Clinical trial · Interventional
5-Azacytidine (Azacytidine; Vidaza) in Chronic Lymphocytic Leukemia
Phase II Study of 5-Azacytidine (Azacytidine; Vidaza) in Chronic Lymphocytic Leukemia
NCT00413478CI-TRIAL-00018399terminatedPhase 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): Slow accrual.
Summary
Brief summary (as posted)
The objective of this study is to determine the safety and efficacy of Azacytidine in fludarabine-resistant chronic lymphocytic leukemia (CLL), Richter's transformation, and T-cell prolymphocytic leukemia (T-PLL).
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 Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Azacytidine | Drug | Azacitidine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 5-Azacytidine
- description
- 5-Azacytidine 75mg/m\^2 subcutaneously daily for seven days. Treatment cycles will be repeated every 3-8 weeks.
- interventionNames
- Drug: 5-Azacytidine
Primary outcomes (1)
- measure
- Tumor Response Rate (Complete, Partial) of Azacytidine
- timeFrame
- 3 to 8 weeks treatment cycles, continuation up to 1 year
- description
- Overall response rate includes percentage of participants with complete response (CR) plus partial response (PR) responses using the National Cancer Institute (NCI) International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria for response: Complete response defined as no palpable lymph nodes, liver or spleen and absence of symptoms. Neutrophil count \> 15,00/Mic L, and platelet count more than 100,000/MicL. Hemoglobin should be \> 11g/dl without transfusions. Lymphocyte count \<4000/micL. On bone marrow aspirate lymphocyte % should be \<30%, and biopsy showing no lymphocyte infiltrate. A partial response was defined as more than or equal to 50% decrease in lymph nodes and liver and spleen size. Neutrophils \> 1500/ micL or \>50 % improvement from baseline, platelet count \>100,000/micL or \>50 % improvement from baseline. Hemoglobin \>11g/dl or \>50% improvement from baseline. A reduction of \>50% in Leukocyte count or \<30 % lymphocytes with residual disease on biopsy for nodular PR.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with chronic lymphocytic leukemia (CLL), prolymphocytic leukemia, Richter's transformation or T-PLL who have previously been treated with fludarabine or another regime are eligible. 2. Patients with histologically or cytologically confirmed Richter's transformation. 3. Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) less than x 2 normal levels. 4. Women of childbearing potential who have a negative pregnancy test prior to azacytidine treatment. 5. Women of childbearing potential who agreed not to become pregnant and men agreed not to father a child while on azacytidine treatment. 6. Performance 0-2 (ECOG). Adequate liver function (bilirubin of less than2mg/dl) and renal function (creatinine less than 2mg/dl). Adequate cardiac functions (NYHA cardiac III-IV excluded). 7. Signed informed consent. Exclusion Criteria: 1. Breast feeding or pregnant females. Patients of (male and female) childbearing potential should practice effective methods of contraception; otherwise, they will be excluded. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 2. Known or suspected hypersensitivity to azacytidine or Mannitol. 3. Active and uncontrolled infections. 4. Patients with advanced malignant hepatic tumors. 5. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
References
Publications (1)
- RESULTMalik A, Shoukier M, Garcia-Manero G, Wierda W, Cortes J, Bickel S, Keating MJ, Estrov Z. Azacitidine in fludarabine-refractory chronic lymphocytic leukemia: a phase II study. Clin Lymphoma Myeloma Leuk. 2013 Jun;13(3):292-5. doi: 10.1016/j.clml.2012.11.009. Epub 2012 Dec 21. PMID 23265768