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

This study has been withdrawn prior to enrollment.
(For increased induction mortality in older patients due to specific combinations of drugs, other clinical factors such as patient age and comorbidities.)
Sponsor:
Information provided by (Responsible Party):
Fondazione Italiana Sindromi Mielodisplastiche Onlus
ClinicalTrials.gov Identifier:
NCT01302106
First received: December 22, 2010
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Myelodysplastic Syndromes
Drug: Clofarabine plus low dose Ara-C
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Clofarabine in Combination With Low Dose Cytarabine for Untreated Patients With Poor Risk Myelodysplastic Syndromes

Resource links provided by NLM:


Further study details as provided by Fondazione Italiana Sindromi Mielodisplastiche Onlus:

Primary Outcome Measures:
  • To assess the remission rate according to the combination regimen [ Time Frame: 19 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of response and survival [ Time Frame: 19 months ] [ Designated as safety issue: Yes ]
  • Time to transformation in AML [ Time Frame: 19 months ] [ Designated as safety issue: Yes ]
  • To determine the relationship of cytogenetic abnormalities and response to treatment [ Time Frame: 19 months ] [ Designated as safety issue: Yes ]
  • To determine the safety and tolerability of the combination regimen [ Time Frame: 19 months ] [ Designated as safety issue: Yes ]

Enrollment: 0
Arms Assigned Interventions
Experimental: Arm 1
Clofarabine combined with low dose Ara-C
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.

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302106

Locations
Italy
SC Ematologia-AO SS.Antonio e Biagio e Cesare Arrigo
Alessandria, Italy, 15121
Dipartimento Scienze Mediche e Chirurgiche-Ospedale di Torrette
Ancona, Italy, 60020
Ematologia con trapianto-AO Policlinico Bari
Bari, Italy, 70124
SC di Ematologia-Spedali Civili
Brescia, Italy, 25123
centro di ricerca e di formazione ad alta tecnologia nelle Scienze-Università Cattolica Campobasso
Campobasso, Italy, 86100
Ematologia e Trapianto di Midollo Osseo-Ospedale Ferrarotto Alessi
Catania, Italy, 95123
Dipartimento di medicina Interna-Università di genova
Genova, Italy, 16132
UO Ematologia Vito Fazzi
Lecce, Italy, 73100
SC Ematologia-Azienda Ospedaliero Papardo
Messina, Italy, 98158
UO Ematologia-Ospedale San gennaro-ASL1
Napoli, Italy, 80131
Divisione di Ematologia e Trapianto Cellule Staminali-Ospedale A.Cardelli
Napoli, Italy
Medicina interna II- Azienda Ospedaliera S.Luigi Gonzaga
Orbassano, Italy, 10043
Divisione di Ematologia-Ospedale Vincenzo Cervello
Palermo, Italy, 90146
Dipartimento di Ematologia-Ospedale Spirito Santo Pescara
Pescara, Italy, 65100
Divisione di Ematologia- Azienda Ospedaliera Pisana Ospedale "S.Chiara"
Pisa, Italy, 56100
Divisione Ematologia- AO Bianchi Melacrino Morelli
Reggio Calabria, Italy, 89100
UO Ematologia e Trapianto Cellule Staminali, IRCCS, Centro di Riferimento Oncologico della Basilicata
Rionero in Vulture, Italy, 85028
Ematologia-Azienda Ospedaliera Sant'Andrea
Roma, Italy, 00189
Divisione di Ematologia, Centro Trapianto di cellule staminali-IRCCS "Casa Sollievo della Sofferenza"
San Giovanni Rotondo, Italy, 71013
UO Ematologia 2-Ospedale San Giovanni Battista
Torino, Italy, 10126
Divisione di Ematologia-Ospedale Cardinale Panico
Tricase, Italy, 73039
Sponsors and Collaborators
Fondazione Italiana Sindromi Mielodisplastiche Onlus
Investigators
Study Chair: Felicetto Ferrara, MD Division of Hematology and Stem Cell Transplantation Unit, Ospedale "A.Cardarelli", Napoli, Italy
  More Information

No publications provided

Responsible Party: Fondazione Italiana Sindromi Mielodisplastiche Onlus
ClinicalTrials.gov Identifier: NCT01302106     History of Changes
Other Study ID Numbers: CLO2009AISSM05, EudraCT number 2009-012755-23
Study First Received: December 22, 2010
Last Updated: September 30, 2013
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Fondazione Italiana Sindromi Mielodisplastiche Onlus:
Myelodysplastic Syndromes
Clofarabine
Low Dose Cytarabine
Poor risk MDS

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Syndrome
Bone Marrow Diseases
Disease
Hematologic Diseases
Neoplasms
Pathologic Processes
Precancerous Conditions
Clofarabine
Cytarabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014