Study Stopped
Slow accrual.
5-Azacytidine (Azacytidine; Vidaza) in Chronic Lymphocytic Leukemia
Phase II Study of 5-Azacytidine (Azacytidine; Vidaza) in Chronic Lymphocytic Leukemia
2 other identifiers
interventional
9
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2006
Longer than P75 for phase_2
1 active site
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
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 15, 2006
CompletedFirst Posted
Study publicly available on registry
December 19, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedResults Posted
Study results publicly available
June 30, 2015
CompletedJune 30, 2015
June 1, 2015
8.2 years
December 15, 2006
June 3, 2015
June 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tumor Response Rate (Complete, Partial) of Azacytidine
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.
3 to 8 weeks treatment cycles, continuation up to 1 year
Study Arms (1)
5-Azacytidine
EXPERIMENTAL5-Azacytidine 75mg/m\^2 subcutaneously daily for seven days. Treatment cycles will be repeated every 3-8 weeks.
Interventions
Starting dose level: 75mg/m\^2 subcutaneously daily for seven days. Treatment cycles will be repeated every 3-8 weeks.
Eligibility Criteria
You may qualify if:
- 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.
- Patients with histologically or cytologically confirmed Richter's transformation.
- Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) less than x 2 normal levels.
- Women of childbearing potential who have a negative pregnancy test prior to azacytidine treatment.
- Women of childbearing potential who agreed not to become pregnant and men agreed not to father a child while on azacytidine treatment.
- 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).
- Signed informed consent.
You may not qualify if:
- 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.
- Known or suspected hypersensitivity to azacytidine or Mannitol.
- Active and uncontrolled infections.
- Patients with advanced malignant hepatic tumors.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Celgene Corporationcollaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Malik 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: 23265768RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Early termination led to small numbers of subjects analyzed.
Results Point of Contact
- Title
- Zeev Estrov, MD/Professor, Leukemia
- Organization
- University of Texas (UT) MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Zeev Estrov, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2006
First Posted
December 19, 2006
Study Start
September 1, 2006
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
June 30, 2015
Results First Posted
June 30, 2015
Record last verified: 2015-06