A study of SGI-110 in people with Myelodysplastic syndrome high and Int-2, acute myeloid leukemia = 30% marrow blasts and chronic monocytic leukemia (CMML) type 2
- Conditions
- Myelodysplastic syndrome high and Int-2, acute myeloid leukemia = 30% marrow blasts and chronic monocytic leukemia (CMML) type 2MedDRA version: 16.1Level: HLTClassification code 10028536Term: Myelodysplastic syndromesSystem Organ Class: 100000004851Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2014-000098-38-FR
- Lead Sponsor
- Groupe Francophone des Myélodysplasies (GFM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 54
1. Myelodysplastic syndrome including the following categories of the WHO classification: refractory anemia with excess blasts (RAEB), non-proliferative chronic myelomonocytic leukemia (CMML) (leukocytes < 13 G/L but > 10% marrow blasts), AML with 20-30% marrow blasts (RAEB-T according to the FAB classification), at screening time.
2. Prior treatment with azacitidine or decitabine for at least 6 courses without response
(CR, PR, marrow CR or stable disease with HI according to IWG 2006 criteria) or relapsing after a response. Non responders will be eligible only in the absence of overt progression, ie AML progression (if patients had no AML at onset of azacitidine/decitabine) or doubling of marrow blast percentage between onset of azacitidine/decitabine and screening
3. IPSS score >1 (IPSS: Int-2 or High).
4. Age = 18 years.
5. Normal liver function, defined by total bilirubin and transaminases less than 1.5 times the upper limit of normal.
6. Normal renal function, defined by creatinine less than 1.5 times the upper limit of normal, creatinine clearance = 50 mL/min (according to MDRD formula rather than Cockroft formula in patients older than 65 years) .
7. Patient is known not to be refractory to platelet transfusions.
8. Written informed consent.
9. Patient must understand and voluntarily sign consent form.
10. Patient must be able to adhere to the visit schedule as outlined in the study and follow protocol requirements.
11. ECOG performance status between 0-2 at the time of screening.
12. Women of childbearing potential must: Agree to use effective contraception without interruption throughout the study and for a further 2 months after the end of treatment.
13. 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 2 month after the end of treatment if their partner is of childbearing potential.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54
1. Severe infection or any other uncontrolled severe condition.
2. Significant cardiac disease - NYHA Class III or IV or having suffered a myocardial infarction in the last 6 months.
3. Less than 30 days since prior treatment with growth factors (EPO, G-CSF).
4. 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.
5. 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.
6. Patient already enrolled in another therapeutic trial of an investigational drug.
7. HIV infection or active hepatitis B or C.
8. Women who are or could become pregnant or who are currently breastfeeding.
9. Any medical or psychiatric contraindication that would prevent the patient from understanding and signing the informed consent form.
10. Patient eligible for allotransplantation.
11. Known allergy to SGI-110 or any of its excipients.
12. No affiliation to an insurance system.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method