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New treatment option for Diffuse Large B-Cell Lymphoma (DLBCL)
Official title A Study to Evaluate the Impact of Mosunetuzumab Consolidation for Older Patients With Diffuse Large B-cell Lymphoma (DLBCL) Who Have Detectable Amounts of ctDNA (Circulating Tumor DNA) at the End of Treatment With Pola-R-mini-CHP
ClinicalTrials.gov ID: NCT06828991
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 diffuse large b-cell lymphoma (dlbcl).
Also referred to as Lunsumio.
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
- Older patients with diffuse large B- cell lymphoma (DLBCL) do not have the same rates of disease control as younger patients and are at risk for toxicity. Identifying which patients might benefit from more therapy at the end of first-line treatment is important.
- 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 70 and older
You may be able to join if
- Patients aged greater than or equal to 70 years of age who are ineligible for full-intensity chemoimmunotherapy at the discretion of the treating...
- ECOG performance status of 0-2.
- Histologically-confirmed DLBCL, NOS, high grade B-cell lymphoma with MYC and BCL2 rearrangements, high grade B-cell lymphoma, NOS, and grade 3b...
- Histologic transformation (HT) will be included on the study. This must be confirmed with a biopsy. Patients with HT may have received prior...
- Composite and discordant lymphomas containing both indolent and large cell features will be included.
You likely can't join if
- Patients who meet any of the following exclusion criteria are not to be enrolled to this study:
- History of, or clinically apparent central nervous system (CNS) lymphoma
- Primary mediastinal B-cell lymphoma
- Patient is receiving peritoneal dialysis or hemodialysis
- Patient has \> Grade 1 peripheral neuropathy.
- EF \<45% or significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or...
See the full eligibility criteria
- Patients aged greater than or equal to 70 years of age who are ineligible for full-intensity chemoimmunotherapy at the discretion of the treating investigator. If between the ages of 70-79, the reason for ineligibility...
- ECOG performance status of 0-2.
- Histologically-confirmed DLBCL, NOS, high grade B-cell lymphoma with MYC and BCL2 rearrangements, high grade B-cell lymphoma, NOS, and grade 3b follicular lymphoma
- Histologic transformation (HT) will be included on the study. This must be confirmed with a biopsy. Patients with HT may have received prior treatment for indolent lymphoma including chemoimmunotherapy but must not have...
- Composite and discordant lymphomas containing both indolent and large cell features will be included.
- Has received no prior therapy for aggressive B-cell lymphoma or HT with the following exceptions: a course of corticosteroids given for lymphoma related symptoms or one cycle of anthracycline containing chemotherapy...
- Ejection fraction of ≥ 45% on echocardiogram or MUGA
- Patient has a platelet count of ≥75,000/µL within the screening period unless inadequate function is due to bone marrow infiltration with aggressive B-cell lymphoma in which case the platelet count should be ≥ 30,000/µL
- Patient has an absolute neutrophil count of ≥1,500/ µL within the screening period unless inadequate function is due to bone marrow infiltration with aggressive B-cell lymphoma in which case the neutrophil count should...
- Patient has a calculated or measured creatinine clearance of \>40 mL/minute within the screening period.
- Total bilirubin must be less than 1.5 times the upper limit of normal (ULN) unless the elevation is known to be due to Gilbert syndrome or hepatic involvement with aggressive B-cell lymphoma in which case it can be ≤...
- Patient has, with treatment in the opinion of the treating investigator, a life expectancy of at least 12 weeks.
- Signed Informed Consent Form
- Ability to comply with the study protocol
- Patients who meet any of the following exclusion criteria are not to be enrolled to this study:
- History of, or clinically apparent central nervous system (CNS) lymphoma
- Primary mediastinal B-cell lymphoma
- Patient is receiving peritoneal dialysis or hemodialysis
- Patient has \> Grade 1 peripheral neuropathy.
- EF \<45% or significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 6...
- Patient has received other investigational drugs within 28 days before enrollment.
- Prior exposure to anthracycline
- Patient has concomitant active malignancy that the treating physician or PI feels may interfere with the ability to measure the primary or secondary outcomes. Patients with stage 1 cancers are eligible after definitive...
- Participants who have a positive HIV test at screening, with the following exception: Individuals with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4...
- Patient has active hepatitis B with a positive surface antigen or viral load. Carriers of hepatitis B virus should be closely monitored for clinical and laboratory signs of active HBV infection and for signs of...
- History of solid organ transplantation, or post-transplant lymphoproliferative disorder.
- Patient has history of allogeneic stem cell transplantation.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study including clinically significant CNS disease, active infections, or autoimmune disease that in the opinion of the...
- Any clinically significant abnormality in screening blood chemistry, hematology, or urinalysis results that, in the judgment of the investigator, would impede adequate evaluation of adverse events and/or response to...
- Treatment with systemic immunosuppressive medications, including, but not limited to, prednisone (\>20 mg), azathioprine, methotrexate, thalidomide, and antitumor necrosis factor agents within 2 weeks prior to Day 1 of...
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, New York, 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, 70 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, New York, 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.