Clinical trial · Interventional
Azacitidine in Treating Patients With Myelofibrosis
Phase II Study of Azacitidine in Myelofibrosis
NCT00381693CI-TRIAL-00004716terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to lack of accrual and trial has demonstrated too little clinical benefit
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of abnormal cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well azacitidine works in treating patients with myelofibrosis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Secondary Myelofibrosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| azacitidine | Drug | Azacitidine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Patients With Confirmed Response (Complete Remission or Partial Remission on 2 Consecutive Evaluation at Least 4 Weeks Apart) During the First 4 Months of Treatment
- timeFrame
- 4 months
- description
- Response Definitions: * Completion Remission (CR):complete resolution of disease-related symptoms, ultrasound-documented resolution of hepastosplenomegaly, normalization of the peripheral blood count, white cell differential, and smear, normalization of bone marrow histology including disappearance of fibrosis and osteosclerosis. Residual cytogenetic abnormalities are allowed. * Partial Remission (PR): a major response in any baseline applicable criteria (except constitutional symptoms) without progression in any other category.
Secondary outcomes (3)
- measure
- Overall Survival (OS)
- timeFrame
- From date of registration until death or 3 years after registration if patient is still alive
- description
- OS was defined as the time from registration to death due to any cause or time from registration to 3 years after registration if patient is still alive.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed myelofibrosis with myeloid metaplasia (MMM), including any of the following subtypes: * Agnogenic myeloid metaplasia * Post-polycythemic myeloid metaplasia * Post-thrombocythemic myeloid metaplasia * Evaluable and symptomatic disease, defined as 1 of the following: * Anemia (hemoglobin \< 10 g/dL or erythrocyte transfusion-dependent, requiring 1 transfusion ≤ 8 weeks) * Treatment required\* for symptomatic palpable splenomegaly (palpable hepatomegaly is acceptable if previously splenectomized) NOTE: \*Subjective but painful enough to mandate intervention * Absence of t(9;22) by fluorescent in situ hybridization (FISH) or standard cytogenetics (by peripheral blood or marrow) \- Previous demonstration of a lack of this translocation (at any point) is sufficient * No advanced malignant hepatic tumors PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Absolute neutrophil count ≥ 1,000/mm³ * Platelet count ≥ 50,000/mm³ * Creatinine ≤ 2.0 mg/dL * Total bilirubin ≤ 2.0 mg/dL OR direct bilirubin ≤ 2.0 mg/dL if total bilirubin elevated (unless attributed to underlying disease) * AST and ALT ≤ 2 times upper limit of normal (unless clinically attributed to hepatic extramedullary hematopoiesis) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No baseline peripheral or autonomic neuropathy ≥ grade 2 * No condition, including the presence of laboratory abnormalities, that would preclude study compliance * No hypersensitivity to mannitol or azacitidine * Not incarcerated in a municipality (i.e., county, state, or federal prison) PRIOR CONCURRENT THERAPY: * At least 14 days since prior chemotherapy, including interferon alfa, anagrelide, or other myelosuppressive agents * At least 14 days since prior systemic corticosteroids * At least 14 days since prior investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.