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

Hematologic Malignancies Clinical Trial

Official title:

An Open-Label, Multicenter, Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06465433
• Other study ID #: MOR208C216
• Secondary ID: 2022-500765-27-0
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 18, 2024
• Est. completion date: August 29, 2027

Study information

• Verified date: June 2024
• Source: Incyte Corporation
• Contact: Incyte Corporation Call Center (US)
• Phone: 1.855.463.3463
• Email: medinfo[@]incyte.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: August 29, 2027
• Est. primary completion date: August 29, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Malignancies
• Hematologic Neoplasms
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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