Continued treatment for patients with blood cancers using tafasitamab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This extension study aims to provide ongoing treatment with tafasitamab for patients with hematologic malignancies who have previously shown clinical benefit in a parent study. Participants must have been enrolled in the initial tafasitamab study and be experiencing a complete or partial response, or stable disease. The study focuses on ensuring that patients who are tolerating the treatment can continue to receive it, thereby potentially improving their outcomes. Regular assessments will be conducted to monitor compliance and response to the treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

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

Study contacts

• Study coordinator: Incyte Corporation Call Center (US)
• Email: medinfo@incyte.com
• Phone: 1.855.463.3463

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.