Campath-1h Phase I/II Pilot Trial as Immunoablative Therapy for Refractory Systemic Sclerosis (CAMPATH-1H)
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|ClinicalTrials.gov Identifier: NCT01639573|
Recruitment Status : Recruiting
First Posted : July 12, 2012
Last Update Posted : January 25, 2018
|Condition or disease||Intervention/treatment|
Patients, 8 to18 years of age, will be included if they have a proven diagnosis of diffuse cutaneous or systemic SSc as defined by the ACR criteria with evidence of active inflammatory disease Plus at least 1 of the following:SSc-related pulmonary disease with forced vital capacity (FVC) or hemoglobin-adjusted DLCO < 70% and evidence of alveolitis by high-resolution CT scan or bronchoalveolar lavage.
OR:History of SSc-related renal crisis or disease, not active at the time of screening
OR:Moderate to severe upper and/or lower gastrointestinal involvement
AND:Unacceptable toxicity or steroid dependence > 0.3 mg/kg/d,
OR:Failure to respond to, or unacceptable toxicity of MTX > 1mg/kg in combination with cyclosporine or azathioprine or cyclophosphamide 2 kg/d or Rituximab 375 mg/m2 x 4 doses or Imatinib 800 mg/
OR:Disease recurrence after tapering medication above
|Study Type :||Observational|
|Estimated Enrollment :||3 participants|
|Official Title:||Campath-1h as Immunoablative Therapy for Children and Adolescents With Treatment Refractory Systemic Sclerosis|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
- Drug: Campath
Pediatric patients with dcSSc are eligible for the clinical trial if they fulfill the inclusion and exclusion criteria of the trial. The inclusion and exclusion criteria are based upon those of the SCOT trial for adult dcSSc patients, which is the Phase 3 clinical trial in the United States comparing autologous HSCT to monthly high dose cyclophosphamide (CY) alone.
- Primary outcome [ Time Frame: 2 years ]To determine why the extended administration of Campath-1H results in immune ablation in some patients and immunosuppression in others, Number of Participants with Adverse Events as a Measure of Safety and Tolerability Campath-1H antibody levels during and after the completion of the Campath administration. (47) Thus, both the peak Campath-1H levels as well as the duration of circulating Campath will be determined.
- Campath [ Time Frame: The site will follow patients for 6 months post adverse event. ]Number of Participants with Adverse Events as a Measure of Safety and Tolerability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639573
|United States, California|
|Childrens Hospitla Los Angeles||Recruiting|
|Los Angeles, California, United States, 90027|
|Contact: Andreas O Reiff, MD 323-361-4178 ext 4178 firstname.lastname@example.org|
|Contact: Ana A Cabrera, BA 323 361-4178 ext 4178 email@example.com|
|Principal Investigator: Andreas O Reiff, MD|
|Principal Investigator:||Andreas Reiff, MD||CHLA|