Health Trials

A Non-interventional Study of Participants With BPDCN Treated With Chemotherapy

ConditionBlastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorStemline Therapeutics, Inc.

About this trial

The main goal of this study is to investigate the effectiveness and safety of chemotherapy agents in the treatment of participants with BPDCN and to provide comparator arm data to the prospective ELZONRIS registry study (STML-401-0521).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Alive, deceased, or unreachable participants (as permitted by local regulation), aged ≥18 years at the start of first-line treatment for BPDCN, and treated with chemotherapy regimens (at a minimum) as first-line treatment for BPDCN from May 2016

Diagnosed with BPDCN, based on clinical, laboratory, and imaging (where performed per institutional practice) assessments, with a demonstration of a specific immunophenotype (either by immunohistochemistry or flow cytometry), particularly CD4, CD56, and CD123

Participants (or their legally authorized representatives) who have signed the informed consent and privacy form, where required as per local regulation

Disqualifiers

Participant has received an investigational agent as first-line therapy for BPDCN

Participant has received first-line therapy for BPDCN in an interventional clinical trial

Trial population

Adult participants with BPDCN who have been treated with chemotherapy regimens (at a minimum) as first-line treatment from May 2016 at sites in Europe.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Chemotherapy

    Drug

    Several chemotherapy regimens can be considered (acute myeloid leukemia-like, acute lymphocytic leukemia-like, lymphoma-like). The choice of the regimen, as well as dosing and schedules, are based on the institution's and the health care provider's preferences. No study medication will be provided by the sponsor during this study.

Treatment groups

140 Participants
are divided into 1 treatment group
Group A: Chemotherapy1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate

Time frame
Baseline through Month 18
2

Composite Compete Response

Time frame
Baseline through Month 18
3

Number of Participants Bridged to Stem Cell Transplant

Time frame
Baseline through Month 18
4

Duration of Response

Time frame
Baseline through Month 18

Secondary outcomes

1

Time to Next Treatment

Time frame
Baseline through Month 26
2

Number of Different First-line Treatment Regimens and Sequences Received

Time frame
Baseline through Month 26

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stemline Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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