A Phase I/II Multicenter Study of IV Clofarabine In Patients with High-Risk Myelodysplastic Syndrome who have failed Therapy with Azacitidine: the NIDEVOL study - GFM-clo-08
- Conditions
- In Patients with High-Risk Myelodysplastic Syndrome who have failed Therapy with AzacitidineMedDRA version: 9.1Level: LLTClassification code 10028533Term: Myelodysplastic syndrome
- Registration Number
- EUCTR2009-013404-32-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
- Not specified
•Patients aged 18 years or more with MDS according to FAB classification and intermediate-2 or high IPSS risk scores, or CMML (with WBC < 13 x 109/L and bone marrow blasts > 10%) according to WHO classification, or AML according to WHO classification if less than 30% bone marrow blasts (RAEB-T according to FAB MDS classification)
•Patients previously treated by azacitidine (Vidaza®) in proven progression, or stable after 6 courses with ongoing transfusion dependent anemia (> 4 RBC units in the 8 weeks preceding inclusion ( as erythroid response in IWG 2006 criteria is reduction of at least 4 RBC units in 8 weeks )
•Previous biological and or targeted therapies of MDS or AML are allowed if stopped more than 1 month before inclusion.
1.ECOG PS = 2.
2.Adequate renal and liver function
3.Serum creatinine = 110 microM/L in men or 90 microM/L in women. If plasma creatinine level >90- 110microM, then the estimated glomerular filtration rate (GFR) must be > 50 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease (MDRD) equation where Predicted GFR (ml/min/1.73 m2) = 32788x (plasma creatinine level (microM)-1.154 x (age in years)-0.023 x (0.742 if patient is female) x (1.212 if patient is African American)
4.Bilirubin < 1.5 x ULN, (except increased unconjugated bilirubin due to dyserythropoiesis)
5.Aspartate transaminase (AST)/alanine transaminase (ALT) ?2.5 × ULN and Alkaline phosphatase ? 2.5 × ULN
•Absence of pregnancy or lactation in female patients (Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment)
•Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
•Provided signed written informed consent
•Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Patients with AML and bone marrow blasts count of 20-30% , if candidates to intensive AML type chemotherapy
•Known hypersensitivity to clofarabine or excipients
•Concomitant malignant disease.
•Active uncontrolled infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
•Concomitant severe cardiovascular disease, i.e. congestive heart failure (NYHA grade > 3)
•Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
•No affiliation to a national insurance scheme directly or to an equivalent system
•Chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
•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.
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