Status:
TERMINATED
GFM-Acadesine: A Phase I-II Trial of Acadesine
Lead Sponsor:
Groupe Francophone des Myelodysplasies
Collaborating Sponsors:
Advancell - Advanced In Vitro Cell Technologies, S.A.
Conditions:
SMD
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
A phase I-II trial of Acadesine in IPSS high and int 2 myelodysplastic syndromes, acute myeloid leukemia with 20-30% marrow blasts and chronic myelomonocytic leukemia type 2 not responding to Azacitid...
Detailed Description
Primary objectives 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...
Eligibility Criteria
Inclusion
- Myelodysplastic syndrome including the following WHO categories: refractory anemia with excess blasts (RAEB), non-proliferative chronic myelomonocytic leukemia (CMML) (leukocytes \< 13 G/L but \> 10% marrow blasts), WHO- AML with 20-30% marrow blasts (RAEB-T according to the FAB classification)
- 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
- Severe infection or any other uncontrolled severe condition
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01813838
Start Date
June 1 2013
End Date
June 1 2015
Last Update
November 8 2016
Active Locations (17)
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1
Centre hospitalier de la côte Basque
Bayonne, France, 64100
2
Hôpital Avicenne
Bobigny, France, 93009
3
CHU de Haut-Lévèque
Bordeaux Pessac, France, 33604
4
Centre henri Mondor
Créteil, France, 94010