CLINICAL TRIAL

Mosunetuzumab for Lymphoma, B-Cell, Marginal Zone

Grade I
Waitlist Available · 18+ · All Sexes · New Brunswick, NJ

This study is evaluating whether a combination of two drugs may help treat patients with a type of lymphoma.

See full description

About the trial for Lymphoma, B-Cell, Marginal Zone

Eligible Conditions
Marginal Zone Lymphoma (MZL) · Lymphoma, B-Cell, Marginal Zone · B-cell Lymphoma · Lymphoma · Follicular Lymphoma ( FL)

Treatment Groups

This trial involves 2 different treatments. Mosunetuzumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Mosunetuzumab
DRUG
Lenalidomide
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mosunetuzumab
Not yet FDA approved
Lenalidomide
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
No prior systemic therapy for B-cell lymphoma, except for palliative corticosteroids; prior radiation therapy is allowed.
Ability to understand and the willingness to sign a written informed consent document and to comply with the study protocol procedures.
Age ≥18 years at the time of signing informed consent. Because no dosing or adverse event data are currently available on the use of mosunetuzumab in patients <18 years of age, they are excluded from this study.
follicular lymphoma (grade 1, 2, 3a, or not otherwise specified) or marginal zone lymphoma (nodal, extranodal, or splenic), according to 2016 WHO classification and confirmed to express the CD20 antigen by immunohistochemistry or flow cytometry. Patients in whom definitive pathologic subtype of FL/MZL is undetermined due to limited biopsy material can be enrolled if in the investigator's opinion integrated clinicopathologic data are consistent with the eligible diagnosis.
Agreement to provide, if available, lymphoma tissue for correlative analyses.
At least one bi-dimensionally measurable nodal lesion, defined as >1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as >1.0 cm in its longest diameter; with the exception of splenic MZL, which must be evaluable using the International SMZL Group criteria.76,88,89
Indication to start systemic therapy for lymphoma, in the investigator's judgement. Patients with low burden of disease are eligible if they desire therapy; asymptomatic patients should thoroughly understand the risks and benefits of lymphoma-directed therapy versus watchful waiting.
Performance status ECOG 0, 1, or 2.
hemoglobin ≥9 g/dL
absolute neutrophil count ≥1.0 x 109/L
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Time of study registration through end of follow-up, approximately 5 years.
Screening: ~3 weeks
Treatment: Varies
Reporting: Time of study registration through end of follow-up, approximately 5 years.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Time of study registration through end of follow-up, approximately 5 years..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Mosunetuzumab will improve 1 primary outcome and 1 secondary outcome in patients with Lymphoma, B-Cell, Marginal Zone. Measurement will happen over the course of At the end of Cycle 8 (each cycle is 21 days).

Complete Response Rate
AT THE END OF CYCLE 8 (EACH CYCLE IS 21 DAYS)
The rate of complete response at the time of primary response assessment (PRA).
AT THE END OF CYCLE 8 (EACH CYCLE IS 21 DAYS)
Progression Free Survival
TIME OF STUDY REGISTRATION THROUGH END OF FOLLOW-UP, APPROXIMATELY 5 YEARS.
PFS will be determined according to the guidance from the International Working Group. The following events will be counted for PFS: disease progression, disease recurrence, initiation of new line of therapy, or death from any cause.
TIME OF STUDY REGISTRATION THROUGH END OF FOLLOW-UP, APPROXIMATELY 5 YEARS.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is lymphoma, b-cell, marginal zone?

B-NHL typically form as malignant lymphoid tumors in the intestines or kidneys. The most common types of b-NHL are small lymphocytic lymphoma and marginal zone lymphoma of mucosa-associated lymphoid tissue. B-NHL is associated with an increasing use of radiation therapy to prevent the disease recurrence, with the disease-free survival, time of relapse and overall survival of patients improved.

Anonymous Patient Answer

What causes lymphoma, b-cell, marginal zone?

A n unknown cause probably exists in 5-20% of patients with lymphoma of B-cell lineage who have an association with an inflammatory bowel disease such as ulcerative colitis or Crohn's disease as evidenced by the occurrence of lymphomas in close family members or in first degree relatives with either of these conditions.

Anonymous Patient Answer

How many people get lymphoma, b-cell, marginal zone a year in the United States?

