Clofarabine and Cytarabine in Treating Patients With Acute Myeloid Leukemia With Minimal Residual Disease

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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