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Treatment of Post-Transplant Relapse and Persistent Disease in Patients With MDS, CMML and AML With Azacitidine


Phase 2
N/A
N/A
Open (Enrolling)
Both
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

Thank you

Trial Information

Treatment of Post-Transplant Relapse and Persistent Disease in Patients With MDS, CMML and AML With Azacitidine


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Bart Scott

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Federal Government

Study ID:

2240.00

NCT ID:

NCT01083706

Start Date:

April 2010

Completion Date:

Related Keywords:

  • 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
  • Congenital Abnormalities
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelomonocytic, Chronic
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Acute

Name

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109