A Study in Leukemia Patients With Karonudib

ConditionLeukemia

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-75

SponsorThomas Helleday Foundation

About this trial

The primary objective of this study is to determine safety and tolerability of Karonudib for the treatment of hematological malignancies.

Secondary objectives are to determine a recommended RP2D and schedule for further development of Karonudib, to determine the pharmacokinetics of Karonudib, to look for evidence of treatment efficacy. Overall survival will also be recorded.

Eligibility criteria

Qualifiers

Written informed consent.

Age 18-75 years (may be extended to older if deemed fit).

The patient has received standard of care treatments and has refractory or relapsed or progressive disease with no suitable standard of care options available.

Expansion cohort (Cohort V): Relapsed, Recurrent or Progressive AML or MDS according to the ELN 2017 criteriaWHO 2016 criteria.

Disqualifiers

Age less than 18 years.

Less than 4 weeks since stopping previous systemic chemotherapy treatment with the exception of stable dose Hydroxyurea, Trophosphamide, oral Cyclophosphamide, ImID or Thioguanine which needs to be stopped 10 x t1/2 prior to Karonudib administration.

Less than 1 week since stopping palliative radiotherapy.

Less than 2 weeks after surgery except access surgical procedures.