Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab

Recruiting now · Phase 2

Conditions studied: Hematologic Malignancies

In brief

This extension study is designed to enroll participants with hematologic malignancies who are receiving clinical benefit from tafasitamab treatment in a parent study with tafasitamab..

Key facts

Study ID

NCT06465433

Run by

Incyte Corporation

People needed

25

Starts

2022-11-08

Expected to finish

2027-08-29

Last updated by the study team

2025-12-10

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Having been enrolled and is still receiving treatment with tafasitamab at the end of a parent tafasitamab clinical study.
• Is tolerating tafasitamab treatment at the dose specified in the parent protocol as assessed by the Investigator.
• Is in complete/partial response or stable disease and is receiving clinical benefit from treatment with tafasitamab in the parent study, as assessed by the Investigator.
• Has demonstrated compliance, as assessed by the Investigator, with the parent protocol requirements.
• Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this protocol.

You may not qualify if…

• Patient who is legally institutionalized, or under judicial protection.
• Has met one or more criteria for permanent tafasitamab treatment discontinuation as stipulated in the parent protocol.
• Able to access tafasitamab outside a clinical study.
• Patient with an uncontrolled intercurrent illness or any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol.
• A female patient who is pregnant confirmed by a pregnancy test prior to enrollment, breastfeeding, or a woman of childbearing potential (WOCBP) who does not agree to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of study treatment, and does not refrain from donating oocytes during this period.
• A male patient who does not agree to use contraception as detailed in the contraceptive guidance during the treatment period and for at least 3 months after the last dose of study treatment (if they have a heterosexual partner who is a woman of childbearing potential) and who does not refrain from donating sperm during this period.

Where it is running

• Petz Aladar County Teaching Hospital — Győr, Hungary (enrolling)
• Samsung Medical Center — Seoul, South Korea (enrolling)
• Gazi University Hospital Gazi University Faculty of Medicine — Ankara, Turkey (Türkiye) (enrolling)
• Hospital S.M. Terni University of Perugia — Terni, Italy
• Clinica Universitad de Navarra — Pamplona, Spain

Full record on ClinicalTrials.gov

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