Continued treatment for patients with blood cancers using tafasitamab
An Open-Label, Multicenter, Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab
This study is testing if continuing treatment with tafasitamab can help patients with blood cancers who have already seen some improvement from the medication.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Incyte Corporation Industry-sponsored |
| Drugs / interventions | tafasitamab |
| Locations | 5 sites (Győr and 4 other locations) |
| Trial ID | NCT06465433 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with hematologic malignancies who are currently benefiting from tafasitamab treatment in a parent study.
Not a fit: Patients who have not previously participated in tafasitamab studies or those who have not responded to the treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer sustained treatment options for patients with hematologic malignancies, potentially improving their quality of life and outcomes.
How similar studies have performed: Other studies involving tafasitamab have shown promise in treating hematologic malignancies, indicating that this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Győr and 4 other locations
- Petz Aladar County Teaching Hospital — Győr, Hungary (Recruiting)
- Hospital S.M. Terni University of Perugia — Terni, Italy (Completed)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
- Clinica Universitad de Navarra — Pamplona, Spain (Completed)
- Gazi University Hospital Gazi University Faculty of Medicine — Ankara, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Incyte Corporation Call Center (US)
- Email: medinfo@incyte.com
- Phone: 1.855.463.3463
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.