Overview
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..
Eligibility
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.