Trial · NCT00260689
Three Immunosuppressive Treatment Regimens for Severe Aplastic Anemia
NCT00260689, Phase 2, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2017-06-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Three Immunosuppressive Treatment Regimens for Severe Aplastic Anemia. Trials, record NCT00260689. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00260689
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Three Immunosuppressive Treatment Regimens for Severe Aplastic Anemia
- NCT number
- NCT00260689
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 136 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Immunosuppresion, Thrombocytopenia, Pancytopenia, Neutropenia
- Interventions
- Anti-thymocyte globulin (rabbit), Anti-thymocyte globulin (horse), Cyclosporine, Alemtuzumab
- First posted
- 2005-12-01
- Last updated
- 2017-06-08
- Results first posted
- 2017-06-08
- Limitations and caveats
Originally, there were 3 regimens: h-ATG/CsA ; r-ATG/CsA; alemtuzumab. Subjects not responding to r-ATG will cross over to alemtuzumab, and subjects failing alemtuzumab will cross over to r-ATG. Subjects not responding to h-ATG/CsA will go off study.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hematologic Response | 3 months | Hematologic response is defined as subjects having blood counts no longer meeting the standard ("Camitta") criteria for severe pancytopenia in Severe Aplastic Anemia, equivalent to 2 of the following values obtained on 2 serial blood count measurements at least one week apart at landmark time points (3, 6 and 12 months) * Absolute neutrophil count \> 500/ μL * Platelet count \> 20,000/ μL * Reticulocyte count \> 60,000/ μL Improvement in counts that are dependent upon exogenously administered growth factors or transfusion will not be considered as fulfilling response criteria. |
| Primary | Hematologic Response | 6 months | Hematologic response is defined as subjects having blood counts no longer meeting the standard ("Camitta") criteria for severe pancytopenia in Severe Aplastic Anemia, equivalent to 2 of the following values obtained on 2 serial blood count measurements at least one week apart at landmark time points (3, 6 and 12 months) * Absolute neutrophil count \> 500/ μL * Platelet count \> 20,000/ μL * Reticulocyte count \> 60,000/ μL Improvement in counts that are dependent upon exogenously administered growth factors or transfusion will not be considered as fulfilling response criteria. |
| Primary | Hematologic Response | 12 months | Hematologic response is defined as subjects having blood counts no longer meeting the standard ("Camitta") criteria for severe pancytopenia in Severe Aplastic Anemia, equivalent to 2 of the following values obtained on 2 serial blood count measurements at least one week apart at landmark time points (3, 6 and 12 months) * Absolute neutrophil count \> 500/ μL * Platelet count \> 20,000/ μL * Reticulocyte count \> 60,000/ μL Improvement in counts that are dependent upon exogenously administered growth factors or transfusion will not be considered as fulfilling response criteria. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Hematologic Response | 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Hematologic Response | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Hematologic Response | 12 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Hematologic Response | Horse ATG/CsA Taper | 38 | Participants | ||
| Hematologic Response | Rabbit ATG/CsA | 20 | Participants | ||
| Hematologic Response | Alemtuzumab | 3 | Participants | ||
| Hematologic Response | Horse ATG/CsA Taper | 41 | Participants | ||
| Hematologic Response | Rabbit ATG/CsA | 22 | Participants | ||
| Hematologic Response | Alemtuzumab | 3 | Participants | ||
| Hematologic Response | Horse ATG/CsA Taper | 40 | Participants | ||
| Hematologic Response | Rabbit ATG/CsA | 18 | Participants | ||
| Hematologic Response | Alemtuzumab | 2 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Horse ATG/CsA Taper | 60 | |
| Overall Study | STARTED | Rabbit ATG/CsA | 60 | |
| Overall Study | STARTED | Alemtuzumab | 16 | |
| Overall Study | COMPLETED | Horse ATG/CsA Taper | 19 | |
| Overall Study | COMPLETED | Rabbit ATG/CsA | 11 | |
| Overall Study | COMPLETED | Alemtuzumab | 1 | |
| Overall Study | NOT COMPLETED | Horse ATG/CsA Taper | 41 | |
| Overall Study | NOT COMPLETED | Rabbit ATG/CsA | 49 | |
| Overall Study | NOT COMPLETED | Alemtuzumab | 15 |
Source ClinicalTrials.gov
Adverse events546
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 | edema | Blood and lymphatic system disorders | Horse ATG/CsA Taper | 0 | 60 | |
| other | edema | Blood and lymphatic system disorders | Rabbit ATG/CsA | 1 | 60 | |
| other | edema | Blood and lymphatic system disorders | Alemtuzumab | 0 | 16 | |
| other | edema - mild lower extremity | Blood and lymphatic system disorders | Horse ATG/CsA Taper | 1 | 60 | |
| other | edema - mild lower extremity | Blood and lymphatic system disorders | Rabbit ATG/CsA | 0 | 60 | |
| other | edema - mild lower extremity | Blood and lymphatic system disorders | Alemtuzumab | 0 | 16 | |
| other | gingival hypertrophy | Blood and lymphatic system disorders | Horse ATG/CsA Taper | 0 | 60 | |
| other | gingival hypertrophy | Blood and lymphatic system disorders | Rabbit ATG/CsA | 1 | 60 | |
| other | gingival hypertrophy | Blood and lymphatic system disorders | Alemtuzumab | 0 | 16 | |
| other | Hemolysis | Blood and lymphatic system disorders | Horse ATG/CsA Taper | 1 | 60 |
1 to 10 of 546Source ClinicalTrials.gov
See all 546 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Horse ATG/CsA Taper | 11 | 60 |
| Total, all-cause mortality | Rabbit ATG/CsA | 18 | 60 |
| Total, all-cause mortality | Alemtuzumab | 7 | 16 |
| Total, other adverse events | Horse ATG/CsA Taper | 36 | 60 |
| Total, other adverse events | Rabbit ATG/CsA | 39 | 60 |
| Total, other adverse events | Alemtuzumab | 15 | 16 |
| Total, serious adverse events | Horse ATG/CsA Taper | 7 | 60 |
| Total, serious adverse events | Rabbit ATG/CsA | 11 | 60 |
| Total, serious adverse events | Alemtuzumab | 6 | 16 |
Source ClinicalTrials.gov
Papers11
The papers the trial lists on ClinicalTrials.gov.
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/NCT00260689
GET https://conductscience.org/api/trials/v1/NCT00260689/events?page=2