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

Myelodysplastic Syndromes Clinical Trial

— CLO2009AISSM05  

Official title:

Phase II Study of Clofarabine in Combination With Low Dose Cytarabine for Untreated Patients With Poor Risk Myelodysplastic Syndromes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01302106
• Other study ID #: CLO2009AISSM05
• Secondary ID: EudraCT number 2
• Status: Withdrawn
• Phase: Phase 2
• First received: December 22, 2010
• Last updated: September 30, 2013

Study information

• Verified date: September 2013
• Source: Fondazione Italiana Sindromi Mielodisplastiche Onlus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 80 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
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	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	Divisione di Ematologia e Trapianto Cellule Staminali-Ospedale A.Cardelli	Napoli
Italy	UO Ematologia-Ospedale San gennaro-ASL1	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

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Italiana Sindromi Mielodisplastiche Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the remission rate according to the combination regimen		19 months	Yes
Secondary	Duration of response and survival		19 months	Yes
Secondary	Time to transformation in AML		19 months	Yes
Secondary	To determine the relationship of cytogenetic abnormalities and response to treatment		19 months	Yes
Secondary	To determine the safety and tolerability of the combination regimen		19 months	Yes