Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1/PHASE2
5 participants
INTERVENTIONAL
2013-06-30
2015-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Patients will receive 6 treatment cycles unless disease progression, transformation, or unacceptable toxicity occurs, or the patient refuses to continue participating in the study.
Efficacy will be assessed at the end of the 2nd, 4th and 6th cycles. After 6 cycles, patients demonstrating a response (CR, PR, marrow CR, or HI) will be able to continue with cycles of Acadesine (at the same dose as in the preceding cycles, depending on their cohort) until progression.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Phase I:
To determine the maximal tolerated dose (MTD) and dose limiting toxicities (DLTs) of increasing doses of IV Acadesine administered on D1, D3, D5, D8, D10 and D12 of 28 to 56 day-courses
Phase II:
To confirm safety and hematological toxicity in 18 additional patients
Secondary objectives:
Phase I:
* To determine response rates, as defined by the 2006 modified IWG criteria,
* To evaluate response duration, time to IPSS progression, and loss of RBC transfusion independence in these patients.
* To evaluate hospitalization duration, rates of rehospitalization for non-hematological toxicities, severe bleeding or febrile neutropenia.
Phase II:
To determine
* response rate as defined by the 2006 modified IWG criteria
* toxicity profile and safety
* response duration
* rate of progression to AML
* overall survival
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ACADESINE 140mg/kg/d
3 patients will be included at the initial dose of Acadesine 140mg/kg/d
ACADESINE 140mg/kg/d
3 patients will be included at the initial dose of 140mg/kg/d. In absence of toxicity, 3 additional patients will be included at the higher dosage.
In case of 1/3 toxicity, 3 additionnal patients will be included at the same dose level, currently 140mg/kg/d.
In case of toxicity in 2 or more patients, the dose of acadesine will be reduced at the the dose of 85mg/kg/d
ACADESINE 210mg/kg/d
In absence of toxicity at the dose of 140mg/kg/d. There is a dose escalation of acadesine at the dose of 210mg/kg/d for 3 additionnal patients
ACADESINE 210mg/kg/d
3 patients will be included at the dose of 210mg/kg/d. In absence of toxicity, 3 additional patients will be included at the higher dosage.
In case of 1/3 toxicity, 3 additionnal patients will be included at the same dose level, currently 210mg/kg/d.
In case of toxicity in 2 or more patients, the dose of acadesine will be reduced at the the dose of 140mg/kg/d
ACADESINE 315mg/kg/d
In absence of toxicity at the dose of 210mg/kg/d. There is a dose escalation of acadesine at the dose of 315mg/kg/d for 3 additionnal patients
ACADESINE 315mg/kg/d
3 patients will be included at the dose of 315mg/kg/d.
In case of 1/3 toxicity, 3 additionnal patients will be included at the same dose level, currently 315mg/kg/d.
In case of toxicity in 2 or more patients, the dose of acadesine will be reduced at the the dose of 210mg/kg/d
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ACADESINE 140mg/kg/d
3 patients will be included at the initial dose of 140mg/kg/d. In absence of toxicity, 3 additional patients will be included at the higher dosage.
In case of 1/3 toxicity, 3 additionnal patients will be included at the same dose level, currently 140mg/kg/d.
In case of toxicity in 2 or more patients, the dose of acadesine will be reduced at the the dose of 85mg/kg/d
ACADESINE 210mg/kg/d
3 patients will be included at the dose of 210mg/kg/d. In absence of toxicity, 3 additional patients will be included at the higher dosage.
In case of 1/3 toxicity, 3 additionnal patients will be included at the same dose level, currently 210mg/kg/d.
In case of toxicity in 2 or more patients, the dose of acadesine will be reduced at the the dose of 140mg/kg/d
ACADESINE 315mg/kg/d
3 patients will be included at the dose of 315mg/kg/d.
In case of 1/3 toxicity, 3 additionnal patients will be included at the same dose level, currently 315mg/kg/d.
In case of toxicity in 2 or more patients, the dose of acadesine will be reduced at the the dose of 210mg/kg/d
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Prior treatment with Azacitidine or Decitabine for at least 6 courses without response (including CR, PR, marrow CR and stable disease with hematological improvement) or relapse after a response
* IPSS score \>1 (IPSS: Int-2 or High);
* Age ≥ 18 years;
* Normal liver function tests, defined by total bilirubin and transaminases less than 1.5 time the upper limit of normal;
* Normal renal function, defined by creatinine less than 1.5 time the upper limit of normal, creatinine clearance ≥ 50 mL/min.
* Patient ineligible for allogeneic hematopoietic stem cell transplantation;
* Written informed consent;
* Patient must understand and voluntarily sign consent form;
* Patient must be able to adhere to the visit schedule as outlined in the study and follow protocol requirements;
* ECOG performance status between 0-2 at the time of screening;
* Women of childbearing potential must:
Agree to use effective contraception without interruption throughout the study and for a further 1 month after the end of treatment;
* Men must:
Agree to not conceive during the treatment and to use effective contraception during the treatment period (including periods of dose reduction or temporary suspension) and for a further 1 month after the end of treatment if their partner is of childbearing potential.
Exclusion Criteria
* Significant cardiac disease - NYHA Class III or IV or having suffered a myocardial infarction in the last 6 months
* Less than 30 days since prior treatment with growth factors (EPO, G-CSF)
* Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea. The patient must have recovered from all acute toxicities from any previous therapy.
* Active cancer, or cancer during the year prior to trial entry other than basal cell carcinoma or carcinoma in situ of the cervix or breast;
* Patient already enrolled in another therapeutic trial of an investigational drug;
* HIV infection or active hepatitis B or C;
* Women who are or could become pregnant or who are currently breastfeeding;
* Any medical or psychiatric contraindication that would prevent the patient from understanding and signing the informed consent form;
* Patient eligible for allotransplantation.
* Known allergy to acadesine or any of its excipients
* No affiliation to an insurance system
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Advancell - Advanced In Vitro Cell Technologies, S.A.
INDUSTRY
Groupe Francophone des Myelodysplasies
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Thomas Cluzeau, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Saint Louis, Paris, France
Pierre Fenaux, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Saint Louis, Paris, France
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre hospitalier de la côte Basque
Bayonne, , France
Hôpital Avicenne
Bobigny, , France
CHU de Haut-Lévèque
Bordeaux Pessac, , France
Centre henri Mondor
Créteil, , France
CHU de Grenoble
Grenoble, , France
CHU de Limoges
Limoges, , France
Institut paoli calmettes
Marseille, , France
centre hospitalier de Meaux
Meaux, , France
CHU de nantes
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
Hôpital L'archet 1, Nice
Nice, , France
Hôpital Saint Louis
Paris, , France
Hôpital Saint Antoine
Paris, , France
Hôpital Saint-Louis
Paris, , France
Hôpital Cochin
Paris, , France
Centre henri Becquerel
Rouen, , France
Hôpital Bretonneau de Tours
Tours, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-003120-21
Identifier Type: -
Identifier Source: org_study_id