Clofarabine, Cytarabine, and Filgrastim in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia, Advanced Myelodysplastic Syndrome, and/or Advanced Myeloproliferative Neoplasm

Not Recruiting

Trial ID: NCT01101880


This phase II trial is studying how well giving clofarabine and cytarabine together with filgrastim works in treating patients with newly diagnosed acute myeloid leukemia (AML), advanced myelodysplastic syndrome (MDS), and/or advanced myeloproliferative neoplasm. Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving the drugs in different doses may kill more cancer cells. Colony stimulating factors, such as filgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy.

Official Title

Phase 2 Study Of Clofarabine With High Dose Cytarabine And G-CSF Priming In Adult Patients Less Than Age 65 With Newly Diagnosed Acute Myeloid Leukemia Or Advanced Myelodysplastic Syndrome and/or Advanced Myeloproliferative Neoplasm

Stanford Investigator(s)

Jason Gotlib

Professor of Medicine (Hematology)


Inclusion Criteria:

   - Diagnosis of acute myeloid leukemia by World Health Organization (WHO) criteria
   (except acute promyelocytic leukemia), or myelodysplastic syndrome, RAEB-2 by WHO
   classification or advanced myeloproliferative neoplasm with >= 10% blasts in the bone
   marrow or peripheral blood, including chronic myelomonocytic leukemia (CMML)-2 by WHO

   - Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2

   - Serum creatinine =< 1.0 mg/dL; if serum creatinine > 1.0 mg/dL, then the estimated
   glomerular filtration rate (GFR) must be > 60 mL/min/1.73 m^2 as calculated by the
   Modification of Diet in Renal Disease equation

   - Serum bilirubin =< 1.5 x upper limit of normal (ULN) unless elevation is thought to be
   due to Gilbert's syndrome, hemolysis, or hepatic infiltration by the hematologic

   - Aspartate transferase (AST)/alanine transferase (ALT) =< 2.5 x ULN unless elevation is
   thought to be due to hepatic infiltration by the hematologic malignancy

   - Alkaline phosphatase =< 2.5 x ULN

   - Capable of understanding the investigational nature, potential risks and benefits of
   the study, and able to provide valid informed consent

   - Female patients of childbearing potential must have a negative serum pregnancy test
   within 2 weeks prior to enrollment

   - Male and female patients must use an effective contraceptive method during the study
   and for a minimum of 90 days after study treatment

Exclusion Criteria:

   - Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as
   specified in the protocol with the exception of intrathecal chemotherapy administered
   on days that are not concurrent with clofarabine and cytarabine

   - No prior induction chemotherapy for AML; treatment with hydroxyurea is permitted;
   treatment with imides or hypomethylating agents for preceding hematological disorders
   is permitted

   - Have any other severe concurrent disease, or have a history of serious organ
   dysfunction or disease involving the heart, kidney, liver, or other organ system that
   may place the patient at undue risk to undergo treatment

   - Patients with significant organ compromise due to systemic fungal, bacterial, viral,
   or other infection

   - Pregnant or lactating patients

   - Any significant concurrent illness, condition, or psychiatric disorder that would
   compromise patient safety or compliance, interfere with consent, study participation,
   follow up, or interpretation of study results

   - 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 including the

      - 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

      - 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

   - Prior allogeneic stem cell transplant


biological: filgrastim

drug: Clofarabine

drug: Cytarabine

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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