Trial · NCT00806598
Thymoglobulin and Cyclosporine in Patients With Aplastic Anemia or Myelodysplastic Syndrome
NCT00806598, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2013-03-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Thymoglobulin and Cyclosporine in Patients With Aplastic Anemia or Myelodysplastic Syndrome. Trials, record NCT00806598. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00806598
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Thymoglobulin and Cyclosporine in Patients With Aplastic Anemia or Myelodysplastic Syndrome
- NCT number
- NCT00806598
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 53 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Myelodysplastic Syndrome, Aplastic Anemia
- Interventions
- Thymoglobulin, Cyclosporine, Methylprednisolone, G-CSF
- First posted
- 2008-12-11
- Last updated
- 2013-03-12
- Results first posted
- 2013-03-06
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 | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Assessed first at 3 months on study, continuing monthly up to 3 years. | Complete response (CR) was defined as normalization of peripheral blood and bone marrow with \<5% blasts, a peripheral absolute neutrophil count (ANC) \>/= 1 \* 10\^9/l, hemoglobin \>/= 100g/l, and a platelet count \>/= \* 10\^9/l, Partial Response (PR) was defined as transfusion independence with a peripheral blood ANC \>=/ 0.05 \* 10\^9/l, a platelet count \>/= 20 \* 10\^9/l, and a hemoglobin \>/= 40 g/l. Hematologic improvement was defined as a clinically relevant increase in hemoglobin, platelets or absolute neutrophil count. |
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 | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Assessed first at 3 months on study, continuing monthly up to 3 years. | Of the 48 participants who received treatment 46 were evaluable for response. | 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 | Thymoglobulin + Cyclosporin | Complete Response | 8 | participants | |
| Overall Response | Thymoglobulin + Cyclosporin | Partial Response | 8 | participants | |
| Overall Response | Thymoglobulin + Cyclosporin | Hematological Improvement | 4 | 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 | Thymoglobulin + Cyclosporin | 48 | |
| Overall Study | COMPLETED | Thymoglobulin + Cyclosporin | 48 | |
| Overall Study | NOT COMPLETED | Thymoglobulin + Cyclosporin | 0 |
Source ClinicalTrials.gov
Adverse events30
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 | Neutropenia | Blood and lymphatic system disorders | Thymoglobulin + Cyclosporin | 24 | 48 | 24 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Thymoglobulin + Cyclosporin | 22 | 48 | 22 |
| other | Elevated Creatinine | Renal and urinary disorders | Thymoglobulin + Cyclosporin | 19 | 48 | 19 |
| other | Elevated Transaminases | Hepatobiliary disorders | Thymoglobulin + Cyclosporin | 16 | 48 | 16 |
| other | Elevated Bilirubin | Hepatobiliary disorders | Thymoglobulin + Cyclosporin | 15 | 48 | 15 |
| other | Anemia | Blood and lymphatic system disorders | Thymoglobulin + Cyclosporin | 13 | 48 | 13 |
| other | Elevated Uric Acid | Metabolism and nutrition disorders | Thymoglobulin + Cyclosporin | 7 | 48 | 7 |
| other | Rash | Skin and subcutaneous tissue disorders | Thymoglobulin + Cyclosporin | 7 | 48 | 7 |
| other | Fatigue | General disorders | Thymoglobulin + Cyclosporin | 6 | 48 | 6 |
| other | Low Magnesium | Metabolism and nutrition disorders | Thymoglobulin + Cyclosporin | 6 | 48 | 6 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Thymoglobulin + Cyclosporin | ||
| Total, other adverse events | Thymoglobulin + Cyclosporin | 48 | 48 |
| Total, serious adverse events | Thymoglobulin + Cyclosporin | 8 | 48 |
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/NCT00806598
GET https://conductscience.org/api/trials/v1/NCT00806598/events?page=2