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Phase 2 Study Of Clofarabine With High Dose Cytarabine And G-CSF Priming In Adult Patients Less Than Age 65 With Newly Diagnosed Acute Myeloid Leukemia Or Advanced Myelodysplastic Syndrome and/or Advanced Myeloproliferative Neoplasm


Phase 2
18 Years
64 Years
Open (Enrolling)
Both
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), 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), Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndromes, Refractory Anemia With Excess Blasts, Untreated Adult Acute Myeloid Leukemia, Myeloproliferative Neoplasm With 10% Blasts or Higher

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Trial Information

Phase 2 Study Of Clofarabine With High Dose Cytarabine And G-CSF Priming In Adult Patients Less Than Age 65 With Newly Diagnosed Acute Myeloid Leukemia Or Advanced Myelodysplastic Syndrome and/or Advanced Myeloproliferative Neoplasm


PRIMARY OBJECTIVES:

I. To assess the complete remission (CR) rate of this regimen as compared with 7 + 3
standard induction with the 90 mg/m^2/dose of daunorubicin (historical control) in
previously untreated patients with AML or advanced MDS or advanced myeloproliferative
neoplasm less than age 65.

SECONDARY OBJECTIVES:

I. To determine the event free survival (EFS), overall survival (OS) and treatment related
mortality of this regimen.

II. To assess the toxicity of this regimen in previously untreated patients. III. To
determine whether 3 consolidation chemotherapy cycles consisting of G-CSF (filgrastim),
clofarabine, and cytarabine (GCLAC) can be administered with prompt recovery of blood
counts.

OUTLINE:

INDUCTION THERAPY: Patients receive filgrastim subcutaneously (SC) daily beginning the day
prior to chemotherapy and continuing until blood counts recover. Patients receive
clofarabine intravenously (IV) over 1 hour followed by cytarabine IV over 2 hours daily for
5 days.

CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day
prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV
over 2 hours daily for 4 days.

Treatment with induction therapy may continue for up to 2 courses and treatment with
consolidation therapy may continue for up to 3 courses 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 5 years.


Inclusion Criteria:



- Diagnosis of acute myeloid leukemia by World Health Organization (WHO) criteria
(except acute promyelocytic leukemia), or myelodysplastic syndrome, RAEB-2 by WHO
classification or advanced myeloproliferative neoplasm with >= 10% blasts in the bone
marrow or peripheral blood, including chronic myelomonocytic leukemia (CMML)-2 by WHO
classification

- Eastern Cooperative Oncology Group (ECOG) Performance Status 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/1.73 m^2 as calculated by the
Modification of Diet in Renal Disease equation

- Serum bilirubin =< 1.5 x upper limit of normal (ULN) unless elevation is thought to
be due to Gilbert's syndrome, hemolysis, or hepatic infiltration by the hematologic
malignancy

- Aspartate transferase (AST)/alanine transferase (ALT) =< 2.5 x ULN unless elevation
is thought to be due to hepatic infiltration by the hematologic malignancy

- 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 90 days after study treatment

Exclusion Criteria:

- 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 induction chemotherapy for AML; treatment with hydroxyurea is permitted;
treatment with imides or hypomethylating agents for preceding hematological disorders
is permitted

- 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:

- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Rates of complete remission and complete remission with incomplete recovery of counts

Outcome Description:

With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates.

Outcome Time Frame:

Up to 5 years

Safety Issue:

Yes

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:

7144

NCT ID:

NCT01101880

Start Date:

August 2010

Completion Date:

Related Keywords:

  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Del(5q)
  • 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)
  • Chronic Myelomonocytic Leukemia
  • de Novo Myelodysplastic Syndromes
  • Refractory Anemia With Excess Blasts
  • Untreated Adult Acute Myeloid Leukemia
  • Myeloproliferative Neoplasm With 10% Blasts or Higher
  • Congenital Abnormalities
  • Anemia
  • Anemia, Refractory
  • Anemia, Refractory, with Excess of Blasts
  • Neoplasms
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelomonocytic, Chronic
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Acute
  • Myeloproliferative Disorders

Name

Location

Stanford UniversityStanford, California  94305
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109
City of Hope Medical CenterDuarte, California  91010