NCT06465433 Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab
| NCT ID | NCT06465433 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Incyte Corporation |
| Condition | Hematologic Malignancies |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2022-11-08 |
| Primary Completion | 2027-08-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 25 participants in total. It began in 2022-11-08 with a primary completion date of 2027-08-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 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.
Contact & Investigator
Incyte Medical Director
STUDY DIRECTOR
Incyte Corporation
Frequently Asked Questions
Who can join the NCT06465433 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Hematologic Malignancies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06465433 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06465433 currently recruiting?
Yes, NCT06465433 is actively recruiting participants. Contact the research team at medinfo@incyte.com for enrollment information.
Where is the NCT06465433 trial being conducted?
This trial is being conducted at Győr, Hungary, Terni, Italy, Seoul, South Korea, Pamplona, Spain and 1 additional location.
Who is sponsoring the NCT06465433 clinical trial?
NCT06465433 is sponsored by Incyte Corporation. The principal investigator is Incyte Medical Director at Incyte Corporation. The trial plans to enroll 25 participants.