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Mosunetuzumab for Follicular Lymphoma

Rutgers Cancer Institute of New Jersey, New Brunswick, NJ
Follicular Lymphoma+2 More ConditionsMosunetuzumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new treatment for lymphoma that involves using mosunetuzumab alone for four cycles, followed by an assessment of response. If the patient responds well, they will continue treatment with mosunetuzumab. If the patient does not respond well, they will receive mosunetuzumab with lenalidomide augmentation during the next four cycles.

Eligible Conditions
  • Follicular Lymphoma
  • Marginal Zone Lymphoma
  • Non-Hodgkin's Lymphoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
Mosunetuzumab
1
Lenalidomide
1
Lenalidomide

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Time of study registration through end of follow-up, approximately 5 years.

Day 21
Complete Response Rate
Year 5
Progression Free Survival

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Mosunetuzumab
1
Lenalidomide
1
Lenalidomide

Side Effects for

Phase 1 and Phase II: Event Free Survival and Overall Survival
44%Neutrophil count decreased
8%Infusion related reaction
8%Weakness
6%Fever
6%Fatigue
6%Platelet count decreased
6%Investigations - Other, specify
3%Infections and infestations - Other, specify
3%Hypokalemia
3%Left ventricular systolic dysfunction
3%Atrial fibrillation
3%Respiratory Failure
3%Myocardial infarction
3%sepsis
3%Chest pain
3%Pleural effusion
3%Atrial flutter
3%Cardiac arrest
3%Renal and urinary disorders - Other, specify
3%Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
3%Respiatory, thoracic and mediastinal disorders - Other, specify
3%confusion
3%Respiratory, thoracic and medicastinal disorders - Other, specify
3%Abdominal Pain
3%Nausea
3%Injury, poisoning and procedural complications - Other, specify
3%Acidosis
3%Cough
3%Encephalopathy
3%Aortic valve disease
This histogram enumerates side effects from a completed 2018 Phase 1 & 2 trial (NCT01060384) in the Phase 1 and Phase II: Event Free Survival and Overall Survival ARM group. Side effects include: Neutrophil count decreased with 44%, Infusion related reaction with 8%, Weakness with 8%, Fever with 6%, Fatigue with 6%.

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Planned Therapy
1 of 1

Experimental Treatment

52 Total Participants · 1 Treatment Group

Primary Treatment: Mosunetuzumab · No Placebo Group · Phase 2

Planned TherapyExperimental Group · 2 Interventions: Mosunetuzumab, Lenalidomide · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mosunetuzumab
Not yet FDA approved
Lenalidomide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: time of study registration through end of follow-up, approximately 5 years.

Who is running the clinical trial?

Adam OlszewskiLead Sponsor
2 Previous Clinical Trials
31 Total Patients Enrolled
Brown UniversityLead Sponsor
432 Previous Clinical Trials
524,128 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,513 Previous Clinical Trials
568,219 Total Patients Enrolled
Adam J Olszewski, MDPrincipal InvestigatorBrown University
2 Previous Clinical Trials
11 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The tumor is causing problems with the normal function of an organ or causing symptoms in the area.
References

Frequently Asked Questions

Are there currently any open enrolment opportunities for this research initiative?

"As per the information posted on clinicaltrials.gov, this trial is actively seeking patient participants. It was initially published on July 14th 2022 and has been recently amended as of November 17th 2022." - Anonymous Online Contributor

Unverified Answer

How many participants are actively engaged in this clinical experiment?

"Genentech, Inc. is seeking a total of 52 participants that meet the criteria for this trial and will be operating it out of two sites: Rutgers Cancer Institute in New Jersey and Yale Cancer Center in Connecticut." - Anonymous Online Contributor

Unverified Answer

Could you enlighten me on any other experiments involving Mosunetuzumab?

"Mosunetuzumab was first studied at Saint Joseph Regional Medical Center-Mishawaka in 2004; since then, 347 clinical trials have been concluded. Currently 277 are actively recruiting participants, many based out of New Brunswick, New Jersey." - Anonymous Online Contributor

Unverified Answer

To what extent might Mosunetuzumab be hazardous to patients?

"Mosunetuzumab's safety is rated at a 2, as the Phase 2 trial indicates this drug has some evidence of being safe but none demonstrating its efficacy." - Anonymous Online Contributor

Unverified Answer

What medical applications has Mosunetuzumab been utilized for?

"Mosunetuzumab is a frequently employed treatment for multiple myeloma and other refractory lymphomas, chronic lymphocytic leukemia, and conditions requiring two prior systemic chemotherapy regimens." - Anonymous Online Contributor

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

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