Trial · NCT01542684
Study of Azacytidine Followed by GM-CSF in Patients With Myelodysplastic Syndrome (MDS)
NCT01542684, Phase 2, Terminated, M.D. Anderson Cancer Center; results first posted 2014-04-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Azacytidine Followed by GM-CSF in Patients With Myelodysplastic Syndrome (MDS). Trials, record NCT01542684. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01542684
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Azacytidine Followed by GM-CSF in Patients With Myelodysplastic Syndrome (MDS)
- NCT number
- NCT01542684
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Leukemia
- Interventions
- Azacytidine, GM-CSF
- First posted
- 2012-03-02
- Last updated
- 2014-04-30
- Results first posted
- 2014-04-30
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Baseline up to 2 treatment cycles (8 weeks) | ORR is percentage total participants with overall response (Complete Response (CR) or Partial Response (PR)) within two treatment cycles. Response based on modified International Working Group (IWG) criteria: Complete response - Bone marrow: 5% myeloblasts with normal maturation of all cell lines, Persistent dysplasia noted, Peripheral blood Hgb 11 g/dL, Platelets 100x109/L, Neutrophils 1.0x109/L, Blasts 0%. Partial response: All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by 50% over pretreatment but still \> 5% , Cellularity and morphology not relevant; Stable disease - Failure to achieve at least PR, but no evidence of progression for \> 8 weeks; No Response or Failure - Death during treatment or disease progression characterized by worsening of cytopenias, increase in percentage of bone marrow blasts, or progression to a more advanced MDS French-American-British (FAB) classification subtype than pretreatme |
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 | Overall Response Rate (ORR) | Baseline up to 2 treatment cycles (8 weeks) | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | Azacytidine + GM-CSF | Complete Response (CR) | 0 | percentage of participants | |
| Overall Response Rate (ORR) | Azacytidine + GM-CSF | Partial Response (PR) | 0 | percentage of participants | |
| Overall Response Rate (ORR) | Azacytidine + GM-CSF | No Response | 100 | 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 | Azacytidine + GM-CSF | 8 | |
| Overall Study | COMPLETED | Azacytidine + GM-CSF | 8 | |
| Overall Study | NOT COMPLETED | Azacytidine + GM-CSF | 0 |
Source ClinicalTrials.gov
Adverse events24
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 | Fever | General disorders | Azacytidine + GM-CSF | 4 | 8 | 6 |
| other | Nausea/Vomiting | Gastrointestinal disorders | Azacytidine + GM-CSF | 4 | 8 | 6 |
| other | Diarrhea | Gastrointestinal disorders | Azacytidine + GM-CSF | 2 | 8 | 3 |
| other | Chest Pain | General disorders | Azacytidine + GM-CSF | 1 | 8 | 1 |
| other | Consipation | Gastrointestinal disorders | Azacytidine + GM-CSF | 3 | 8 | 3 |
| other | Fatigue | General disorders | Azacytidine + GM-CSF | 4 | 8 | 4 |
| other | Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Azacytidine + GM-CSF | 2 | 8 | 2 |
| other | Dizziness | Nervous system disorders | Azacytidine + GM-CSF | 1 | 8 | 1 |
| other | Memory Change | Nervous system disorders | Azacytidine + GM-CSF | 1 | 8 | 3 |
| other | Blurred Vision | Nervous system disorders | Azacytidine + GM-CSF | 1 | 8 | 2 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Azacytidine + GM-CSF | ||
| Total, other adverse events | Azacytidine + GM-CSF | 8 | 8 |
| Total, serious adverse events | Azacytidine + GM-CSF | 3 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01542684
GET https://conductscience.org/api/trials/v1/NCT01542684/events?page=2