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NCT01350947 · REGISTRY CONDITION SEARCH

A Study of 5-Azacitidine (Vidaza®) in Patients With Chronic Myelomonocytic Leukemia

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2016-06-13

The primary objective of this study is: Response to treatment will be evaluated according to the revised International Working Group (IWG) categories natural history, hematologic improvement and cytogenetic response1;2. The primary objective is: To determine the rate of complete hematologic response and hematologic improvement (according to IWG 2006 criteria) in CMML patients treated with 5-azacitidine.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Patients With Complete Hematologic Response (According to IWG 2006 Criteria) in CMML Patients Treated With 5-azacitidine.

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: 1. Diagnosis of CMML as defined by the WHO criteria 1. Persistent peripheral blood monocytosis of more than 1 x 109/L for at least 3 months and 2. No Philadelphia chromosome or BCR-ABL fusion gene and 3. Less than 20% blasts in the blood or bone marrow and 4. Dysplasia in one or more of the myeloid lineages\* \* In the absence of dysplasia in one or more of the myeloid lineages, the diagnosis of CMML can still be made if a) - c) are met AND an acquired clonal chromosomal abnormality is present in the bone marrow cells, the monocytosis has been present for more than 3months AND all other causes of monocytosis have been ruled out. 2. Age of 18 years or older. Both men and women and members of all races and ethnic groups will be included. 3. ECOG performance status \<3 4. Adequate organ function defined as: 1. Total bilirubin \<2.5 x upper limit of normal (ULN) 2. Direct bilirubin \<2 x ULN 3. Creatinine \<2 mg/dL 4. ALT and AST \<2.5 x ULN 5. Ability to understand and the willingness to sign a written informed consent document 6. Willingness to use adequate contraception for the duration of the study Exclusion Criteria: 1. Progression to acute myeloid leukemia (defined by at least 20% blasts in the blood or bone marrow). In the unlikely event that progression to acute leukemia is demonstrated in the "screening" bone marrow biopsy, it is at the discretion of the investigator to enroll the patient after adequate discussion of the findings and alternative therapies. Enrollment of such a patient must be reported to the HCI PI. 2. Presence of activating mutations of the platelet derived growth factor receptors alpha or beta, which would suggest likely benefit from imatinib treatment (these mutations will usually be obvious from karyotyping and fluorescence in situ hybridization studies) 3. Known or suspected hypersensitivity to 5-azacitidine or mannitol 4. Clinically significant heart disease (New York Heart Association Class III or IV) or other serious intercurrent illnesses or psychiatric illness/social situations that would limit compliance with study requirements 5. Major surgery within 28 days before registration (exception: central venous line placement), or lack of full recovery from prior major surgery 6. Prior therapy with a hypomethylating agent 7. Cytotoxic chemotherapy less than 2 weeks prior to starting study medication (exception: hydroxyurea and/or anagrelide) 8. Erythropoietin or darbepoietin, G-CSF, GM-CSF, thalidomide or lenalidomide less than 2 weeks from day 1 of cycle 1 9. Concomitant cytotoxic chemotherapy (exception: hydroxyurea for up to 1 week per cycle) 10. Concomitant therapy with other investigational agents 11. Other active malignancies except basal cell carcinoma of the skin and carcinoma in situ of the cervix. 12. Pregnancy or breastfeeding (possible risk to the fetus or infant)
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    All participants enrolled.
    intervention Names
    1. Drug: 5-Azacitidine
    label
    All patients
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. All patients
    description
    Administered on Days 1-7 of each Cycle. Subcutaneous administration: To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration. The 5-azacitidine suspension is administered subcutaneously. Intravenous Administration: 5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes.
    name
    5-Azacitidine
    other Names
    1. Vidaza®
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
11
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Complete Hematologic Response is defined as: bone marrow evaluation shows \<= 5% myeloblasts with normal maturation of all cells lines; peripheral blood evaluation shows hemoglobin \>= 11 g/dL, neutrophils \>= 1000/mL, platelets \>= 100,000/mL, 0% blasts
    measure
    Percentage of Patients With Complete Hematologic Response (According to IWG 2006 Criteria) in CMML Patients Treated With 5-azacitidine.
    time Frame
    24 months
Full study description
brief Summary
The primary objective of this study is: Response to treatment will be evaluated according to the revised International Working Group (IWG) categories natural history, hematologic improvement and cytogenetic response1;2. The primary objective is: To determine the rate of complete hematologic response and hematologic improvement (according to IWG 2006 criteria) in CMML patients treated with 5-azacitidine.
detailed Description
In this study, eligible patients with a confirmed diagnosis of CMML will be treated with 5-azacitidine to determine the rates of complete hematologic response, hematologic improvement, complete and partial cytogenetic response, and overall and progression free survival. To develop biomarkers associated with response and gain insights into the mechanisms that determine response, gene expression profiling, genome-wide SNP array analysis, microRNA analysis, and DNA methylation analysis will be performed prior to therapy and at defined time points during the study. Phosphoproteomics profiling may be included in the analysis.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
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      requested nct id
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      primary nct id
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      source kind
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      source file sha256
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      payload sha256
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      payload
      clinical indication matching status
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      end exclusive
      true
      id
      nct-edge-7b9be3943051a098127d
      link basis
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      nct id
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      occurrences
      1. context exact
        NCT01350947
        end
        11
        exact text
        NCT01350947
        start
        0
      offset unit
      unicode_code_points
      query cond
      Juvenile Myelomonocytic Leukemia
      query disease state id
      ds-juvenile-myelomonocytic-leukemia
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-juvenile-myelomonocytic-leukemia-000.json
      source file sha256
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      source json pointer
      /studies/65/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      cb489f3f6a13c4e4e0a295fe7e86b1b6a004c9dc870fcd972a0b9da3f2a56dd6

    Preserved source evidence · Not medical advice