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Phase II Trial of Low Dose Decitabine (Dacogen) in Patients With Primary Myelofibrosis and Post ET/PV Myelofibrosis


Phase 2
18 Years
N/A
Not Enrolling
Both
Chronic Myeloproliferative Disorders, Secondary Myelofibrosis

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Trial Information

Phase II Trial of Low Dose Decitabine (Dacogen) in Patients With Primary Myelofibrosis and Post ET/PV Myelofibrosis


OBJECTIVES:

- Determine the efficacy and safety of low-dose decitabine in patients with symptomatic
primary myelofibrosis (PMF) or post essential thrombocythemic (ET) or polycythemic vera
(PV) myelofibrosis.

- Analyze the ability of this drug to decrease pathologic angiogenesis and other stromal
reactive features intrinsic to PMF or post ET/PV myelofibrosis.

OUTLINE: Patients receive low-dose decitabine IV over 1 hour on days 1-5. Treatment repeats
every 28 days for up to 6 courses in the absence of disease progression or unacceptable
toxicity. Patients achieving partial remission, complete remission, or clinical improvement
may receive up to 12 courses of decitabine in the absence of disease progression or
unacceptable toxicity.

After completion of study therapy, patients are followed periodically for up to 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histological confirmation of primary myelofibrosis or post essential thrombocythemic
or polycythemic vera myelofibrosis

- Reticulin fibrosis ≥ grade 1

- Evaluable and symptomatic disease worthy of treatment, characterized by ≥ 1 of the
following:

- Anemia, defined as hemoglobin < 11 g/dL or erythrocyte transfusion dependence

- Palpable and symptomatic splenomegaly (palpable and symptomatic hepatomegaly is
acceptable if previously splenectomized)

- Severe, disease-related constitutional symptoms, including ≥ 1 of the following:

- Severe night sweats

- Fevers

- Weight loss

- Bone pain

- Absence of t(9;22) by fluorescent in situ hybridization (FISH) or standard
cytogenetics OR prior demonstration of a lack of this translocation

PATIENT CHARACTERISTICS:

- Eastern Co-operative Oncology Group (ECOG) performance status 0-3

- Absolute neutrophil count (ANC) ≥ 1,000/mm³

- Platelet count ≥ 50,000/mm³

- Creatinine ≤ 2.0 mg/dL

- Direct or total bilirubin ≤ 2.0 mg/dL

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times upper
limit of normal (ULN) (≤ 5 times ULN if elevation is attributed to hepatic
extramedullary hematopoiesis)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Not incarcerated in a municipality, county, state, or federal prison

- No serious medical condition or psychiatric illness that would preclude signing the
informed consent

- No condition that, in the opinion of the treating physician, places the patient at
unacceptable risk for study participation or confounds the ability to interpret study
data

- Able to adhere to the study visit schedule and other study requirements

PRIOR CONCURRENT THERAPY:

- No other concurrent chemotherapy (e.g., hydroxyurea, thalidomide, interferon alpha,
anagrelide, or other myelosuppressive agent) or experimental therapy

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants Who Achieve a Confirmed Response (Complete Remission (CR), Partial Remission (PR), or Clinical Improvement (CI)), According to International Working Group (IWG) Consensus Criteria.

Outcome Description:

Confirmed response: objective status of CR, PR, or CI on 2 consecutive evaluations >=4 weeks apart. CR:Complete resolution of disease-related symptoms and signs; peripheral blood count remission; normal leukocyte differential; bone marrow histologic remission. PR: All criteria for CR except the bone marrow histologic remission. CI: one of the following in the absence of both disease progression and CR/PR: minimum (MI) 20-g/L increase (INC) in hemoglobin level; MI 50% reduction in palpable splenomegaly (>=10cm); MI 100% INC in platelet count(>=50000x10^9/L) or ANC (>=0.5x10^9/L)

Outcome Time Frame:

Every 4 weeks during treatment (up to 16 weeks)

Safety Issue:

No

Principal Investigator

Ruben A. Mesa, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000588839

NCT ID:

NCT00630994

Start Date:

March 2008

Completion Date:

April 2012

Related Keywords:

  • Chronic Myeloproliferative Disorders
  • Secondary Myelofibrosis
  • primary myelofibrosis
  • secondary myelofibrosis
  • essential thrombocythemia
  • polycythemia vera
  • Primary Myelofibrosis
  • Myeloproliferative Disorders

Name

Location

Mayo ClinicRochester, Minnesota  55905