BridgeMD
A continued study in patients with Hematologic Cancers previously treated with Tafasitamab.
EU CTIS ID: 2022-500765-27-00
What this study is testing
To provide continued treatment and evaluation of safety in patients receiving tafasitamab.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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 MorphoSys/Incyte-sponsored 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 likely can't join 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) (as defined in Appendix 5: Contraceptive Guidance and Collection of Pregnancy Information) who does not agree to follow the contraceptive guidance in Appendix 5: Contraceptive Guidance and Collection of Pregnancy Information 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 Appendix 5: Contraceptive Guidance and Collection of Pregnancy Information 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.