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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-08

Study Completion Date

2027-08-29

Brief Summary

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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..

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Detailed Description

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Conditions

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Hematologic Malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tafasitamab Dose

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

Group Type EXPERIMENTAL

Tafasitamab

Intervention Type DRUG

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

Interventions

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Tafasitamab

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No