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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01302106
Recruitment Status : Withdrawn (For increased induction mortality in older patients due to specific combinations of drugs, other clinical factors such as patient age and comorbidities.)
First Posted : February 23, 2011
Last Update Posted : October 1, 2013
Sponsor:
Information provided by (Responsible Party):
Fondazione Italiana Sindromi Mielodisplastiche Onlus

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.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Drug: Clofarabine plus low dose Ara-C Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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 the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. To assess the remission rate according to the combination regimen [ Time Frame: 19 months ]

Secondary Outcome Measures :
  1. Duration of response and survival [ Time Frame: 19 months ]
  2. Time to transformation in AML [ Time Frame: 19 months ]
  3. To determine the relationship of cytogenetic abnormalities and response to treatment [ Time Frame: 19 months ]
  4. To determine the safety and tolerability of the combination regimen [ Time Frame: 19 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01302106


Locations
Show Show 21 study locations
Sponsors and Collaborators
Fondazione Italiana Sindromi Mielodisplastiche Onlus
Investigators
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Study Chair: Felicetto Ferrara, MD Division of Hematology and Stem Cell Transplantation Unit, Ospedale "A.Cardarelli", Napoli, Italy
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Responsible Party: Fondazione Italiana Sindromi Mielodisplastiche Onlus
ClinicalTrials.gov Identifier: NCT01302106    
Other Study ID Numbers: CLO2009AISSM05
EudraCT number 2009-012755-23
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: October 1, 2013
Last Verified: September 2013
Keywords provided by Fondazione Italiana Sindromi Mielodisplastiche Onlus:
Myelodysplastic Syndromes
Clofarabine
Low Dose Cytarabine
Poor risk MDS
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Clofarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents