NCT00569660

Brief Summary

The goal of this clinical research study is to learn if azacitidine can help to control MF. The safety of azacitidine in patients with Myelofibrosis (MF) will also be studied.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
3 years until next milestone

Results Posted

Study results publicly available

March 30, 2011

Completed
Last Updated

August 7, 2012

Status Verified

August 1, 2012

Enrollment Period

2.8 years

First QC Date

December 6, 2007

Results QC Date

September 21, 2009

Last Update Submit

August 1, 2012

Conditions

Myelofibrosis

Keywords

MyelofibrosisMFLeukemiaAzacitidineVidaza

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Objective Clinical Response

    Objective Clinical Response includes Participants with Complete Response, Partial Response or Hematologic Improvement and No Response. Bone marrow aspiration and biopsy with cytogenetics every 2 to 4 courses.

    Every 2 courses of 4 week therapy = each 8 weeks

Study Arms (1)

Azacitidine

EXPERIMENTAL

75 mg/m\^2 Subcutaneous Daily for 7 days every 4 weeks

Drug: Azacitidine

Interventions

AzacitidineDRUG

75 mg/m\^2 subcutaneous daily for 7 days (every 4 week cycle)

Also known as: Vidaza
Azacitidine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of MF requiring therapy, including those previously treated and relapsed or refractory, or if newly diagnosed, with intermediate or high risk according to Lille scoring system (adverse prognostic factors are: Hemoglobin (Hb) \< 10 g/dl, White Blood Cell (WBC) \< 4 or \> 30 x 10\*9/L; risk group: 0 = low, 1 = intermediate, 2 = high).
  • Performance 0-2 Eastern Cooperative Oncology Group (ECOG).
  • Signed informed consent.
  • Patients must have been off chemotherapy for 2 weeks prior to entering this study and have recovered from the toxic effects (grade 0-1) of that therapy. Patients are allowed to be on anagrelide and hydroxyurea to control high platelet and WBC counts for their safety.
  • Serum bilirubin levels \</= 1.5 times the upper limit of the normal range for the laboratory Upper Limit of of Normal(ULN). Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis.
  • Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) levels \</= 2 x ULN.
  • Serum creatinine levels \</= 1.5 x ULN; unless related to the MF, as judged by treating physicians.
  • Women of childbearing potential must have a negative serum pregnancy test prior to azacitidine treatment and should be advised to avoid becoming pregnant. Men must be advised to not father a child while receiving treatment with azacitidine. Both women of childbearing potential and men must practice effective methods of contraception (those generally accepted as standard of care measures).
  • Age \>/= 18.

You may not qualify if:

  • Nursing and pregnant females. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Uncontrolled intercurrent illness including, but not limited to, uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Known or suspected hypersensitivity to azacitidine or mannitol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Primary MyelofibrosisLeukemia

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Myeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Results Point of Contact

Title
Srdan Verstovsek M.D./Associate Professor
Organization
The University of Texas M. D. Anderson Cancer Center
eharriso@mdanderson.org
713-792-7305

Study Officials

  • Srdan Verstovsek, M.D.

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2007

First Posted

December 7, 2007

Study Start

June 1, 2005

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

August 7, 2012

Results First Posted

March 30, 2011

Record last verified: 2012-08

Locations

US(1)