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

NCT01302106 | Withdrawn Phase 2

• 2 other identifiers: CLO2009AISSM05EudraCT number 2009-012755-23
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 21

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

Outcome Measures

Primary Outcomes (1)

• To assess the remission rate according to the combination regimen

  19 months

Secondary Outcomes (4)

• Duration of response and survival

  19 months

• 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

Study Arms (1)

Arm 1

EXPERIMENTAL

Clofarabine combined with low dose Ara-C

Drug: Clofarabine plus low dose Ara-C

Interventions

Clofarabine plus low dose Ara-C 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.

Arm 1

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Italiana Sindromi Mielodisplastiche-ETS: lead

Study Sites (21)

SC Ematologia-AO SS.Antonio e Biagio e Cesare Arrigo

Alessandria, 15121, Italy

Location

Dipartimento Scienze Mediche e Chirurgiche-Ospedale di Torrette

Ancona, 60020, Italy

Location

Ematologia con trapianto-AO Policlinico Bari

Bari, 70124, Italy

Location

SC di Ematologia-Spedali Civili

Brescia, 25123, Italy

Location

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

Campobasso, 86100, Italy

Location

Ematologia e Trapianto di Midollo Osseo-Ospedale Ferrarotto Alessi

Catania, 95123, Italy

Location

Dipartimento di medicina Interna-Università di genova

Genova, 16132, Italy

Location

UO Ematologia Vito Fazzi

Lecce, 73100, Italy

Location

SC Ematologia-Azienda Ospedaliero Papardo

Messina, 98158, Italy

Location

UO Ematologia-Ospedale San gennaro-ASL1

Napoli, 80131, Italy

Location

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

Napoli, Italy

Location

Medicina interna II- Azienda Ospedaliera S.Luigi Gonzaga

Orbassano, 10043, Italy

Location

Divisione di Ematologia-Ospedale Vincenzo Cervello

Palermo, 90146, Italy

Location

Dipartimento di Ematologia-Ospedale Spirito Santo Pescara

Pescara, 65100, Italy

Location

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

Pisa, 56100, Italy

Location

Divisione Ematologia- AO Bianchi Melacrino Morelli

Reggio Calabria, 89100, Italy

Location

UO Ematologia e Trapianto Cellule Staminali, IRCCS, Centro di Riferimento Oncologico della Basilicata

Rionero in Vulture, 85028, Italy

Location

Ematologia-Azienda Ospedaliera Sant'Andrea

Roma, 00189, Italy

Location

Divisione di Ematologia, Centro Trapianto di cellule staminali-IRCCS "Casa Sollievo della Sofferenza"

San Giovanni Rotondo, 71013, Italy

Location

UO Ematologia 2-Ospedale San Giovanni Battista

Torino, 10126, Italy

Location

Divisione di Ematologia-Ospedale Cardinale Panico

Tricase, 73039, Italy

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Clofarabine; Cytarabine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Nucleotides; Ribonucleotides; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Felicetto Ferrara, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2010
• First Posted: February 23, 2011
• Last Updated: October 1, 2013

Record last verified: 2013-09

Locations

IT (21)