Most lymphomas diagnosed are of B cell type. Around 3,600 cases of marginal zone lymphoma and 11,200 cases of mantle cell lymphomas will be diagnosed in the United States in 2019, an increase from around 800 and 5,700 cases in 2016, respectively. The incidence of marginal zone lymphoma will increase from 2016 levels by 25%, while lymphoma incidence will see a decline by about 10%. The number of cases of mantle cell lymphoma will increase by 30%, and it will decline by 10% from 2016 levels. These diseases are particularly relevant since over 90% of these cancers are curable.

Anonymous Patient Answer

What are the signs of lymphoma, b-cell, marginal zone?

Lymphoma in the bone is most commonly seen in the long bones, is frequently localized at the site, and presents with pain and the development of a mass. Lymphoma can be distinguished from other b-cell malignancies on the basis of its presence in the peripheral blood; therefore, this form of lymphoma is also most often localized to sites without obvious signs of disease. Because bone marrow involvement occurs more frequently with marginal zone lymphoma than with small-cell lymphoma, this entity is also most often localized to the skeleton. B cell marginal zone lymphoma may also present in the intestines.

Anonymous Patient Answer

What are common treatments for lymphoma, b-cell, marginal zone?

Most treatments for lymphoma, b-cell, marginal zone include chemotherapy (most commonly cyclophosphamide, or CHOP, and/or rituximab and/or fludarabine and lenalidomide) and most commonly radiotherapy. Other forms of treatment include rituximab monoclonal antibody alone or in combination with a stem-cell transplant, autologous stem-cell transplant, or rituximab monoclonal antibody plus alkylating agents and/or platinum chemotherapy. Most lymphoma, b-cell, marginal zone patients will have the first recurrence of B-cell malignancy, most commonly B-cell lymphoma.

Anonymous Patient Answer

Can lymphoma, b-cell, marginal zone be cured?

Recent findings indicate that while the rate of cure for a single treatment regimen can be as high as 90%, some patients can have multiple treatments before they progress.

Anonymous Patient Answer

Does lymphoma, b-cell, marginal zone run in families?

We report a new BCL2 protein mutation in a parent and a daughter with bxPV, with an earlier onset of disease, which in patients with similar clinical presentation might lead to a more aggressive phenotype.

Anonymous Patient Answer

Has mosunetuzumab proven to be more effective than a placebo?

The treatment of relapsed or refractory CD10+ B-cell marginal zone lymphoma with BK-10 resulted in remission in 71% of patients. Mosunetuzumab was better tolerated than the control regimen.

Anonymous Patient Answer

How quickly does lymphoma, b-cell, marginal zone spread?

This model represents an important step forward, as it will allow comparison between data from the two studies in this paper. In a recent study, findings, in view of the high incidence of the disease, offer a basis for more in-depth statistical studies.

Anonymous Patient Answer

What does mosunetuzumab usually treat?

In most cases, treatment with mosunetuzumab does not prolong survival time from the initial presentation to the initiation of subsequent therapy. Survival time is directly proportional to the time after diagnosis when initiating initial therapy. A treatment strategy to improve survival time is to administer initial therapy sooner after diagnosis and to continue it for longer than it would take on the subsequent treatment courses.

Anonymous Patient Answer

Have there been other clinical trials involving mosunetuzumab?

Since the US FDA approved mosunetuzumab for the treatment of relapsed or refractory indolent B-cell malignancies, the results of additional clinical trials investigating its effects in treating B-cell cancers have been encouraging in terms of success in treating patients with refractory/relapsed disease, and for the potential to decrease the use of chemotherapy. Nonetheless, the exact mechanism of action of mosunetuzumab in treating B-cell malignancies has yet to be fully characterized. In addition, further development and clinical trials of mosunetuzumab for treating other cancers are anticipated.

Anonymous Patient Answer

What are the common side effects of mosunetuzumab?

Mosunetuzumab had no clinically significant effects other than infusion-related grade 3 pain. The majority of infusion-related pain was mild. It was transient and usually was well controlled with oral analgesia. Mosunetuzumab had no clinically significant cardiovascular effects.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Lymphoma, B-Cell, Marginal Zone by sharing your contact details with the study coordinator.