Safety and Tolerability Open Label Dose Escalation Study of Acadesine in B-CLL Patients

What Was Tested

The trial (phase 1, phase 2) is built around AICAR.

The main aim of this study is to test the safety of acadesine in patients with B-CLL and see what effects it has on patients and their leukaemia.

The study also aims to examine the way acadesine is processed by the body.

The registry classes the interventions as drug.

More on the Plan

Eligible patients will be enrolled into Part I or Part II of the study in cohorts of three patients.

The OBD will be reviewed by the DMB prior to the start of Part II of the study.

If 1 out of the 3 patients experiences a DLT, a further 3 patients will be recruited to the cohort.

Who Took Part

Enrollment: 40 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosis of B-CLL according to NCI Working Group Criteria. Have an elevated B-cell count of ≥ 5000/mm3. Have a T-cell count ≥ 200/mm3. ECOG Performance Status ≤ 2. Have a life expectancy of at least 3 months.

The full record lists 9 inclusion and 26 exclusion criteria; among the exclusions: patients who, in the opinion of the investigator, need immediate treatment with proven chemotherapy and/or immunotherapy, and/or transplantation; have b-cll with central nervous system involvement; have received chemotherapy or radiotherapy treatment in the 30 days preceding day 1.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when AICAR was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2007-12 with completion listed for 2010-12.

It ran at 8 sites in Belgium (3), Spain (3) and France (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: adverse event and serious adverse events(incidence, causality, severity), local tolerability (including liver enzymes, blood glucose and uric acid) and vital signs (time frame: up to and including Day 22 follow up visit).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of AICAR in 40 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the AICAR compound page, all human trials.