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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01083706
• Date of registration: 08/03/2010
• Prospective Registration: Yes
• Primary sponsor: Fred Hutchinson Cancer Research Center
• Public title: Azacitidine in Treating Patients With Relapsed Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant
• Scientific title: Treatment of Post-Transplant Relapse and Persistent Disease in Patients With MDS, CMML and AML With Azacitidine
• Date of first enrolment: April 2010
• Target sample size: 43
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01083706
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Bart Scott
• Affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)

Secondary Myelodysplastic Syndromes

Adult Acute Myeloid Leukemia With Del(5q)

Previously Treated Myelodysplastic Syndromes

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)

Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)

Childhood Myelodysplastic Syndromes

Recurrent Adult Acute Myeloid Leukemia

Recurrent Childhood Acute Myeloid Leukemia

Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)

Chronic Myelomonocytic Leukemia

Intervention(s)

Drug: azacitidine

Other: laboratory biomarker analysis

Primary Outcome(s)

Overall Survival [Time Frame: 6 months]

Secondary Outcome(s)

Rate of Response by IWG Criteria [Time Frame: 6 months]

Incidence of Grades II-IV Graft-versus-host Disease (GVHD) [Time Frame: 6 months]

Secondary ID(s)

NCI-2010-00281

P30CA015704

P01CA078902

2240.00

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)

Celgene Corporation

Results

• Results available: Yes
• Date Posted: 24/05/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01083706