Clinical trial NCT06465433: Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab
Official title: An Open-Label, Multicenter, Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hematologic Malignancies
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2024-06-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Number of participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: up to approximately 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gyor
country: Hungary
facility: Petz Aladar County Teaching Hospital
city: Terni
country: Italy
facility: Hospital S.M. Terni University of Perugia
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Pamplona
country: Spain
facility: Clinica Universitad de Navarra
city: Ankara
country: Turkey
facility: Gazi University Hospital Gazi University Faculty of Medicine
Study officials:
affiliation: Incyte Corporation
name: Incyte Medical Director
role: STUDY_DIRECTOR
References: