Clinical trial · Interventional
Azacitidine in Treating Patients With Chronic Myelomonocytic Leukemia
A Phase 2 Study of Azacitidine in Chronic Myelomonocytic Leukemia (CMML)
NCT01235117CI-TRIAL-00011924completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: 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. PURPOSE: This phase II trial is studying the side effects of azacitidine and to see how well it works in treating patients with chronic myelomonocytic leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| azacitidine | Drug | Azacitidine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Safety and tolerability
- measure
- Overall response rate
Secondary outcomes (7)
- measure
- Incidence of clinical remission/complete remission or partial response according to International Working Group (IWG) criteria
- measure
- Hematological improvement according to IWG criteria
- measure
- Overall survival
- measure
- Progression-free survival
- measure
- Time to acute myeloid leukemia (AML) transformation of CMML
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following:
* All chronic myelomonocytic leukemia (CMML)-2 patients
* CMML-1 patients meeting any of the following criteria:
* Symptomatic bone marrow failure/myeloproliferation defined as any of the following:
* Red cell transfusion dependence and pre-transfusion hemoglobin \< 9.0 g/dL
* Symptomatic anemia (hemoglobin \< 11.5 g/dL)
* Thrombocytopenia (platelet count \< 50 x 10\^9/L)
* Symptomatic bleeding due to platelet functional defect or disseminated intravascular coagulation (DIC)/fibrinolysis
* White cell count (WCC) \> 50 x 10\^9/L
* Düsseldorf Score of intermediate or high risk for proliferative CMML-1 (i.e., WCC \> 12 x 10\^9/L)
* International Prognostic Scoring System (IPSS) score of intermediate-2 or high risk for non-proliferative CMML-1 (i.e., WCC \< 12 x 10\^9/L)
* Systemic symptoms including weight loss with no alternative explanation (10% of baseline weight within the past 6 months)
* Symptomatic splenomegaly
* Symptomatic extramedullary involvement (e.g. skin infiltration or serous effusions)
* No CMML with eosinophilia and 5q33 abnormality
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* Creatinine ≤ 2 times upper limit of normal
* Not pregnant or nursing
* Negative urine pregnancy test
* Fertile patients must use at least 2 forms of effective contraception during study and for 3 months after completion of study therapy
* No other active malignant disease including basal cell or squamous cell carcinoma of the skin
* No known HIV or infectious hepatitis B or hepatitis C
* No active infection
* No known hypersensitivity to azacitidine or mannitol
PRIOR CONCURRENT THERAPY:
* At least 28 days since other prior experimental drug or therapy
* No prior chemotherapy for this disease except hydroxycarbamide
* No other concurrent anticancer or investigational agentsReferences
Publications (0)
Data not yet available
No reference posted for this study.