Trial · NCT00195624
Alemtuzumab to Treat Severe Aplastic Anemia
NCT00195624, Phase 2, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2019-08-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Alemtuzumab to Treat Severe Aplastic Anemia. Trials, record NCT00195624. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00195624
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Alemtuzumab to Treat Severe Aplastic Anemia
- NCT number
- NCT00195624
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Severe Aplastic Anemia, Refractory, Severe Aplastic Anemia, Relapse
- Interventions
- Alemtuzumab (Campath ), Cyclosporine
- First posted
- 2005-09-19
- Last updated
- 2020-07-07
- Results first posted
- 2019-08-02
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Hematological Response at 6 Months | 6 months | Hematological response is defined as no longer satisfying blood count criteria for Severe Aplastic Anemia. Patients were classified as responders if they met two of the following three criteria: ANC greater than 500/ mm'; platelet count greater than 20,000/mm3; and reticulocyte count greater than 40,000/mm3 (60,000/mm3 after January 1993). |
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 | Number of Participants With Hematological Response at 6 Months | 6 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Hematological Response at 6 Months | Refractory | 0 | Participants | ||
| Number of Participants With Hematological Response at 6 Months | Relapsed | 18 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Refractory | 5 | |
| Overall Study | STARTED | Relapsed | 42 | |
| Overall Study | COMPLETED | Refractory | 5 | |
| Overall Study | COMPLETED | Relapsed | 42 | |
| Overall Study | NOT COMPLETED | Refractory | 0 | |
| Overall Study | NOT COMPLETED | Relapsed | 0 |
Source ClinicalTrials.gov
Adverse events304
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 | Ecchymosis | Blood and lymphatic system disorders | Refractory | 0 | 5 | |
| other | Ecchymosis | Blood and lymphatic system disorders | Relapsed | 6 | 42 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Refractory | 0 | 5 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Relapsed | 1 | 42 | |
| other | Haemolysis | Blood and lymphatic system disorders | Refractory | 0 | 5 | |
| other | Haemolysis | Blood and lymphatic system disorders | Relapsed | 1 | 42 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Refractory | 0 | 5 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Relapsed | 14 | 42 | |
| other | Neutropenia | Blood and lymphatic system disorders | Refractory | 0 | 5 | |
| other | Neutropenia | Blood and lymphatic system disorders | Relapsed | 1 | 42 |
1 to 10 of 304Source ClinicalTrials.gov
See all 304 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Refractory | 5 | 5 |
| Total, all-cause mortality | Relapsed | 13 | 42 |
| Total, other adverse events | Refractory | 4 | 5 |
| Total, other adverse events | Relapsed | 42 | 42 |
| Total, serious adverse events | Refractory | 2 | 5 |
| Total, serious adverse events | Relapsed | 22 | 42 |
Source ClinicalTrials.gov
Papers7
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 |
|---|---|
| Refractory vs Relapsed: Number of Participants With Hematological Response at 6 Months | Trial comparisons |
| Refractory vs Relapsed: deaths from any cause | Trial comparisons |
| Refractory vs Relapsed: 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/NCT00195624
GET https://conductscience.org/api/trials/v1/NCT00195624/events?page=2