Study of Clofarabine in Combination With Low Dose Cytarabine to Treat Myelodysplastic Syndromes
- Conditions
- Myelodysplastic Syndromes
- Interventions
- Registration Number
- NCT01302106
- Lead Sponsor
- Fondazione Italiana Sindromi Mielodisplastiche-ETS
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Clofarabine plus low dose Ara-C Clofarabine combined with low dose Ara-C
- Primary Outcome Measures
Name Time Method To assess the remission rate according to the combination regimen 19 months
- Secondary Outcome Measures
Name Time Method Time to transformation in AML 19 months To determine the relationship of cytogenetic abnormalities and response to treatment 19 months To determine the safety and tolerability of the combination regimen 19 months Duration of response and survival 19 months
Trial Locations
- Locations (21)
SC di Ematologia-Spedali Civili
🇮🇹Brescia, Italy
Dipartimento di medicina Interna-Università di genova
🇮🇹Genova, Italy
SC Ematologia-AO SS.Antonio e Biagio e Cesare Arrigo
🇮🇹Alessandria, Italy
Dipartimento Scienze Mediche e Chirurgiche-Ospedale di Torrette
🇮🇹Ancona, Italy
Ematologia con trapianto-AO Policlinico Bari
🇮🇹Bari, Italy
Ematologia e Trapianto di Midollo Osseo-Ospedale Ferrarotto Alessi
🇮🇹Catania, Italy
UO Ematologia Vito Fazzi
🇮🇹Lecce, Italy
SC Ematologia-Azienda Ospedaliero Papardo
🇮🇹Messina, Italy
Ematologia-Azienda Ospedaliera Sant'Andrea
🇮🇹Roma, Italy
Medicina interna II- Azienda Ospedaliera S.Luigi Gonzaga
🇮🇹Orbassano, Italy
Dipartimento di Ematologia-Ospedale Spirito Santo Pescara
🇮🇹Pescara, Italy
Divisione di Ematologia- Azienda Ospedaliera Pisana Ospedale "S.Chiara"
🇮🇹Pisa, Italy
Divisione di Ematologia-Ospedale Vincenzo Cervello
🇮🇹Palermo, Italy
Divisione di Ematologia, Centro Trapianto di cellule staminali-IRCCS "Casa Sollievo della Sofferenza"
🇮🇹San Giovanni Rotondo, Italy
UO Ematologia 2-Ospedale San Giovanni Battista
🇮🇹Torino, Italy
Divisione Ematologia- AO Bianchi Melacrino Morelli
🇮🇹Reggio Calabria, Italy
UO Ematologia e Trapianto Cellule Staminali, IRCCS, Centro di Riferimento Oncologico della Basilicata
🇮🇹Rionero in Vulture, Italy
Divisione di Ematologia-Ospedale Cardinale Panico
🇮🇹Tricase, Italy
UO Ematologia-Ospedale San gennaro-ASL1
🇮🇹Napoli, Italy
Divisione di Ematologia e Trapianto Cellule Staminali-Ospedale A.Cardelli
🇮🇹Napoli, Italy
centro di ricerca e di formazione ad alta tecnologia nelle Scienze-Università Cattolica Campobasso
🇮🇹Campobasso, Italy