Trial · NCT00229619
Rituximab to Treat Moderate Aplastic Anemia, Pure Red Cell Aplasia, or Diamond Blackfan Anemia
NCT00229619, Phase 2, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2014-07-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rituximab to Treat Moderate Aplastic Anemia, Pure Red Cell Aplasia, or Diamond Blackfan Anemia. Trials, record NCT00229619. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00229619
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rituximab to Treat Moderate Aplastic Anemia, Pure Red Cell Aplasia, or Diamond Blackfan Anemia
- NCT number
- NCT00229619
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Anemia, Aplastic, Red-Cell Aplasia, Pure, Anemia, Diamond-Blackfan
- Interventions
- Rituximab
- First posted
- 2005-09-29
- Last updated
- 2018-09-18
- Results first posted
- 2014-07-28
- Limitations and caveats
- Study was terminated early due to slow accrual. Conclusions on efficacy limited by small sample size.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response to Rituximab | 6 months | Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses. Primary endpoint will determine immune response by evaluating changes in peripheral blood counts (platelets, absolute neutrophil count, reticulocyte count, hemoglobin) and transfusion requirements at 6 months. The response wil be will be categorized as complete, partial or no response. Subjects will be categorized as complete responders if their blood counts return to normal. Subjects will categorized as partial responders if there is an improvement in 2 or 3 of the depressed baseline blood counts. |
| Secondary | Response Assessment at 3 Months | 3 months | |
| Secondary | Response Rates at 12 Months (After the First Dose of Study Med) | 12 months |
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 | Response to Rituximab | 6 months | participants | NUMBER | |
| SECONDARY | Response Assessment at 3 Months | 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Response Rates at 12 Months (After the First Dose of Study Med) | 12 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response to Rituximab | Rituximab Subjects | Complete response | 0 | participants | |
| Response to Rituximab | Rituximab Subjects | Partial response | 2 | participants | |
| Response to Rituximab | Rituximab Subjects | No Response | 9 | participants | |
| Response Assessment at 3 Months | Rituximab (Rituxan) | Complete response | 0 | Participants | |
| Response Assessment at 3 Months | Rituximab (Rituxan) | Partial response | 1 | Participants | |
| Response Assessment at 3 Months | Rituximab (Rituxan) | No response | 10 | Participants | |
| Response Rates at 12 Months (After the First Dose of Study Med) | Rituximab Treated Subjects | Complete response | 0 | Participants | |
| Response Rates at 12 Months (After the First Dose of Study Med) | Rituximab Treated Subjects | Partial response | 3 | Participants | |
| Response Rates at 12 Months (After the First Dose of Study Med) | Rituximab Treated Subjects | Relapse after response | 1 | Participants | |
| Response Rates at 12 Months (After the First Dose of Study Med) | Rituximab Treated Subjects | No response | 7 | 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 | Rituximab Treated Subjects | 11 | |
| Overall Study | COMPLETED | Rituximab Treated Subjects | 11 | |
| Overall Study | NOT COMPLETED | Rituximab Treated Subjects | 0 |
Source ClinicalTrials.gov
Adverse events41
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 | Bleeding | Blood and lymphatic system disorders | Rituximab Subjects | 1 | 11 | |
| other | Bruising | Blood and lymphatic system disorders | Rituximab Subjects | 1 | 11 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Rituximab Subjects | 1 | 11 | |
| other | Cytokine release syndrome/ acute infusion reaction | General disorders | Rituximab Subjects | 1 | 11 | |
| other | Pain | General disorders | Rituximab Subjects | 2 | 11 | |
| other | Serum sickness | Immune system disorders | Rituximab Subjects | 1 | 11 | |
| other | Fatigue | General disorders | Rituximab Subjects | 1 | 11 | |
| other | Urinary Tract Infection | Infections and infestations | Rituximab Subjects | 1 | 11 | |
| other | Mouth sores | Gastrointestinal disorders | Rituximab Subjects | 1 | 11 | |
| other | Headache | General disorders | Rituximab Subjects | 1 | 11 |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab Subjects | ||
| Total, other adverse events | Rituximab Subjects | 4 | 11 |
| Total, serious adverse events | Rituximab Subjects | 4 | 11 |
Source ClinicalTrials.gov
Papers3
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/NCT00229619
GET https://conductscience.org/api/trials/v1/NCT00229619/events?page=2