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Trial Title:
Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab
NCT ID:
NCT06465433
Condition:
Hematologic Malignancies
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tafasitamab
Description:
Treatment with tafasitamab is as per the treatment dose and schedule they received in the
parent protocols.
Arm group label:
Tafasitamab Dose
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..
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Petz Aladar County Teaching Hospital
Address:
City:
Gyor
Zip:
09023
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Hospital S.M. Terni University of Perugia
Address:
City:
Terni
Zip:
05100
Country:
Italy
Status:
Completed
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Clinica Universitad de Navarra
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Completed
Facility:
Name:
Gazi University Hospital Gazi University Faculty of Medicine
Address:
City:
Ankara
Zip:
06500
Country:
Turkey
Status:
Recruiting
Start date:
November 8, 2022
Completion date:
August 29, 2027
Lead sponsor:
Agency:
Incyte Corporation
Agency class:
Industry
Source:
Incyte Corporation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06465433
