Clinical trial NCT01302106: Study of Clofarabine in Combination With Low Dose Cytarabine to Treat Myelodysplastic Syndromes
Official title: Phase II Study of Clofarabine in Combination With Low Dose Cytarabine for Untreated Patients With Poor Risk Myelodysplastic Syndromes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Myelodysplastic Syndromes
Keywords: Myelodysplastic Syndromes
Clofarabine
Low Dose Cytarabine
Poor risk MDS
Lead sponsor: Fondazione Italiana Sindromi Mielodisplastiche-ETS
Sponsor class: OTHER
First posted: 2011-02-23
Enrollment: 0
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: To assess the remission rate according to the combination regimen
timeFrame: 19 months
Secondary outcomes:
measure: Duration of response and survival
timeFrame: 19 months
measure: Time to transformation in AML
timeFrame: 19 months
measure: To determine the relationship of cytogenetic abnormalities and response to treatment
timeFrame: 19 months
measure: To determine the safety and tolerability of the combination regimen
timeFrame: 19 months
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: SC Ematologia-AO SS.Antonio e Biagio e Cesare Arrigo
city: Ancona
country: Italy
facility: Dipartimento Scienze Mediche e Chirurgiche-Ospedale di Torrette
city: Bari
country: Italy
facility: Ematologia con trapianto-AO Policlinico Bari
city: Brescia
country: Italy
facility: SC di Ematologia-Spedali Civili
city: Campobasso
country: Italy
facility: centro di ricerca e di formazione ad alta tecnologia nelle Scienze-Università Cattolica Campobasso
city: Catania
country: Italy
facility: Ematologia e Trapianto di Midollo Osseo-Ospedale Ferrarotto Alessi
city: Genova
country: Italy
facility: Dipartimento di medicina Interna-Università di genova
city: Lecce
country: Italy
facility: UO Ematologia Vito Fazzi
city: Messina
country: Italy
facility: SC Ematologia-Azienda Ospedaliero Papardo
city: Napoli
country: Italy
facility: UO Ematologia-Ospedale San gennaro-ASL1
city: Napoli
country: Italy
facility: Divisione di Ematologia e Trapianto Cellule Staminali-Ospedale A.Cardelli
city: Orbassano
country: Italy
facility: Medicina interna II- Azienda Ospedaliera S.Luigi Gonzaga
city: Palermo
country: Italy
facility: Divisione di Ematologia-Ospedale Vincenzo Cervello
city: Pescara
country: Italy
facility: Dipartimento di Ematologia-Ospedale Spirito Santo Pescara
city: Pisa
country: Italy
facility: Divisione di Ematologia- Azienda Ospedaliera Pisana Ospedale "S.Chiara"
city: Reggio Calabria
country: Italy
facility: Divisione Ematologia- AO Bianchi Melacrino Morelli
city: Rionero in Vulture
country: Italy
facility: UO Ematologia e Trapianto Cellule Staminali, IRCCS, Centro di Riferimento Oncologico della Basilicata
city: Roma
country: Italy
facility: Ematologia-Azienda Ospedaliera Sant'Andrea
city: San Giovanni Rotondo
country: Italy
facility: Divisione di Ematologia, Centro Trapianto di cellule staminali-IRCCS "Casa Sollievo della Sofferenza"
city: Torino
country: Italy
facility: UO Ematologia 2-Ospedale San Giovanni Battista
city: Tricase
country: Italy
facility: Divisione di Ematologia-Ospedale Cardinale Panico
Study officials:
affiliation: Division of Hematology and Stem Cell Transplantation Unit, Ospedale "A.Cardarelli", Napoli, Italy
name: Felicetto Ferrara, MD
role: STUDY_CHAIR
References: