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Clofarabine, Etoposide, and Mitoxantrone for Relapsed and Refractory Acute Leukemias

Phase 1
18 Years
70 Years
Not Enrolling

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Trial Information

Clofarabine, Etoposide, and Mitoxantrone for Relapsed and Refractory Acute Leukemias

This will be a phase I study with a standard 3x3 design. Patients will proceed to treatment
through a series of cohorts with the three drugs being delivered over five days beginning
with a dose of Etoposide 100 mg/m2 on days 1-5,Mitoxantrone 8 mg/m2 days 1-3, and
clofarabine at 20 mg/m2 IV on days 2-6. Presuming this and subsequent cohorts are tolerable
and no more than 1 patient per cohort develops DLT, MTD patients will be treated in cohorts
of 3-6 patients up to a final dose level of Etoposide 100 mg/m2 on days 1-5,Mitoxantrone 8
mg/m2 days 1-5, and Clofarabine at 30 mg/m2 IV on days 2-6. Patients failing to enter
remission may receive 4 days of therapy with Etoposide 100 mg/m2 on days 1-4,Mitoxantrone 8
mg/m2 days 1-2 or 1-4,and Clofarabine at 20-30 mg/m2 IV on days 1-4. According to
established definitions for dose limiting toxicity a recommended phase II dose will be
established. After this is established the final cohort will be expanded to 15 patients.

Inclusion Criteria:

- Adequate renal and hepatic function.

- 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.

- LVEF must be ≥ 50% within 2 weeks.

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 the exception of hydroxyurea. The patient must have
recovered from all acute 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.

- Any significant concurrent disease, illness, 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 with the
following exceptions: patients with treated non-melanoma skin cancer, in situ
carcinoma or cervical intraepithelial neoplasia, regardless of the disease-free
duration, are eligible for the 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 values are also
eligible for this study if hormonal therapy has been initiated or a radical
prostatectomy has been performed. Additionally, patients with prostate cancer
treated with radiation therapy are also eligible for the study.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Establish toxicity of Clofarabine in combination with Etoposide and Mitoxantrone for therapy of relapsed or refractory acute leukemias

Outcome Time Frame:

Days 30-45

Safety Issue:


Principal Investigator

David F. Claxton, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Penn State College of Medicine


United States: Institutional Review Board

Study ID:

PSHCI 08-096



Start Date:

March 2009

Completion Date:

September 2013

Related Keywords:

  • Leukemia
  • acute lymphoblastic leukemia
  • chronic lymphocytic leukemia
  • Leukemia



Penn State Hershey Cancer InstituteHershey, Pennsylvania  17033