Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc)
This study has been terminated.
(inactive)
Sponsor:
Columbia University
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT00684255
First received: May 22, 2008
Last updated: August 11, 2011
Last verified: August 2011
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Results First Received: December 22, 2008
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Conditions: |
Systemic Lupus Erythematosus Systemic Sclerosis |
| Interventions: |
Procedure: Reduced Intensity Allogeneic Transplant Drug: Fludarabine Drug: Busulfan Drug: Campath |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Study closed due to low accrual. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Reduced Intensity Regimen SLE | Reduced Intensity Regimen of Fludarabine/Busulfan and Campath Followed by alloSCT for Refractory Systemic Lupus Erythematosus (SLE) |
| Reduced Intensity Regimen SSc | Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc) |
Participant Flow: Overall Study
| Reduced Intensity Regimen SLE | Reduced Intensity Regimen SSc | |
|---|---|---|
| STARTED | 0 | 1 |
| COMPLETED | 0 | 1 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Reduced Intensity Regimen SLE | Reduced Intensity Regimen of Fludarabine/Busulfan and Campath Followed by alloSCT for Refractory Systemic Lupus Erythematosus (SLE) |
| Reduced Intensity Regimen SSc | Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc) |
| Total | Total of all reporting groups |
Baseline Measures
| Reduced Intensity Regimen SLE | Reduced Intensity Regimen SSc | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
0 | 1 | 1 |
|
Age, Customized
[units: Participants] |
|||
| Ages 0-7 | 0 | 0 | 0 |
| Ages 8-17 | 0 | 1 | 1 |
| Ages 18-65 | 0 | 0 | 0 |
|
Gender
[units: participants] |
|||
| Female | 0 | 1 | 1 |
| Male | 0 | 0 | 0 |
|
Region of Enrollment
[units: participants] |
|||
| United States | 0 | 1 | 1 |
Outcome Measures
| 1. Primary: | Toxicity Associated With Reduced Intensity Regimen of Fludarabine/Busulfan and Campath Followed by alloSCT is to be Determined. [ Time Frame: 1 year ] |
| 2. Secondary: | Chimerism [ Time Frame: 1 year ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
No
| 3. Secondary: | Immune Reconstitution. [ Time Frame: 1 year ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
No
| 4. Secondary: | Progression Free and Overall Survival. [ Time Frame: 1 year ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
No
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| Study closed due to low accrual. Did not meet enrollment goals. |
Results Point of Contact:
Name/Title: Dr. Mitchell S. Cairo
Organization: Columbia University
phone: 212-305-8316
e-mail: mc1310@columbia.edu
Organization: Columbia University
phone: 212-305-8316
e-mail: mc1310@columbia.edu
No publications provided
| Responsible Party: | Mitchell S. Cairo, MD/ Principal Investigator, Columbia University |
| ClinicalTrials.gov Identifier: | NCT00684255 History of Changes |
| Other Study ID Numbers: | AAAB1324, CHNY-01-511 |
| Study First Received: | May 22, 2008 |
| Results First Received: | December 22, 2008 |
| Last Updated: | August 11, 2011 |
| Health Authority: | United States: Food and Drug Administration |