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Nonmyeloablative Conditioning and Transplantation for Patients With Refractory Systemic Lupus Erythematosus (SLE)
Phase 1, PHASE2 trial testing Cyclophosphamide in Lupus Erythematosus in 1 participant. Terminated before completion.
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 13 September 2016 |
| Primary completion | 28 March 2017 |
| Estimated completion | 29 March 2017 |
| Sites | 1 location across United States |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →
Adults 18 to 75, any sex, with Lupus Erythematosus or Graft-versus-host Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of participants who were alive at 1 year after transplant and who had not suffered graft rejection, acute or chronic GVHD, or Grade 3 or higher (CTCAE V4.0) adverse events.
| Group | Value | 95% CI |
|---|---|---|
| Nonmyeloablative Conditioning and BMT | 1 |
Number of patients alive and alive without relapse, respectively.
| Group | Value | 95% CI |
|---|---|---|
| Nonmyeloablative Conditioning and BMT | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Nonmyeloablative Conditioning and BMT | 1 |
Number of participants with primary and/or secondary graft failure.
| Group | Value | 95% CI |
|---|---|---|
| Nonmyeloablative Conditioning and BMT | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Nonmyeloablative Conditioning and BMT | 0 |
Percentage of participants who developed grades II-IV and grades III-IV acute GVHD. Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade I (skin involvement stages 1+ to 2+, with no liver or GI involvement), Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvem
| Group | Value | 95% CI |
|---|---|---|
| Nonmyeloablative Conditioning and BMT | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Nonmyeloablative Conditioning and BMT | 0 |
Percentage of participants who developed chronic GVHD as defined by the NIH consensus criteria. This system gives scores from 0 to 3 for Karnofsky performance score, skin, mouth, eyes, gastrointestinal, liver, lungs, joints, and genitals, as well as an overall severity (mild, moderate, or severe). Mild chronic GVHD involves only 1 or 2 organs or sites (except the lung), with no clinically significant functional impairment (maximum of score 1 in all affected organs or sites). Moderate chronic GVHD involves 1) at least 1 organ or site with clinically significant but no major disability (maximu
| Group | Value | 95% CI |
|---|---|---|
| Nonmyeloablative Conditioning and BMT | 0 |
The main goal of the study is to determine if bone marrow transplant (BMT) from a less specific pool of donors in combination with high dose cyclophosphamide can induce remission of refractory systemic lupus erythematosus.
No peer-reviewed publications indexed yet for this trial.
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