Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05506332

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

Led by University Hospital, Antwerp · Updated on 2022-08-18

10

Participants Needed

2

Research Sites

228 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Relapsed or refractory acute myeloid leukemia (AML)
  • Relapsed after or refractory to at least one cycle of intensive chemotherapy or four cycles of hypomethylating agents
  • Adults aged 18 years or older
  • WHO performance status grade 0 to 2 at enrollment
  • Nafve to ABT-199 (venetoclax) and purine analogues, or prior exposure without refractory disease (inclusion after PI discussion if previously treated with venetoclax)
Not Eligible

You will not qualify if you...

  • Participation in any other interventional clinical trial during the study period
  • Active or history of central nervous system disease
  • History or presence of other malignancies except certain treated cancers in remission for over 5 years
  • Active HIV, hepatitis B, or hepatitis C infection
  • Use of antitumoral agents within less than five times their half-life before screening bone marrow exam
  • Medical conditions requiring chronic use of moderate or strong CYP3A4 inducers without alternatives
  • Known hypersensitivity to study drugs or excipients
  • Pregnant or breastfeeding women
  • Active uncontrolled systemic infection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University Hospital Antwerp

Edegem, Antwerp, Belgium, 2650

Actively Recruiting

2

AZ Delta

Roeselare, West Vlaanderen, Belgium, 8800

Not Yet Recruiting

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Research Team

S

Sébastien Anguille, Prof. Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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