Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab

Last updated: July 1, 2025
Sponsor: Incyte Corporation
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasms

Hematologic Neoplasms

Treatment

Tafasitamab

Clinical Study ID

NCT06465433
MOR208C216
2022-500765-27-00
  • Ages 18-99
  • All Genders

Study 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

Inclusion Criteria:

  • Capable of giving signed informed consent which includes compliance with therequirements and restrictions listed in the informed consent form (ICF) and in thisprotocol.

  • Having been enrolled and is still receiving treatment with tafasitamab at the end ofa parent tafasitamab clinical study.

  • Is tolerating tafasitamab treatment at the dose specified in the parent protocol asassessed by the Investigator.

  • Is in complete/partial response or stable disease and is receiving clinical benefitfrom treatment with tafasitamab in the parent study, as assessed by theInvestigator.

  • Has demonstrated compliance, as assessed by the Investigator, with the parentprotocol requirements.

  • Willingness and ability to comply with scheduled visits, treatment plans, and anyother study procedures indicated in this protocol.

Exclusion

Exclusion Criteria:

  • Patient who is legally institutionalized, or under judicial protection.

  • Has met one or more criteria for permanent tafasitamab treatment discontinuation asstipulated 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 orcompliance 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 tofollow the contraceptive guidance during the treatment period and for at least 3months after the last dose of study treatment, and does not refrain from donatingoocytes during this period.

  • A male patient who does not agree to use contraception as detailed in thecontraceptive guidance during the treatment period and for at least 3 months afterthe last dose of study treatment (if they have a heterosexual partner who is a womanof childbearing potential) and who does not refrain from donating sperm during thisperiod.

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: Tafasitamab
Phase: 2
Study Start date:
November 08, 2022
Estimated Completion Date:
August 29, 2027

Connect with a study center

  • Petz Aladar County Teaching Hospital

    Gyor, 09023
    Hungary

    Active - Recruiting

  • Hospital S.M. Terni University of Perugia

    Terni, 05100
    Italy

    Completed

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Clinica Universitad de Navarra

    Pamplona, 31008
    Spain

    Completed

  • Gazi University Hospital Gazi University Faculty of Medicine

    Ankara, 06500
    Turkey

    Active - Recruiting

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