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New treatment option for Non-Hodgkin Lymphoma
Official title Methotrexate, Tafasitamab, Lenalidomide and Rituximab in Patients With PCNSL
ClinicalTrials.gov ID: NCT05583071
What this study is testing
What is Tafasitamab?
Tafasitamab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-hodgkin lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Pilot-trial of Methotrexate, Tafasitamab (Minjuvi®), Lenalidomide (Revlimid®) and Rituximab in patients ineligible for HCT-ASCT with Primary Central Nervous System Lymphoma (PCNSL)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Age 18-69 years with ECOG PS ≥2 or age ≥70 years, and ineligible for HCT-ASCT as per investigators discretion
- Previously untreated, histologically (or cytologically) confirmed diagnosis of primary B-cell lymphoma of the central nervous system (PCNSL) by local...
- At least one measurable lesion
- Adequate organ function:
- Adequate kidney function, defined as:
You likely can't join if
- Prior treatment for PCNSL with the exception of a pre-phase treatment comprising steroid treatment and / or single application of rituximab 375 mg/m²...
- Systemic lymphoma manifestation outside the CNS
- Diagnosis of previous Non-Hodgkin lymphoma at any time
- Primary vitreoretinal or leptomeningeal lymphoma without manifestation in the brain parenchyma or spinal cord
- HIV infection of any stage as determined by presence of anti-HIV antibodies (confirmatory test) and / or presence of RNA confirmed by PCR
- Previous or concurrent malignancies with the following exceptions:
See the full eligibility criteria
- Age 18-69 years with ECOG PS ≥2 or age ≥70 years, and ineligible for HCT-ASCT as per investigators discretion
- Previously untreated, histologically (or cytologically) confirmed diagnosis of primary B-cell lymphoma of the central nervous system (PCNSL) by local pathologist. Diagnostic sample obtained by stereotactic or surgical...
- At least one measurable lesion
- Adequate organ function:
- Adequate kidney function, defined as:
- Serum creatinine estimated glomerular filtration rate (MDRD) ≥ 50 ml/min
- Adequate hepatic function, defined as:
- ALAT and ASAT ≤ 3 ULN
- Bilirubin ≤ 2.0 mg/dl (except for Meulengracht disease)
- Adequate bone marrow function, defined as:
- White blood cell (WBC) count ≥ 3000/µL or absolute neutrophil count (ANC) ≥ 1000/µL
- Platelets ≥ 50.000/µL
- Hemoglobin \> 8.0 g/dl
- Adequate cardiac function, defined as:
- Cardiac ejection fraction ≥ 40%
- Adequate pulmonary function as per investigators discretion
- Written, signed, and dated informed consent for the trial provided by the participant
- Female persons are eligible to participate if they are post-menopausal or females of no childbearing potential or if they agree to use a method of contraception considered safe described in Section 12.1.2.1.
- Male persons with female partners of childbearing potential are eligible to participate if they agree to contraceptive methods as described in Section 12.1.2.2.
- Prior treatment for PCNSL with the exception of a pre-phase treatment comprising steroid treatment and / or single application of rituximab 375 mg/m² and methotrexate 3.5 g/m²
- Systemic lymphoma manifestation outside the CNS
- Diagnosis of previous Non-Hodgkin lymphoma at any time
- Primary vitreoretinal or leptomeningeal lymphoma without manifestation in the brain parenchyma or spinal cord
- HIV infection of any stage as determined by presence of anti-HIV antibodies (confirmatory test) and / or presence of RNA confirmed by PCR
- Previous or concurrent malignancies with the following exceptions:
- Surgically cured carcinoma in-situ
- Other kinds of cancer without evidence of disease for at least 5 years
- Hypersensitivity to study treatment or any component of the formulation
- Stomatitis or gastrointestinal ulcerations preventing the use of methotrexate
- Hepatitis B, hepatitis C or hepatitis E infection as determined by PCR
- Severe active infection
- Congenital or acquired immunodeficiency including previous organ transplantation
- Pregnant or nursing (lactating) women.
- Lack of accountability and inability to appreciate the nature, meaning and consequences of the trial and to formulate their own wishes correspondingly
- Non-compliance, for reasons including, but not limited to the following:
- Increased alcohol consumption, drug dependency or substance abuse that would interfere with cooperation with requirements of the trial
- Refusal of blood products during treatment
- Any similar circumstances that appear to make protocol treatment or long-term follow-up impossible
- Relationship of dependence or employer-employee relationship to the sponsor or the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Stuttgart, Baden-Wurttemberg, Germany
- Freiburg im Breisgau, Baden-Würtemberg, Germany
- Cologne, Germany, Germany
- Hamburg, Hamurg, Germany
- Essen, Nordrhein Westphalen, Germany
- Berlin, State of Berlin, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stuttgart, Baden-Wurttemberg, Germany; Freiburg im Breisgau, Baden-Würtemberg, Germany; Cologne, Germany, Germany; Hamburg, Hamurg, Germany; Essen, Nordrhein Westphalen, Germany; Berlin, State of Berlin, Germany. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.