Brief Title
Clofarabine and Cytarabine in Treating Patients With Acute Myeloid Leukemia With Minimal Residual Disease
Official Title
A Phase II Trial of Clofarabine and Cytarabine to Treat Minimal Residual Disease (MRD) in Acute Myeloid Leukemia
Brief 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 clofarabine together with cytarabine may kill more cancer cells.
PURPOSE: This pilot phase II trial is studying how well giving clofarabine together with
cytarabine works in treating patients with acute myeloid leukemia with minimal residual
disease
Detailed Description
PRIMARY OBJECTIVES:
I. To test the ability of clofarabine + ara-C (cytarabine) to eliminate minimal residual
(MRD) in acute myeloid leukemia (AML) patients whose bone marrows exhibit complete remission
by morphology.
SECONDARY OBJECTIVES:
I. To determine the duration of complete remission after this treatment to minimize MRD.
OUTLINE:
Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily (QD) on days 1-5 and
clofarabine intravenously (IV) over 1 hour and cytarabine IV on days 2-5. Beginning
approximately 1 month later, patients may receive one additional course of treatment in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, and
then annually for 3 years.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Minimal Residual Disease as Assessed by Bone Marrow Flow Cytometry
Condition
Adult Acute Myeloid Leukemia in Remission
Intervention
clofarabine
Study Arms / Comparison Groups
Treatment (colony stimulating factor and chemotherapy)
Description: Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
2
Start Date
February 2009
Primary Completion Date
February 2011
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of AML by World Health Organization (WHO) criteria
- Persistence of MRD by flow cytometry (phenotypic blast population detectable at >=
0.1% by flow cytometry despite < 5% blasts by morphology) after initial induction and
one to four cycles of cytarabine containing consolidation chemotherapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 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/1.73m^2 as calculated by the
Modification of Diet in Renal Disease equation, as reported by University of
Washington Medical Center (UWMC) laboratory system
- Serum bilirubin =< 1.5 x upper limit of normal (ULN)
- Aspartate transaminase (AST)/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 Criteria:
- Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as
specified in the protocol
- Use of investigational agents within 30 days or any anticancer therapy within 2 weeks
before study entry, with exceptions for oral agents such as FMS-like tyrosine kinase 3
(Flt3) Inhibitors or hydroxyurea which will be discontinued prior to the
investigational drug regimen; intrathecal treatment within two weeks will also be
allowed but not permitted to be given concurrently with investigational regimen
- The patient must have recovered from all acute non-hematological toxicities from any
previous therapy
- 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 a systemic fungal, bacterial, viral, or other infection not controlled
(defined as exhibiting ongoing signs/symptoms related to the infection and without
improvement, despite appropriate antibiotics or other treatment)
- 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:
- 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
- Prior treatment with clofarabine
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Pamela Becker, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00863434
Organization ID
6858
Secondary IDs
NCI-2009-01666
Responsible Party
Principal Investigator
Study Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Pamela Becker, Principal Investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Verification Date
May 2017