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Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab
RECRUITINGPhase 2Sponsored by Incyte Corporation
Actively Recruiting
PhasePhase 2
SponsorIncyte Corporation
Started2022-11-08
Est. completion2027-08-29
Eligibility
Age18 Years – 99 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06465433
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
Age: 18 Years – 99 YearsHealthy volunteers accepted
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.
Conditions2
CancerHematologic Malignancies
Interventions1
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Actively Recruiting
PhasePhase 2
SponsorIncyte Corporation
Started2022-11-08
Est. completion2027-08-29
Eligibility
Age18 Years – 99 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06465433