Trial · NCT00065260
Rabbit Antithymocyte Globulin Versus Campath-1H for Treating Severe Aplastic Anemia
NCT00065260, Phase 2, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2016-03-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rabbit Antithymocyte Globulin Versus Campath-1H for Treating Severe Aplastic Anemia. Trials, record NCT00065260. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00065260
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rabbit Antithymocyte Globulin Versus Campath-1H for Treating Severe Aplastic Anemia
- NCT number
- NCT00065260
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Aplastic Anemia
- Interventions
- Campath-1H, r-ATG, CsA
- First posted
- 2003-07-21
- Last updated
- 2021-07-21
- Results first posted
- 2016-03-03
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants no Longer Meeting Criteria for Severe Aplastic Anemia. | 6 months | Number of participants no longer meeting the criteria for severe aplastic anemia as measured by response to treatment at 6 months |
| Secondary | Number of Participants With Robust Hematologic Recovery With Reticulocyte or Platelet Count | 6 months | Number of participants with robust hematologic recovery with reticulocyte or platelet count ≥ 50,000/uL |
| Secondary | Percentage of Cumulative Incidence of Relapse in Participants | 3 year | Percentage of cumulative incidence of relapse of disease in participants |
| Secondary | Percentage of Cumulative Incidence of Clonal Evolution in Participants | 3 years | Percent of cumulative incidence of clonal evolution in participants to either paroxysmal nocturnal hemoglobinuria (PNH), myelodysplasia or acute leukemia. |
| Secondary | Percentage of Participants no Longer Meeting Criteria for Severe Aplastic Anemia. | 3 months and 6 months | Percentage of participants no longer meeting the criteria for severe aplastic anemia as measured by response to treatment |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants no Longer Meeting Criteria for Severe Aplastic Anemia. | 6 months | 1 patient was not evaluable at 6 months in the alemtuzumab arm because of a single early death from infectious complications | participants | NUMBER |
| SECONDARY | Number of Participants With Robust Hematologic Recovery With Reticulocyte or Platelet Count | 6 months | 1 patient was not evaluable at 6 months in the alemtuzumab arm because of a single early death from infectious complications | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Cumulative Incidence of Relapse in Participants | 3 year | 1 participants was not evaluable at 6 months in the alemtuzumab arm because of a single early death from infectious complications. | percentage of cumulative incidence | NUMBER |
| SECONDARY | Percentage of Cumulative Incidence of Clonal Evolution in Participants | 3 years | 1 participant was not evaluable at 6 months in the alemtuzumab arm because of a single early death from infectious complications | Percentage of Cumulative Incidence | NUMBER |
| SECONDARY | Percentage of Participants no Longer Meeting Criteria for Severe Aplastic Anemia. | 3 months and 6 months | 1 patient was not evaluable at 6 months in the alemtuzumab arm because of a single early death from infectious complications | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants no Longer Meeting Criteria for Severe Aplastic Anemia. | r-ATG /Cyclosporine | No Response | 18 | participants | |
| Participants no Longer Meeting Criteria for Severe Aplastic Anemia. | Alemtuzumab (Campath-1H) | No Response | 17 | participants | |
| Participants no Longer Meeting Criteria for Severe Aplastic Anemia. | r-ATG /Cyclosporine | Partial Response | 9 | participants | |
| Participants no Longer Meeting Criteria for Severe Aplastic Anemia. | Alemtuzumab (Campath-1H) | Partial Response | 9 | participants | |
| Participants no Longer Meeting Criteria for Severe Aplastic Anemia. | r-ATG /Cyclosporine | Complete Response | 0 | participants | |
| Participants no Longer Meeting Criteria for Severe Aplastic Anemia. | Alemtuzumab (Campath-1H) | Complete Response | 0 | participants | |
| Number of Participants With Robust Hematologic Recovery With Reticulocyte or Platelet Count | r-ATG /Cyclosporine | 9 | Participants | ||
| Number of Participants With Robust Hematologic Recovery With Reticulocyte or Platelet Count | Alemtuzumab (Campath-1H) | 9 | Participants | ||
| Percentage of Cumulative Incidence of Relapse in Participants | r-ATG /Cyclosporine | 19 | percentage of cumulative incidence | ||
| Percentage of Cumulative Incidence of Relapse in Participants | Alemtuzumab (Campath-1H) | 9 | percentage of cumulative incidence |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | r-ATG /Cyclosporine | 27 | |
| Overall Study | STARTED | Alemtuzumab (Campath-1H) | 27 | |
| Overall Study | COMPLETED | r-ATG /Cyclosporine | 27 | |
| Overall Study | COMPLETED | Alemtuzumab (Campath-1H) | 26 | |
| Overall Study | NOT COMPLETED | r-ATG /Cyclosporine | 0 | |
| Overall Study | NOT COMPLETED | Alemtuzumab (Campath-1H) | 1 |
Source ClinicalTrials.gov
Adverse events4
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 | infection | Blood and lymphatic system disorders | r-ATG /Cyclosporine | 7 | 27 | 7 |
| other | infection | Blood and lymphatic system disorders | Alemtuzumab (Campath-1H) | 12 | 27 | 12 |
| serious | infection | Immune system disorders | r-ATG /Cyclosporine | 7 | 27 | 7 |
| serious | infection | Immune system disorders | Alemtuzumab (Campath-1H) | 12 | 27 | 12 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | r-ATG /Cyclosporine | 9 | 27 |
| Total, all-cause mortality | Alemtuzumab (Campath-1H) | 4 | 27 |
| Total, other adverse events | r-ATG /Cyclosporine | 7 | 27 |
| Total, other adverse events | Alemtuzumab (Campath-1H) | 12 | 27 |
| Total, serious adverse events | r-ATG /Cyclosporine | 7 | 27 |
| Total, serious adverse events | Alemtuzumab (Campath-1H) | 12 | 27 |
Source ClinicalTrials.gov
Papers4
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| r-ATG /Cyclosporine vs Alemtuzumab (Campath-1H): deaths from any cause | Trial comparisons |
| r-ATG /Cyclosporine vs Alemtuzumab (Campath-1H): Number of Participants With Robust Hematologic Recovery With Reticulocyte or Platelet Count | Trial comparisons |
| r-ATG /Cyclosporine vs Alemtuzumab (Campath-1H): serious adverse events | Trial comparisons |
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/NCT00065260
GET https://conductscience.org/api/trials/v1/NCT00065260/registered