Acadesine for patients with relapsed/refractory chronic lymphocytic leukemia (CLL): a multicenter phase I/II study.

Van Den Neste E, Cazin B, Janssens A, González-Barca E, Terol MJ, Levy V, Pérez de Oteyza J, Zachee P, Saunders A, de Frias M, Campàs C

Cancer chemotherapy and pharmacology11 Dec 2012Cited by 45 (Europe PMC)

PMID23228986PMCIDPMC3579463DOI10.1007/s00280-012-2033-5PepBankPUB-23228986

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Summary

PurposeAcadesine has shown in vitro to selectively induce apoptosis in B cells from chronic lymphocytic leukemia (CLL) patients. We conducted a phase I/II open-label clinical study, to determine the safety and tolerability of acadesine given intravenously as a 4-h infusion to CLL patients.MethodsPatient population included CLL patients with relapsed/refractory disease who had received one or more prior lines of treatment including either a fludarabine or an alkylator-based regimen. Twenty-four patients were included: eighteen in Part I treated at single doses of 50-315 mg/kg, and six in Part II, three with two doses at 210 mg/kg and three with five doses at 210 mg/kg.ResultsA manageable and predictable safety profile was demonstrated for acadesine at single doses between 50 and 210 mg/kg; 210 mg/kg was the maximum tolerated dose (MTD) and optimal biological dose (OBD). Grade ≥2 hyperuricemia occurred commonly but was not clinically significant and resolved with the administration of prophylactic allopurinol. Other adverse events included transient anemia and/or thrombocytopenia (not clinically significant), renal impairment, and transient infusion-related hypotension (clinically significant). Trends of efficacy such as a reduction of peripheral CLL cells and reduction in lymphadenopathy were observed; however, the results were variable due to the small population and the range of doses tested.ConclusionsA MTD of 210 mg/kg was established with single acadesine dose. Multiple dose administrations at the OBD were tested with an acceptable safety profile, showing that acadesine might be a valuable agent for the treatment of relapsed/refractory CLL patients.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

