Trial · NCT00413478
5-Azacytidine (Azacytidine; Vidaza) in Chronic Lymphocytic Leukemia
NCT00413478, Phase 2, Terminated, M.D. Anderson Cancer Center; results first posted 2015-06-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 5-Azacytidine (Azacytidine; Vidaza) in Chronic Lymphocytic Leukemia. Trials, record NCT00413478. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00413478
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 5-Azacytidine (Azacytidine; Vidaza) in Chronic Lymphocytic Leukemia
- NCT number
- NCT00413478
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Chronic Lymphocytic Leukemia, Leukemia
- Interventions
- 5-Azacytidine
- First posted
- 2006-12-19
- Last updated
- 2015-06-30
- Results first posted
- 2015-06-30
- Limitations and caveats
- Early termination led to small numbers of subjects analyzed.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tumor Response Rate (Complete, Partial) of Azacytidine | 3 to 8 weeks treatment cycles, continuation up to 1 year | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tumor Response Rate (Complete, Partial) of Azacytidine | 3 to 8 weeks treatment cycles, continuation up to 1 year | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tumor Response Rate (Complete, Partial) of Azacytidine | 5-Azacytidine | 0 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 5-Azacytidine | 9 | |
| Overall Study | COMPLETED | 5-Azacytidine | 9 | |
| Overall Study | NOT COMPLETED | 5-Azacytidine | 0 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Thrombocytopenia | Blood and lymphatic system disorders | 5-Azacytidine | 1 | 9 | |
| other | Anemia | Blood and lymphatic system disorders | 5-Azacytidine | 1 | 9 | |
| other | Neutropenia | Blood and lymphatic system disorders | 5-Azacytidine | 3 | 9 | |
| other | Diarrhea | Gastrointestinal disorders | 5-Azacytidine | 2 | 9 | |
| other | Skin Rash | Skin and subcutaneous tissue disorders | 5-Azacytidine | 3 | 9 | |
| other | Infections | Infections and infestations | 5-Azacytidine | 6 | 9 | |
| other | Fever | General disorders | 5-Azacytidine | 2 | 9 | |
| other | Pneumonia | Infections and infestations | 5-Azacytidine | 3 | 9 | |
| other | Vomiting | Gastrointestinal disorders | 5-Azacytidine | 2 | 9 | |
| other | Arrythmia | Cardiac disorders | 5-Azacytidine | 1 | 9 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 5-Azacytidine | ||
| Total, other adverse events | 5-Azacytidine | 9 | 9 |
| Total, serious adverse events | 5-Azacytidine | 0 | 9 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23265768 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00413478
GET https://conductscience.org/api/trials/v1/NCT00413478/events?page=2