute myeloid leukemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
18 August 2022