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New treatment option for CNS Lymphoma
Official title Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma
ClinicalTrials.gov ID: NCT05351593
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 cns lymphoma.
Also referred to as MOR208.
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
- This is a single arm open-label multicenter phase I/II investigation of combination lenalidomide/Tafasitamab in patients with relapsed central nervous system (CNS) lymphoma. This is the first study to examine a naked anti-CD19 monoclonal antibody in relapsed CNS lymphoma patients as well as the combination of anti-CD19 antibody plus an Immunomodulatory imide drugs (IMiDs) in CNS lymphomas.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 year
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have relapsed primary or secondary CNS lymphoma, diffuse large B-cell lymphoma (DLBCL) type, based on radiographic, ophthalmologic...
- Concomitant systemic lymphoma as well as transformation from follicular lymphoma and/or Chronic lymphocytic leukemia (CLL) to an aggressive B-cell...
- Participants are eligible with disease in each CNS compartment: brain, leptomeninges/CSF and intraocular compartment.
- Age \>= 18 years.
- Anticipated survival \> 2 months, as determined by the investigator.
You likely can't join if
- Has received systemic anti-cancer therapies within 2 weeks of first dose, radiation within 1 week, antibody therapy within 4 weeks.
- Has not recovered from adverse events due to prior anti-cancer therapy to ≤ grade 1 or baseline (other than alopecia).
- Is currently receiving any other investigational agents.
- Has participated in a study of an investigational product and received study treatment or used an investigational device within four weeks of the...
- Has a history of HIV infection.
- Has CNS post-transplant lymphoproliferative disease (PTLD).
See the full eligibility criteria
- Participants must have relapsed primary or secondary CNS lymphoma, diffuse large B-cell lymphoma (DLBCL) type, based on radiographic, ophthalmologic, or CSF criteria (evidence of malignant cells based on CSF studies...
- Concomitant systemic lymphoma as well as transformation from follicular lymphoma and/or Chronic lymphocytic leukemia (CLL) to an aggressive B-cell histology is allowed.
- Participants are eligible with disease in each CNS compartment: brain, leptomeninges/CSF and intraocular compartment.
- Age \>= 18 years.
- Anticipated survival \> 2 months, as determined by the investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status \ = 70%)
- Demonstrates adequate organ function as defined below:
- Absolute neutrophil count (ANC) ≥ 1.5 X 10\^9/ L (1,500/ microliter (mcL), growth factors permitted).
- Platelets \>= 50 X 10\^9 / L (50,000/ mcL, platelet transfusion independent).
- Total bilirubin \<= 1.5 x institutional upper limit of normal,unless elevated due to Gilbert's syndrome.
- Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) \<=3 X institutional upper limit of normal.
- Alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) \ = 60 mL/min/1.73 m\^2, calculated using the Cockcroft-Gault equation. CrCl \> 60 mL/min/1.73 m2 is requisite for eligibility for the phase I...
- Ability to understand and the willingness to sign a written informed consent document.
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. If a HBV test comes up positive due to Intravenous...
- Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV...
- Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible...
- The effects of the study drugs on the developing human fetus are unknown. For this reason, and because the teratogenic effect of lenalidomide in humans cannot be ruled out, females of child-bearing potential (FCBP) and...
- Prior Therapies
- Participants with CNS lymphoma involving the brain parenchyma must have received at least one prior systemic therapy.
- Participants with secondary CNS lymphoma must have received prior CNS-directed treatment.
- There is no limit in terms of prior lines of therapy received. Patients may have progressed after prior treatment with IMiD's (including lenalidomide, pomalidomide and CC122), patients may have had prior rituximab or...
- Recipients of prior hematopoietic stem cell transplant are eligible as long as the following criteria are met:
- Absence of graft versus host disease.
- Discontinuation of systemic immunosuppressant therapy.
- Has received systemic anti-cancer therapies within 2 weeks of first dose, radiation within 1 week, antibody therapy within 4 weeks.
- Has not recovered from adverse events due to prior anti-cancer therapy to ≤ grade 1 or baseline (other than alopecia).
- Is currently receiving any other investigational agents.
- Has participated in a study of an investigational product and received study treatment or used an investigational device within four weeks of the first dose of treatment.
- Has a history of HIV infection.
- Has CNS post-transplant lymphoproliferative disease (PTLD).
- Has known hypersensitivity to lenalidomide or Tafasitamab.
- Pregnant women and women of child-bearing potential who will not using an effective method of birth control (detailed in Appendix 3) are excluded from this study because the study drugs have potential for teratogenic or...
- Prior receipt of anti-CD19 based therapy including anti-CD19, Chimeric antigen receptor T cells (CAR-T) therapy is an exclusion criteria.
- Has any significant medical condition or comorbidity that could compromise patient safety (e.g., uncontrolled serious infection).
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
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 study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.