Study of Clofarabine in Combination With Low Dose Cytarabine to Treat Myelodysplastic Syndromes (CLO2009AISSM05)

Fondazione Italiana Sindromi Mielodisplastiche-ETS

Status and phase

Withdrawn

Phase 2

Conditions

Myelodysplastic Syndromes

Treatments

Drug: Clofarabine plus low dose Ara-C

Study type

Interventional

Funder types

Other

Identifiers

NCT01302106

CLO2009AISSM05

EudraCT number 2009-012755-23

Details and patient eligibility

About

This is an interventional, multicenter, open label, phase II study designed to evaluate the safety and efficacy of Clofarabine in combination with low dose Cytarabine in untreated patients with poor risk of Myelodisplastic Syndromes.

Sex

All

Ages

55 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female patients age 55 to 80 years
Written informed consent to participate in the clinical trial
Morphologically confirmed diagnosis of MDS according to WHO classification, and IPSS INT-2 or high risk according to IPSS index
ECOG performance status 0-2
No previous chemotherapy
Serum bilirubin ≤1.5 times upper limit of normal (ULN) (unless elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis, but not to liver dysfunction)
AST and ALT ≤2.5 times ULN
Alkaline phosphatase ≤2.5 times ULN
Serum creatinine ≤ 1 mg/dl: if serum creatinine > 1.0 mg/dl, then the estimated glomerular filtration rate (GFR) must be >60 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation where Predicted GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine) -1.154 x age in years -0-023 x 0.742 (if patient is female) x 1.212 (if patient is black)
HIV negative

Exclusion criteria

Have had any other chemotherapy or any investigational therapy as a treatment for MDS. Patients who received chemotherapy for other cancers than MDS/AML can be enrolled, provided that at least 6 months elapsed from accomplishment of the last course of chemo.
Have had a prior hematopoietic stem cell transplant for MDS
Have an uncontrolled systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
Have a psychiatric disorder that would interfere with consent, study participation, or follow-up.
Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart
Have had any prior treatment with Clofarabine
Have had a diagnosis of another malignancy, unless the patient has been disease-free for at least 3 years following the completion of curative intent therapy with the following exceptions: a.)Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease -free duration, are eligible for this study if definitive treatment for the condition has been completed. b.)Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed.
Have prior positive test for the Human Immunodeficiency Virus (HIV), HCV, HBV.