Trial · NCT00076752
Lymphocyte Depletion and Stem Cell Transplantation to Treat Severe Systemic Lupus Erythematosus
NCT00076752, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2014-06-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Lymphocyte Depletion and Stem Cell Transplantation to Treat Severe Systemic Lupus Erythematosus. Trials, record NCT00076752. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00076752
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lymphocyte Depletion and Stem Cell Transplantation to Treat Severe Systemic Lupus Erythematosus
- NCT number
- NCT00076752
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Lupus Erythematosus, Systemic
- Interventions
fludarabine phosphate, cyclophosphamide, Rituxan (rituximab), filgrastim, methylprednisolone, immunologic technique, laboratory biomarker analysis, autologous hematopoietic stem cell transplantation, Diphenhydramine, Mesna
- First posted
- 2004-02-03
- Last updated
- 2021-01-05
- Results first posted
- 2014-06-10
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Relapse-free Complete Clinical Response | 60 months | Complete clinical response is defined as complete clinical response in the target organ and no clinical signs of active lupus as determined by a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of ≤3; prednisone ≤10mg/day at 6 months and ≤5mg/day at 12 months or later. |
| Secondary | Number of Participants With Adverse Events | 18 months | Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. |
| Secondary | Anti-Nuclear Antibody | Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years. | Anti-Nuclear antibody is a well accepted biological clinical laboratory marker of systemic lupus. Range of normal values is 0-0.9 EU. |
| Secondary | Extractable Nuclear Antigen (ENA) | Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years. | Extractable nuclear antigen is a well accepted biological clinical laboratory marker of systemic lupus. Range of normal values is 0-19. |
| Secondary | Anti-Double Stranded Deoxyribonucleic Acid (DNA) Antibody | Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years. | Anti-Double stranded deoxyribonucleic acid antibody is a well accepted biological clinical laboratory marker especially specific for systemic lupus. Range of normal values is 0-24 IU. |
| Secondary | Anti-Smith-Ribonuclear Protein Antibody | Day -7, day 0, 1 3, and 6 months, 1 year, 18 months and 2 years. | Anti-Smith-Ribonuclear protein antibody is a well accepted biological clinical laboratory marker of systemic lupus.Range of normal values is 0-19 EU. |
| Secondary | White Blood Cells | Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years. | The white blood cell test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 3.4-9.6 K/uL. |
| Secondary | Absolute Neutrophil Count | Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years. | The absolute neutrophil count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 1.29-7.5 K/uL. |
| Secondary | Absolute Lymphocyte Count | Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years. | The absolute lymphocyte count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 0.45-4.9 K/uL. |
| Secondary | Platelet Count | Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years. | The platelet count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 162-380 K/uL. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Relapse-free Complete Clinical Response | 60 months | Ninth participant was taken off study before proceeding with transplant per principal investigator due to decision to put study on hold. | Months | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events | 18 months | participants | NUMBER | |
| SECONDARY | Anti-Nuclear Antibody | Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years. | One participant was enrolled but the study was closed before the patient could be treated. | EU | MEAN |
| SECONDARY | Extractable Nuclear Antigen (ENA) | Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years. | One participant was enrolled but the study was closed before the patient could be treated. | EU | MEAN |
| SECONDARY | Anti-Double Stranded Deoxyribonucleic Acid (DNA) Antibody | Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years. | One participant was enrolled but the study was closed before the patient could be treated. | IU | MEAN |
| SECONDARY | Anti-Smith-Ribonuclear Protein Antibody | Day -7, day 0, 1 3, and 6 months, 1 year, 18 months and 2 years. | One participant was enrolled but the study was closed before the patient could be treated. | EU | MEAN |
| SECONDARY | White Blood Cells | Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years. | One participant was enrolled but the study was closed before the patient could be treated. | K/uL | MEAN |
| SECONDARY | Absolute Neutrophil Count | Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years. | One participant was enrolled but the study was closed before the patient could be treated. | K/uL | MEAN |
| SECONDARY | Absolute Lymphocyte Count | Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years. | One participant was enrolled but the study was closed before the patient could be treated. | K/uL | MEAN |
| SECONDARY | Platelet Count | Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years. | One participant was enrolled but the study was closed before the patient could be treated. | K/uL | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group112
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Relapse-free Complete Clinical Response | Autologous HSCT in SLE | 54 | Full Range 36 to 60 | Months | |
| Number of Participants With Adverse Events | Autologous HSCT in SLE | 8 | participants | ||
| Anti-Nuclear Antibody | Autologous HSCT in SLE | Day -7 | 5.4 | Standard Deviation 4.65 | EU |
| Anti-Nuclear Antibody | Autologous HSCT in SLE | Day 0 | 4.7 | Standard Deviation 4.73 | EU |
| Anti-Nuclear Antibody | Autologous HSCT in SLE | 1 month | 3.7 | Standard Deviation 3.89 | EU |
| Anti-Nuclear Antibody | Autologous HSCT in SLE | 3 months | 3.2 | Standard Deviation 3.91 | EU |
| Anti-Nuclear Antibody | Autologous HSCT in SLE | 6 months | 2.7 | Standard Deviation 3.01 | EU |
| Anti-Nuclear Antibody | Autologous HSCT in SLE | 1 year | 2.6 | Standard Deviation 2.77 | EU |
| Anti-Nuclear Antibody | Autologous HSCT in SLE | 18 months | 2.8 | Standard Deviation 2.7 | EU |
| Anti-Nuclear Antibody | Autologous HSCT in SLE | 2 years | 2.5 | Standard Deviation 2.59 | EU |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Autologous HSCT in SLE | 9 | |
| Overall Study | COMPLETED | Autologous HSCT in SLE | 6 | |
| Overall Study | NOT COMPLETED | Autologous HSCT in SLE | 3 |
Source ClinicalTrials.gov
Adverse events140
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 | Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | Autologous HSCT in SLE | 1 | 9 | 1 |
| other | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | Autologous HSCT in SLE | 1 | 9 | 1 |
| other | Auditory/Ear - Other (Specify, __) | Ear and labyrinth disorders | Autologous HSCT in SLE | 1 | 9 | 1 |
| other | Blood/Bone Marrow - Other (Specify, __) | Blood and lymphatic system disorders | Autologous HSCT in SLE | 1 | 9 | 2 |
| other | Bone marrow cellularity | Blood and lymphatic system disorders | Autologous HSCT in SLE | 1 | 9 | 1 |
| other | Hemoglobin | Blood and lymphatic system disorders | Autologous HSCT in SLE | 8 | 9 | 55 |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Autologous HSCT in SLE | 8 | 9 | 82 |
| other | Lymphopenia | Blood and lymphatic system disorders | Autologous HSCT in SLE | 8 | 9 | 79 |
| other | Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | Autologous HSCT in SLE | 8 | 9 | 81 |
| other | Platelets | Blood and lymphatic system disorders | Autologous HSCT in SLE | 8 | 9 | 130 |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Autologous HSCT in SLE | 2 | 9 |
| Total, other adverse events | Autologous HSCT in SLE | 8 | 9 |
| Total, serious adverse events | Autologous HSCT in SLE | 8 | 9 |
Source ClinicalTrials.gov
Papers5
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/NCT00076752
GET https://conductscience.org/api/trials/v1/NCT00076752/results?page=2