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A Phase II Trial of Clofarabine and Cytarabine to Treat Minimal Residual Disease (MRD) in Acute Myeloid Leukemia


Phase 2
18 Years
75 Years
Not Enrolling
Both
Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Recurrent Adult Acute Myeloid Leukemia

Thank you

Trial Information

A Phase II Trial of Clofarabine and Cytarabine to Treat Minimal Residual Disease (MRD) in Acute Myeloid Leukemia


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Minimal residual disease as assessed by bone marrow flow cytometry, fluorescence in situ hybridization (FISH), and polymerase chain reaction (PCR)

Outcome Time Frame:

At baseline and up to 6 months after treatment

Safety Issue:

No

Principal Investigator

Pamela Becker

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Institutional Review Board

Study ID:

6858

NCT ID:

NCT00863434

Start Date:

February 2009

Completion Date:

Related Keywords:

  • Adult Acute Myeloid Leukemia in Remission
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Recurrent Adult Acute Myeloid Leukemia
  • Congenital Abnormalities
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Neoplasm, Residual

Name

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109