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

This study has been completed.
Sponsor:
Collaborators:
Celgene Corporation
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01083706
First received: March 8, 2010
Last updated: December 10, 2013
Last verified: December 2013

March 8, 2010
December 10, 2013
April 2010
December 2013   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01083706 on ClinicalTrials.gov Archive Site
  • Rate of response by IWG criteria [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Incidence of grades II-IV graft-versus-host disease (GVHD) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Rate of response by IWG criteria [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Red blood cell and platelet transfusion requirements [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Incidence of grades II-IV GVHD [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Azacitidine in Treating Patients With Relapsed Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant
Treatment of Post-Transplant Relapse and Persistent Disease in Patients With MDS, CMML and AML With Azacitidine

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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)
  • Childhood Myelodysplastic Syndromes
  • Chronic Myelomonocytic Leukemia
  • Previously Treated Myelodysplastic Syndromes
  • Recurrent Adult Acute Myeloid Leukemia
  • Recurrent Childhood Acute Myeloid Leukemia
  • Secondary Myelodysplastic Syndromes
  • Drug: azacitidine
    Given SC or IV
    Other Names:
    • 5-AC
    • 5-azacytidine
    • azacytidine
    • Vidaza
  • Other: laboratory biomarker analysis
    Correlative studies
Experimental: Treatment (chemotherapy)
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.
Interventions:
  • Drug: azacitidine
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
Not Provided
December 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01083706
2240.00, NCI-2010-00281, 2240.00, P30CA015704, P01CA078902
Yes
Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
  • Celgene Corporation
  • National Cancer Institute (NCI)
Principal Investigator: Bart Scott Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Fred Hutchinson Cancer Research Center
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP