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

NCT ID: NCT01302106

Last Updated: 2013-10-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL

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.

Conditions

Myelodysplastic Syndromes

Keywords

Myelodysplastic Syndromes; Clofarabine; Low Dose Cytarabine; Poor risk MDS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Clofarabine combined with low dose Ara-C

Group Type: EXPERIMENTAL

Clofarabine plus low dose Ara-C

Intervention Type: DRUG

Clofarabine 10 mg/m2 by a 1-hr i.v infusion, once daily, from day 1 to 5. Ara-C 10 mg/m2, subcutaneously, twice a day (q12 hrs), from day 1 to 15. Clofarabine will be given 4 hours before the 2nd dose of Ara-C.

Interventions

Clofarabine plus low dose Ara-C

Clofarabine 10 mg/m2 by a 1-hr i.v infusion, once daily, from day 1 to 5. Ara-C 10 mg/m2, subcutaneously, twice a day (q12 hrs), from day 1 to 15. Clofarabine will be given 4 hours before the 2nd dose of Ara-C.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Italiana Sindromi Mielodisplastiche-ETS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Felicetto Ferrara, MD

Role: STUDY_CHAIR

Division of Hematology and Stem Cell Transplantation Unit, Ospedale "A.Cardarelli", Napoli, Italy

Locations

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

SC di Ematologia-Spedali Civili

Brescia, , Italy

centro di ricerca e di formazione ad alta tecnologia nelle Scienze-Università Cattolica Campobasso

Campobasso, , Italy

Ematologia e Trapianto di Midollo Osseo-Ospedale Ferrarotto Alessi

Catania, , Italy

Dipartimento di medicina Interna-Università di genova

Genova, , Italy

UO Ematologia Vito Fazzi

Lecce, , Italy

SC Ematologia-Azienda Ospedaliero Papardo

Messina, , Italy

UO Ematologia-Ospedale San gennaro-ASL1

Napoli, , Italy

Divisione di Ematologia e Trapianto Cellule Staminali-Ospedale A.Cardelli

Napoli, , Italy

Medicina interna II- Azienda Ospedaliera S.Luigi Gonzaga

Orbassano, , Italy

Divisione di Ematologia-Ospedale Vincenzo Cervello

Palermo, , Italy

Dipartimento di Ematologia-Ospedale Spirito Santo Pescara

Pescara, , Italy

Divisione di Ematologia- Azienda Ospedaliera Pisana Ospedale "S.Chiara"

Pisa, , 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

Ematologia-Azienda Ospedaliera Sant'Andrea

Roma, , 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 di Ematologia-Ospedale Cardinale Panico

Tricase, , Italy

Countries

Italy

Other Identifiers

EudraCT number 2009-012755-23

Identifier Type: -

Identifier Source: secondary_id

CLO2009AISSM05

Identifier Type: -

Identifier Source: org_study_id