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

Phase 2
55 Years
80 Years
Not Enrolling
Myelodysplastic Syndromes

Thank you

Trial Information

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

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.

Type of Study:


Study Design:

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

Outcome Measure:

To assess the remission rate according to the combination regimen

Outcome Time Frame:

19 months

Safety Issue:


Principal Investigator

Felicetto Ferrara, MD

Investigator Role:

Study Chair

Investigator Affiliation:

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


Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study ID:




Start Date:

April 2011

Completion Date:

November 2013

Related Keywords:

  • Myelodysplastic Syndromes
  • Myelodysplastic Syndromes
  • Clofarabine
  • Low Dose Cytarabine
  • Poor risk MDS
  • Myelodysplastic Syndromes
  • Preleukemia