01HumanNon-randomized trialSafety outcome
In relapsed/refractory CLL patients, single acadesine doses between 50 and 210 mg/kg showed a manageable and predictable safety profile.
In plain wordsIn patients with previously treated CLL, single acadesine doses between 50 and 210 mg/kg showed a manageable safety profile.
Peptide
AICAR (acadesine)
Outcome
Not applicableSafety profile at single doses
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
50-210 mg/kg · intravenous 4-h infusionAs given in this study (human).
Source sentences
Summary
A manageable and predictable safety profile was demonstrated for acadesine at single doses between 50 and 210 mg/kg; 210 mg/kg was the maximum tolerated dose (MTD) and optimal biological dose (OBD).
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a phase I/II open-label clinical study, to determine the safety and tolerability of acadesine given intravenously as a 4-h infusion to CLL patients.
Summary · context
Patient population included CLL patients with relapsed/refractory disease who had received one or more prior lines of treatment including either a fludarabine or an alkylator-based regimen.
Show in the study text Report a problemFND-2322898601
02HumanNon-randomized trialSafety outcome
In relapsed/refractory CLL patients, acadesine's maximum tolerated dose and optimal biological dose were 210 mg/kg.
In plain wordsIn patients with previously treated CLL, acadesine's maximum tolerated and optimal biological dose was 210 mg/kg.
Peptide
AICAR (acadesine)
Outcome
Not applicableMaximum tolerated and optimal biological dose
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
210 mg/kg · intravenous 4-h infusionAs given in this study (human).
Measurements
Maximum tolerated dose
210 mg/kg
single acadesine dose
Optimal biological dose
210 mg/kg
acadesine
Source sentences
Summary
A manageable and predictable safety profile was demonstrated for acadesine at single doses between 50 and 210 mg/kg; 210 mg/kg was the maximum tolerated dose (MTD) and optimal biological dose (OBD).
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a phase I/II open-label clinical study, to determine the safety and tolerability of acadesine given intravenously as a 4-h infusion to CLL patients.
Summary · context
Patient population included CLL patients with relapsed/refractory disease who had received one or more prior lines of treatment including either a fludarabine or an alkylator-based regimen.
Show in the study text Report a problemFND-2322898602
03HumanNon-randomized trialSafety outcome
In CLL patients receiving acadesine, grade ≥2 hyperuricemia occurred commonly, lacked clinical significance, and resolved with prophylactic allopurinol.
In plain wordsIn patients with CLL receiving acadesine, grade ≥2 high uric acid occurred commonly without clinical significance and resolved with preventive allopurinol.
Peptide
AICAR (acadesine)
Outcome
Not applicableHyperuricemia
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · intravenous 4-h infusionAs given in this study (human).
Source sentences
Summary
Grade ≥2 hyperuricemia occurred commonly but was not clinically significant and resolved with the administration of prophylactic allopurinol.
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a phase I/II open-label clinical study, to determine the safety and tolerability of acadesine given intravenously as a 4-h infusion to CLL patients.
Summary · context
Patient population included CLL patients with relapsed/refractory disease who had received one or more prior lines of treatment including either a fludarabine or an alkylator-based regimen.
Show in the study text Report a problemFND-2322898603
04HumanNon-randomized trialSafety outcome
In CLL patients receiving acadesine, adverse events included transient anemia and/or thrombocytopenia, not clinically significant.
In plain wordsIn patients with CLL, acadesine adverse events included temporary anemia and/or low platelets without clinical significance.
Peptide
AICAR (acadesine)
Outcome
Not applicableTransient anemia and/or thrombocytopenia
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · intravenous 4-h infusionAs given in this study (human).
Source sentences
Summary
Other adverse events included transient anemia and/or thrombocytopenia (not clinically significant), renal impairment, and transient infusion-related hypotension (clinically significant).
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a phase I/II open-label clinical study, to determine the safety and tolerability of acadesine given intravenously as a 4-h infusion to CLL patients.
Summary · context
Patient population included CLL patients with relapsed/refractory disease who had received one or more prior lines of treatment including either a fludarabine or an alkylator-based regimen.
Show in the study text Report a problemFND-2322898604
05HumanNon-randomized trialSafety outcome
In CLL patients receiving acadesine, adverse events included renal impairment.
In plain wordsIn patients with CLL, acadesine adverse events included impaired kidney function.
Peptide
AICAR (acadesine)
Outcome
Not applicableRenal impairment
Study
n: not reported in source
Outcome group
Adverse events · Kidney and urinary
Studied dose
Dose not stated · intravenous 4-h infusionAs given in this study (human).
Source sentences
Summary
Other adverse events included transient anemia and/or thrombocytopenia (not clinically significant), renal impairment, and transient infusion-related hypotension (clinically significant).
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a phase I/II open-label clinical study, to determine the safety and tolerability of acadesine given intravenously as a 4-h infusion to CLL patients.
Summary · context
Patient population included CLL patients with relapsed/refractory disease who had received one or more prior lines of treatment including either a fludarabine or an alkylator-based regimen.
Show in the study text Report a problemFND-2322898606
06HumanNon-randomized trialSafety outcome
In CLL patients receiving acadesine, adverse events included transient, clinically significant infusion-related hypotension.
In plain wordsIn patients with CLL, acadesine adverse events included temporary, clinically significant low blood pressure during infusion.
Peptide
AICAR (acadesine)
Outcome
Not applicableInfusion-related hypotension
Study
n: not reported in source
Outcome group
Adverse events · Cardiovascular
Studied dose
Dose not stated · intravenous 4-h infusionAs given in this study (human).
Source sentences
Summary
Other adverse events included transient anemia and/or thrombocytopenia (not clinically significant), renal impairment, and transient infusion-related hypotension (clinically significant).
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a phase I/II open-label clinical study, to determine the safety and tolerability of acadesine given intravenously as a 4-h infusion to CLL patients.
Summary · context
Patient population included CLL patients with relapsed/refractory disease who had received one or more prior lines of treatment including either a fludarabine or an alkylator-based regimen.
Show in the study text Report a problemFND-2322898607
07HumanNon-randomized trialEfficacy outcome
In CLL patients receiving acadesine, peripheral CLL cells showed a reduction trend, but results varied across the small population and doses.
In plain wordsIn patients with CLL, acadesine showed a trend toward fewer circulating leukemia cells, but results varied.
Peptide
AICAR (acadesine)
Outcome
DecreasePeripheral CLL cells
Study
n: not reported in source
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · intravenous 4-h infusionAs given in this study (human).
Source sentences
Summary
Trends of efficacy such as a reduction of peripheral CLL cells and reduction in lymphadenopathy were observed; however, the results were variable due to the small population and the range of doses tested.
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a phase I/II open-label clinical study, to determine the safety and tolerability of acadesine given intravenously as a 4-h infusion to CLL patients.
Summary · context
Patient population included CLL patients with relapsed/refractory disease who had received one or more prior lines of treatment including either a fludarabine or an alkylator-based regimen.
Show in the study text Report a problemFND-2322898608
08HumanNon-randomized trialEfficacy outcome
In CLL patients receiving acadesine, lymphadenopathy showed a reduction trend, but results varied across the small population and doses.
In plain wordsIn patients with CLL, acadesine showed a trend toward smaller enlarged lymph nodes, but results varied.
Peptide
AICAR (acadesine)
Outcome
DecreaseLymphadenopathy
Study
n: not reported in source
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · intravenous 4-h infusionAs given in this study (human).
Source sentences
Summary
Trends of efficacy such as a reduction of peripheral CLL cells and reduction in lymphadenopathy were observed; however, the results were variable due to the small population and the range of doses tested.
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a phase I/II open-label clinical study, to determine the safety and tolerability of acadesine given intravenously as a 4-h infusion to CLL patients.
Summary · context
Patient population included CLL patients with relapsed/refractory disease who had received one or more prior lines of treatment including either a fludarabine or an alkylator-based regimen.
Show in the study text Report a problemFND-2322898609

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
21 Oct 2026, 15:58 UTC
Study results updated
Version 1
21 Oct 2026, 12:50 UTC
First added · source update from Europe PMC

Subjects

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