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New treatment option for Hodgkin Lymphoma
Official title A Phase II Trial of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide in Patients With Relapsed B-cell NHL
ClinicalTrials.gov ID: NCT05615636
What this study is testing
What is Mosunetuzumab?
Mosunetuzumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hodgkin lymphoma.
Also referred to as RO7030816.
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
- To learn if giving mosunetuzumab in combination with polatuzumab vedotin, tafasitamab, and lenalidomide can help to control relapsed/refractory FL and DLBCL.
- 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 and older
You may be able to join if
- Patients in safety run in must meet the following criteria for study entry:
- A diagnosis of relapsed CD20+ Follicular Lymphoma grade 1-3a
- A diagnosis of relapsed CD20+ diffuse large B-cell lymphoma Patients in dose expansion must meet the following criteria for study entry:
- A diagnosis of relapsed CD20+ diffuse large B-cell lymphoma Patients in each component (safety run in and dose expansion) must meet the following...
- Evidence of progression or lack of response following at least 1 prior treatment
You likely can't join if
- Known hypersensitivity to any study drug
- Prior treatment with polatuzumab vedotin
- Prior treatment with mosunetuzumab or other CD20-directed bispecific antibodies
- Prior treatment with tafasitamab and/or lenalidomide
- Autologous SCT within 100 days prior to first study treatment administration
- Prior treatment with CAR-T therapy within 30 days before first study treatment administration
See the full eligibility criteria
Who can join
- Patients in safety run in must meet the following criteria for study entry:
- A diagnosis of relapsed CD20+ Follicular Lymphoma grade 1-3a
- A diagnosis of relapsed CD20+ diffuse large B-cell lymphoma Patients in dose expansion must meet the following criteria for study entry:
- A diagnosis of relapsed CD20+ diffuse large B-cell lymphoma Patients in each component (safety run in and dose expansion) must meet the following criteria for study entry:
- Evidence of progression or lack of response following at least 1 prior treatment
- Able and willing to provide written informed consent and to comply with the study protocol
- Age ≥ 18 years as these drugs have not yet established safety and how well it works in pediatric patients
- At least 1 site of measurable disease greater than 1.5cm
- Adequate hematologic function (unless abnormalities are related to NHL), defined as follows:
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count ≥ 1.0 x 109/L
- Platelet count ≥ 75 x 109/L
- Serum bilirubin \ 80% unconjugated bilirubin who must have a serum bilirubin of \<4x ULN; AST (SGOT) and ALT (SGPT) ≤ 3x ULN or \< 5x ULN if hepatic metastases are present
- Renal function assessed by calculated creatinine clearance: . Calculated creatinine clearance ≥30ml/min by Cockcroft-Gault formula. See section below, "Dosing Regimen", regarding lenalidomide dose adjustment for...
- Patients must be willing to receive transfusions of blood products.
- For men who are not surgically sterile, agreement to use a barrier method of contraception for ≥ 3 months after the last treatment dose. In addition, male patients must agree to request that their partners use an...
- For women of reproductive potential who are not surgically sterile, agreement to use two adequate methods of contraception, such as oral contraceptives, intrauterine device, or barrier method of contraception in...
- Females of childbearing potential (FCBP, defined as a female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2)has not been naturally...
- All study participants must be registered into the mandatory Revlimid REMS® program and be willing and able to comply with the requirements of Revlimid REMS® program.
- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
What rules you out
- Known hypersensitivity to any study drug
- Prior treatment with polatuzumab vedotin
- Prior treatment with mosunetuzumab or other CD20-directed bispecific antibodies
- Prior treatment with tafasitamab and/or lenalidomide
- Autologous SCT within 100 days prior to first study treatment administration
- Prior treatment with CAR-T therapy within 30 days before first study treatment administration
- Current eligibility for autologous SCT in patients with R/R DLBCL
- Prior allogeneic SCT
- Prior solid organ transplantation
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
- Regular treatment with corticosteroids during the 2 weeks prior to the start of Cycle 1, unless administered for indications other than NHL at a dose equivalent to \< 20 mg/day prednisone. Treatment with systemic...
- Prior systemic treatment with chemotherapy, immunotherapy, targeted and biologic therapy 4 weeks prior to C1D1.
- Prior treatment with radiotherapy within 2 weeks prior to C1D1. If patients have received radiotherapy within 4 weeks prior to the initiation of study treatment, patients must have at least one measurable lesion outside...
- History of prior malignancy within the last 2 years, except for curatively treated basal or squamous cell carcinoma of the skin and low- grade in situ carcinoma of the cervix
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study, or which could affect compliance...
- Known or suspected history of hemophagocytic lymphohistiocytosis
- History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis...
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization...
- Patients with suspected active or latent tuberculosis (latent tuberculosis needs to be confirmed by positive Interferon-gamma release assay)
- Known or suspected chronic active Epstein-Barr virus (EBV) infection
- Known HIV infection. Hepatitis B or C serologic status: people who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antigen (HBsAg) negative will need to have a negative DNA polymerase...
- Vaccination with live vaccines within 28 days prior to start of treatment
- No peripheral neuropathy ≥ grade 2 or = grade 2 with pain
- Pregnant or lactating females.
- Women of childbearing potential must have a negative serum (-human chorionic gonadotropin [-hCG]) at screening and must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
- All patients with known central nervous system involvement with lymphoma.
- Contraindication to any of the required concomitant drugs or supportive treatments or intolerance to hydration due to preexisting pulmonary or cardiac impairment including pleural effusion requiring thoracentesis or...
- Patients with active pulmonary embolism or deep vein thrombosis (diagnosed within 30 days of study enrollment).
- Major surgery within 4 weeks of study entry, or wound that is not healed from prior surgery or trauma.
- History of stroke or intracranial hemorrhage within 6 months prior to study entry.
- Active bleeding or history of bleeding diathesis (eg, hemophilia or von Willebrand disease).
- Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura).
- Prothrombin time (PT)/INR or aPTT (in the absence of lupus anticoagulant) \>2x ULN.
- Concurrent participation in another therapeutic clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, 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.