A Study of 5-Azacitidine (Vidaza®) in Patients With Chronic Myelomonocytic Leukemia

NCT01350947 | Completed Phase 2 Results DMC

• 1 other identifier: HCI47081
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

Brief Summary

The primary objective of this study is: Response to treatment will be evaluated according to the revised International Working Group (IWG) categories natural history, hematologic improvement and cytogenetic response1;2. The primary objective is: To determine the rate of complete hematologic response and hematologic improvement (according to IWG 2006 criteria) in CMML patients treated with 5-azacitidine.

Conditions

Chronic Myelomonocytic Leukemia

Keywords

Chronic Myelomonocytic Leukemia; CMML

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Complete Hematologic Response (According to IWG 2006 Criteria) in CMML Patients Treated With 5-azacitidine.

  Complete Hematologic Response is defined as: bone marrow evaluation shows \<= 5% myeloblasts with normal maturation of all cells lines; peripheral blood evaluation shows hemoglobin \>= 11 g/dL, neutrophils \>= 1000/mL, platelets \>= 100,000/mL, 0% blasts

  24 months

Study Arms (1)

All patients

EXPERIMENTAL

All participants enrolled.

Drug: 5-Azacitidine

Interventions

5-Azacitidine DRUG

Administered on Days 1-7 of each Cycle. Subcutaneous administration: To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration. The 5-azacitidine suspension is administered subcutaneously. Intravenous Administration: 5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes.

Also known as: Vidaza®

All patients

Eligibility Criteria

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

You may qualify if:

• Diagnosis of CMML as defined by the WHO criteria
• Persistent peripheral blood monocytosis of more than 1 x 109/L for at least 3 months and
• No Philadelphia chromosome or BCR-ABL fusion gene and
• Less than 20% blasts in the blood or bone marrow and
• Dysplasia in one or more of the myeloid lineages\* \* In the absence of dysplasia in one or more of the myeloid lineages, the diagnosis of CMML can still be made if a) - c) are met AND an acquired clonal chromosomal abnormality is present in the bone marrow cells, the monocytosis has been present for more than 3months AND all other causes of monocytosis have been ruled out.
• Age of 18 years or older. Both men and women and members of all races and ethnic groups will be included.
• ECOG performance status \<3
• Adequate organ function defined as:
• Total bilirubin \<2.5 x upper limit of normal (ULN)
• Direct bilirubin \<2 x ULN
• Creatinine \<2 mg/dL
• ALT and AST \<2.5 x ULN
• Ability to understand and the willingness to sign a written informed consent document
• Willingness to use adequate contraception for the duration of the study

You may not qualify if:

• Progression to acute myeloid leukemia (defined by at least 20% blasts in the blood or bone marrow). In the unlikely event that progression to acute leukemia is demonstrated in the "screening" bone marrow biopsy, it is at the discretion of the investigator to enroll the patient after adequate discussion of the findings and alternative therapies. Enrollment of such a patient must be reported to the HCI PI.
• Presence of activating mutations of the platelet derived growth factor receptors alpha or beta, which would suggest likely benefit from imatinib treatment (these mutations will usually be obvious from karyotyping and fluorescence in situ hybridization studies)
• Known or suspected hypersensitivity to 5-azacitidine or mannitol
• Clinically significant heart disease (New York Heart Association Class III or IV) or other serious intercurrent illnesses or psychiatric illness/social situations that would limit compliance with study requirements
• Major surgery within 28 days before registration (exception: central venous line placement), or lack of full recovery from prior major surgery
• Prior therapy with a hypomethylating agent
• Cytotoxic chemotherapy less than 2 weeks prior to starting study medication (exception: hydroxyurea and/or anagrelide)
• Erythropoietin or darbepoietin, G-CSF, GM-CSF, thalidomide or lenalidomide less than 2 weeks from day 1 of cycle 1
• Concomitant cytotoxic chemotherapy (exception: hydroxyurea for up to 1 week per cycle)
• Concomitant therapy with other investigational agents
• Other active malignancies except basal cell carcinoma of the skin and carcinoma in situ of the cervix.
• Pregnancy or breastfeeding (possible risk to the fetus or infant)

Sponsors & Collaborators

• University of Utah: lead
• Celgene: collaborator

Study Sites (3)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Leukemia, Myelomonocytic, Chronic

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

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: Mark Wade
• Organization: Huntsman Cancer Institute

mark.wade@hci.utah.edu

801-213-5746

Study Officials

• Michael Deininger, MD

  University of Utah

  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: SPONSOR

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: May 10, 2011
• Study Start: April 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 13, 2016
• Results First Posted: October 29, 2015

Record last verified: 2016-05

Locations

US (3)