Hematologic MalignanciesPhase 2NCT06465433
Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab
A Phase 2 study testing Tafasitamab in people with Hematologic Malignancies, run by Incyte Corporation at 5 sites in 5 countries.
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.. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- Tafasitamab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 8 Nov 2022to 29 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 5 countries
Hungary1 site, 1 recruiting
- Recruiting
Petz Aladar County Teaching Hospital
Győr, 09023
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University Hospital Gazi University Faculty of Medicine
Ankara, 06500
About this study
Official title: An Open-Label, Multicenter, Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab
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
- Being tested
- Tafasitamab
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TafasitamabDrug
Treatment with tafasitamab is as per the treatment dose and schedule they received in the parent protocols.
| Study group | Role | What they receive |
|---|---|---|
| Tafasitamab Dose | Experimental | Treatment with tafasitamab is as per the treatment dose and schedule they received in the parent protocols. Receives: Drug: Tafasitamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start8 Nov 2022
- Primary completion29 Aug 2027 (estimated)
- Study completion29 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Director, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465433
- Sponsor's protocol ID
- MOR208C216
- Other IDs
- 2022-500765-27-00
- Status last verified
- Dec 2025
- First submitted
- 13 Jun 2024
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab
- ClinicalTrials.gov ID
- NCT06465433
- Acronym / sponsor ID
- MOR208C216
- Conditions
- Hematologic Malignancies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 29 Aug 2027 (estimated)
- Study completion
- 29 Aug 2027 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tafasitamab Dose | Experimental | Drug: TafasitamabTreatment with tafasitamab is as per the treatment dose and schedule they received in the parent protocols. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TafasitamabTreatment with tafasitamab is as per the treatment dose and schedule they received in the parent protocols. | Drug | Tafasitamab Dose |
Primary outcome
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: up to approximately 2 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With TafasitamabLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Incyte Medical Director study director
Incyte Corporation
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tafasitamab in people with Hematologic Malignancies, run by Incyte Corporation at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Hungary, Italy, South Korea, Spain, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Incyte Corporation Call Center (US) (1.855.463.3463, medinfo@incyte.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Treatment-emergent Adverse Events (TEAEs) (time frame: up to approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.