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NCT01083706 · REGISTRY CONDITION SEARCH

Azacitidine in Treating Patients With Relapsed Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant

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
2017-05-24

This phase II trial studies how well azacitidine works in treating patients with relapsed myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or acute myeloid leukemia (AML) who have undergone stem cell transplant. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

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

Overall Survival

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outcome · POSTED

Rate of Response by IWG Criteria

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outcome · POSTED

Incidence of Grades II-IV Graft-versus-host Disease (GVHD)

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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: * MDS, CMML or AML patients (as diagnosed by World Health Organization \[WHO\] criteria) with evidence of relapse or progression at \>= day 28 and \< day 100 post-transplant * Recurrent or increased cytogenetic abnormalities by standard karyotype or fluorescence in situ hybridization (FISH) (the cytogenetic abnormalities must have been previously documented at some time point between diagnosis and date of stem cell transplant) * Morphologic evidence of recurrence or increased abnormal myeloblasts in peripheral blood or marrow * Flow Cytometric evidence of disease as determined by recurrent or increased abnormal myeloblasts in peripheral blood or marrow * Extramedullary relapse (local radiotherapy will be allowed) * MDS, CMML, or AML patients with persistent stable disease or persistent disease with regression at \>= day 28 and \< day 100 post-transplant; the inclusion of patients with persistent stable or persistent regressing disease in this protocol is not meant to advocate treatment; however, if the attending physician is inclined to offer treatment then these patients would be eligible for this study * Persistence of cytogenetic abnormalities by standard karyotype or FISH * Persistent morphologic evidence of abnormal myeloblasts (in patients with CMML the monoblastoid population is included) in peripheral blood or marrow * Persistent flow cytometric evidence of abnormal myeloblasts (in patients with CMML the monoblastoid population is included) in peripheral blood or marrow * Extramedullary persistence or regression Exclusion Criteria: * Refractory disease at time of stem cell transplant; patients who received chemotherapy prior to transplant with no evidence of response by International Working Group (IWG) criteria * \>= 10% bone marrow myeloblasts as measured by morphology * Evidence of central nervous system (CNS) disease at time of relapse by morphology or flow (a diagnostic lumbar puncture \[LP\] is not required at time of relapse) * Serum creatinine \> 2 x ULN (upper limit of normal) * Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) \> 2x ULN * Performance status \> 2 (Eastern Cooperative Oncology Group \[ECOG\] Scale) * Patients with severe disease other than MDS, CMML or AML which would be expected to prevent compliance with treatment * Patients with severe infections (pneumonia, sepsis, etc) within the 2 weeks prior to the anticipated start of protocol treatment
healthy Volunteers
false
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: azacitidine
    2. Other: laboratory biomarker analysis
    label
    Treatment (chemotherapy)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (chemotherapy)
    description
    Given SC or IV
    name
    azacitidine
    other Names
    1. 5-AC
    2. 5-azacytidine
    3. azacytidine
    4. Vidaza
    type
    DRUG
  2. arm Group Labels
    1. Treatment (chemotherapy)
    description
    Correlative studies
    name
    laboratory biomarker analysis
    type
    OTHER
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
43
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Count of surviving participants at 6 months.
    measure
    Overall Survival
    time Frame
    6 months
secondary Outcomes
  1. description
    Count of participants achieving a complete or partial remission at 6 months.
    measure
    Rate of Response by IWG Criteria
    time Frame
    6 months
  2. measure
    Incidence of Grades II-IV Graft-versus-host Disease (GVHD)
    time Frame
    6 months
Full study description
brief Summary
This phase II trial studies how well azacitidine works in treating patients with relapsed myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or acute myeloid leukemia (AML) who have undergone stem cell transplant. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
detailed Description
PRIMARY OBJECTIVES: I. To improve overall survival in patients with post-transplant relapse of myeloid malignancies. OUTLINE: Patients receive azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Source references
Source notices and limitations
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    Preserved source evidence · Not medical advice