Clinical trial · Interventional
Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab
An Open-Label, Multicenter, Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab
NCT06465433CI-TRIAL-00098712recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tafasitamab | Drug | Tafasitamab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tafasitamab Dose
- description
- Treatment with tafasitamab is as per the treatment dose and schedule they received in the parent protocols.
- interventionNames
- Drug: Tafasitamab
Primary outcomes (1)
- measure
- Number of participants with Treatment-emergent Adverse Events (TEAEs)
- timeFrame
- up to approximately 2 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.