S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis
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|ClinicalTrials.gov Identifier: NCT03499808|
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : August 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Amorphous, Eosinophilic, and Acellular Deposit Constipation Diarrhea Early Satiety Gastrointestinal Hemorrhage Hepatomegaly Lymphadenopathy Macroglossia Nausea Primary Systemic Amyloidosis Purpura Recurrent Primary Amyloidosis Refractory Primary Amyloidosis||Biological: Isatuximab Other: Laboratory Biomarker Analysis||Phase 2|
I. To assess the efficacy as measured by the confirmed overall hematologic response rate (partial response or better) of isatuximab in relapsed/refractory systemic light chain (AL) amyloidosis.
I. To evaluate toxicities in the treatment of relapsed/refractory AL amyloidosis with isatuximab.
II. To evaluate time to hematologic response. III. To evaluate duration of response. IV. To evaluate progression-free survival (PFS). V. To evaluate overall survival (OS).
I. To evaluate efficacy of isatuximab in relapsed/refractory immunoglobulin amyloid light chain (AL) amyloidosis as measured by organ specific response rates (cardiac, renal, gastrointestinal [GI], liver, soft tissue, nerve), in the subset of patients that can be evaluated for organ response.
II. To evaluate time to organ response in the subset of patients that can be evaluated for organ response.
Patients receive isatuximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up within 30 days and then every at least every 6 months for up to 4 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Isatuximab (SAR650984) (NSC-795145) for Patients With Previously Treated AL Amyloidosis|
|Actual Study Start Date :||March 8, 2018|
|Estimated Primary Completion Date :||October 30, 2021|
|Estimated Study Completion Date :||July 31, 2025|
Experimental: Treatment (isatuximab)
Patients receive isatuximab IV on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Overall confirmed hematologic response rate [ Time Frame: Up to 4 years ]Will include partial response, very good partial response and complete response. Hematologic response will be reported with a binomial confidence interval.
- Incidence of adverse events [ Time Frame: Up to 4 years ]Will be evaluated using the Common Terminology Criteria for Adverse Events version 4.0. The maximum grade for each toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
- Organ response [ Time Frame: Up to 4 years ]Organ response will be evaluated in the subset of patients with evaluable organ involvement using current criteria. The proportion of patients with organ response will be estimated as the number of patients with documented organ response out of the number of patients with documented evaluable organ involvement at baseline.
- Overall survival [ Time Frame: From date of registration to date of death due to any cause, assessed up to 4 years ]Will be estimated using the Kaplan-Meier method.
- Progression free survival [ Time Frame: From date of registration to date of first documentation of progression, symptomatic deterioration, or death due to any cause, assessed up to 4 years ]Will be estimated using the Kaplan-Meier method.
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): NCT03499808
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|Principal Investigator:||Emma Scott||Southwest Oncology Group|