Phase 2
N=34
Ph II Study of Azacitidine in Myelofibrosis
Myelofibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00569660 ↗Enrolled (actual)
34
Serious AEs
50.0%
Results posted
Mar 2011
Primary outcome: Primary: Number of Participants With Objective Clinical Response — 0; 1; 7; 26 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Azacitidine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Objective Clinical Response |
0; 1; 7; 26 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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) 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 /= 18.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00569660). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.