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

NCT06465433 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: MOR208C2162022-500765-27-00
• Study Type: interventional
• Target: 25
• Locations: 5 countries
• Sites: 5

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..

Conditions

Hematologic Malignancies

Outcome Measures

Primary Outcomes (1)

• Number of participants with Treatment-emergent Adverse Events (TEAEs)

  Defined as any Adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 90 days after the last dose of study drug.

  up to approximately 2 years

Study Arms (1)

Tafasitamab Dose

EXPERIMENTAL

Treatment with tafasitamab is as per the treatment dose and schedule they received in the parent protocols.

Drug: Tafasitamab

Interventions

Tafasitamab DRUG

Treatment with tafasitamab is as per the treatment dose and schedule they received in the parent protocols.

Tafasitamab Dose

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (5)

Petz Aladar County Teaching Hospital

Győr, 09023, Hungary

RECRUITING

Hospital S.M. Terni University of Perugia

Terni, 05100, Italy

COMPLETED

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Clinica Universitad de Navarra

Pamplona, 31008, Spain

COMPLETED

Gazi University Hospital Gazi University Faculty of Medicine

Ankara, 06500, Turkey (Türkiye)

RECRUITING

Related Links

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

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

tafasitamab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Incyte Medical Director

  Incyte Corporation

  STUDY DIRECTOR

Central Study Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463; medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423; eumedinfo@incyte.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: November 8, 2022
• Primary Completion (Estimated): August 29, 2027
• Study Completion (Estimated): August 29, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Locations

ES (1); TU (1); KR (1); HU (1); IT (1)