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

NCT01083706 | Completed Phase 2 Results DMC

• 4 other identifiers: 2240.00NCI-2010-00281P30CA015704P01CA078902
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Count of surviving participants at 6 months.

  6 months

Secondary Outcomes (2)

• Rate of Response by IWG Criteria

  6 months

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

  6 months

Study Arms (1)

Treatment (chemotherapy)

EXPERIMENTAL

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.

Drug: azacitidine; Other: laboratory biomarker analysis

Interventions

azacitidine DRUG

Given SC or IV

Also known as: 5-AC, 5-azacytidine, azacytidine, Vidaza

Treatment (chemotherapy)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (chemotherapy)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• Celgene Corporation: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Congenital Abnormalities; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myelodysplastic-Myeloproliferative Diseases; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Bart Scott
• Organization: Fred Hutchinson Cancer Research Center

bscott@fredhutch.org

206-667-1990

Study Officials

• Bart Scott

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 10, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2013
• Last Updated: May 24, 2017
• Results First Posted: May 24, 2017

Record last verified: 2017-04

Locations

US (1)