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Leukemia

Clofarabine, Cytarabine, and G-CSF for Newly Diagnosed Acute Myeloid Leukemia or Advanced MDS (7144)
Phase 2 Study Of Clofarabine With High Dose Cytarabine And G-CSF Priming In Adult Patients Under Age 60 With Newly Diagnosed Acute Myeloid Leukemia Or Advanced Myelodysplastic Syndrome
Status Conditions Phase Study ID
Closed Acute Myeloid Leukemia (AML) Myelodysplastic Syndrome (MDS) Phase II 7144
NCT01101880
Summary

RATIONALE: 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 G-CSF, 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. Giving clofarabine and cytarabine together with G-CSF may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving clofarabine and cytarabine together with G-CSF works in treating patients with newly diagnosed acute myeloid leukemia or advanced myelodysplastic syndrome.


Investigator
Pamela Becker, MD, PhD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion

  • Diagnosis of acute myeloid leukemia by WHO criteria (except acute promyelocytic leukemia), or myelodysplastic syndrome with >= 10% blasts, RAEB-2 by WHO classification
  • ECOG Performance Status 0 - 2
  • Adequate renal and hepatic function as indicated by the following laboratory values:
  • 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)
  • Aspartate transaminase (AST) =< 2.5 x ULN
  • Alanine transaminase (ALT) =< 2.5 x ULN
  • 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 6 months after study treatment

Exclusion

  • 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 anti-leukemia therapy other than hydroxyurea
  • 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 following: 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
  • Prior allogeneic stem cell transplant
  • No concomitant cytotoxic therapy or investigational therapy is allowed during the study
Last Updated
May 02, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.