CompletedNot Applicable

Retrospective Study Assessing the Effect of Avapritinib Versus Best Available Therapy in Patients With AdvSM

United States, Austria, Germany317 participantsStarted 2020-12-02

Plain-language summary

BLU-285-2405 is a multi-center, synthetic control, observational and retrospective study designed to compare clinical outcomes for avapritinib compared with best available therapy for patients with AdvSM.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Diagnosed with AdvSM, with known subtype including SM-AHN, ASM, or MCL
✓. Received at least one line of systemic therapy for AdvSM, which may include but not limited to regimens containing:
✓. Adult (≥18 years of age) at the initiation of first systemic line of therapy at the participating site
✓. Had an index date at least 3 months prior to the start of data collection (in order to include patients with at least 3 months of follow-up after index date), unless date of death occurred less than three months from index date
✓. Had an approved waiver of informed consent or signed informed consent for participation in the retrospective chart review study, if no institutional waiver from the site was granted

Exclusion criteria

✕. Malignancy that is not in remission at time of SM diagnosis, or new non-hematological malignancy diagnosed after SM diagnosis, except for: completely resected basal cell and squamous cell skin cancer, curatively treated localized prostate cancer, and completely resected carcinoma in situ of any site
✕. Among patients with SM-AHN, presence of either of the following:
✕. Received avapritinib as the first line of systemic therapy for AdvSM at participating site, or prior to initiation of first systemic therapy at participating site.

What they're measuring

Comparative evaluation of overall survival (OS) between patients receiving best available therapy versus avapritinib in BU-285-2101 and BLU-285-2202

Timeframe: up to 12 years

Trial details

NCT IDNCT04695431

SponsorBlueprint Medicines Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-10-04

View on ClinicalTrials.gov More Advanced Systemic Mastocytosis trials