Obinutuzumab for Lymphoma, Follicular

Phase-Based Estimates
3
Effectiveness
3
Safety
Kings College Hospital NHS Foundation Trust, London, United Kingdom
Lymphoma, Follicular+2 More
Obinutuzumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Lymphoma, Follicular

Study Summary

This study is evaluating whether obinutuzumab can be given as a short duration infusion.

See full description

Eligible Conditions

  • Lymphoma, Follicular
  • Lymphoma
  • Advanced Follicular Lymphoma

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Obinutuzumab will improve 1 primary outcome and 10 secondary outcomes in patients with Lymphoma, Follicular. Measurement will happen over the course of From infusion to onset of IRR during Cycle 2 (1 cycle: 21 or 28 days depending on the chemotherapy selected).

Year 5
Duration (In Minutes) of Obinutuzumab Administration by Cycle
Duration of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle
Type of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle
Month 30
Complete Response (CR) Rate at 30 Months (CR30), as Assessed by the Investigator and According to the Guidelines Used at the Site
Year 5
Percentage of Participants With Adverse Events (AEs)
Month 6
Objective Response Rate (ORR) at the End of Induction (EOI) Therapy
Year 4
Overall Survival (OS) at the End of the Study
Progression-Free Survival (PFS) Rate at the End of the Study
Day 28
Time to IRR From Infusion to Onset of the IRR During Cycle 2
Year 5
Percentage of IRRs Regardless of Grade by Cycle
Day 28
Percentage of Grade >=3 Infusion-Related Reactions (IRRs) During Cycle 2 in Patients Who Had Previously Received Obinutuzumab at the Standard Infusion Rate During Cycle 1 Without Experiencing a Grade 3 or 4 IRR

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Control
Obinutuzumab+Chemotherapy

This trial requires 114 total participants across 2 different treatment groups

This trial involves 2 different treatments. Obinutuzumab 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 4 and have been shown to be safe and effective in humans.

Obinutuzumab+ChemotherapyParticipants received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone [CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone [CVP - 21-day cycle]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator is free to choose the chemotherapy for each patient. Obinutuzumab and chemotherapy is administered during induction phase and obinutuzumab monotherapy is administered during maintenance phase.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
FDA approved
Cyclophosphamide
FDA approved
Bendamustine
FDA approved
Vincristine
FDA approved
Obinutuzumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to clinical cut off date (up to approximately 1.5 years)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline up to clinical cut off date (up to approximately 1.5 years) for reporting.

Closest Location

American Oncology Partners of Maryland, PA - Bethesda, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
≥ 7 cm in the greatest diameter b.) Local symptoms or compromise of normal organ function due to progressive nodal disease or extranodal tumor mass c.) Presence of B symptoms (fever [> 38ºC], drenching night sweats, or unintentional weight loss of > 10% of normal body weight over a period of 6 months or less) d.) Presence of symptomatic extranodal disease (e.g., pleural effusions, peritoneal ascites) e.) Cytopenias due to underlying lymphoma (i.e., absolute neutrophil count < 1.0 × 109/L, hemoglobin < 10 g/dL, and/or platelet count < 100 × 109/L) f.) Involvement of ≥ 3 nodal sites, each with a diameter of ≥ 3 cm g.) Symptomatic splenic enlargement
Life expectancy of ≥ 12 months
Adequate hematologic function (unless abnormalities are related to FL)
Histologically documented CD-20-positive FL, as determined by the local laboratory
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Patients with previously untreated Stage III or IV FL or Stage II bulky disease scheduled to receive obinutuzumab plus chemotherapy due to at least one of the following criteria: a.) Bulky disease, defined as a nodal or extranodal (except spleen) mass
For women who are not postmenopausal (≥ 12 consecutive months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 18 months after the last dose of obinutuzumab, for at least 3 months after the last dose of bendamustine or according to institutional guidelines for CHOP or CVP chemotherapy, whichever is longer
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm

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 are the signs of lymphoma, follicular?

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Lymphoma, follicular symptoms of a cough or a decreased rate of breathing can suggest the diagnosis of lymphoma, follicular. Furthermore, because of the variability in presentation of lymphoma, a history of exposure to infectious, occupational or environmental agents is very useful in aiding diagnosis.\n

Unverified Answer

What causes lymphoma, follicular?

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In the majority of cases, lymphoma is caused by the proliferation of a cell in lymphatics. Most cases of lymphoma may be diagnosed due to the development of new symptoms, rather than the presence of a tumor. Risk factors that enhance the incidence or advancement of lymphoma include increased age, a history of viral infections, immunodeficiency states, and family history of cancer. Lymphoma can be caused from a viral infection such as a hepatitis virus or a parvovirus. The development of lymphoma may be related to hepatitis B virus or hepatitis C virus infections, immunodeficiency states, and genetic factors.

Unverified Answer

What are common treatments for lymphoma, follicular?

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Treatments include radiation therapy, chemotherapy, and/or watchful waiting. Treatments may be prescribed to patients with asymptomatic lymphomas. Many patients with lymphoma also have chronic diseases. Treatment may be prescribed or recommended for such conditions.

Unverified Answer

Can lymphoma, follicular be cured?

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Lymphoma (especially [follicular lymphoma](https://www.withpower.com/clinical-trials/follicular-lymphoma)) can be cured in large part. Many patients will remain free of symptoms for years. The disease will not reoccur; however the possibility that residual disease existed before the therapy exists. Patients with relapsing disease, more advanced stage, and high risk features should continue therapy for a full course to eradicate disease and prevent recurrence. Patients who are cured, however, are often free of symptoms with minimal medication.

Unverified Answer

How many people get lymphoma, follicular a year in the United States?

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The American Cancer Society estimated that there are 23,950 new lymphoma, follicular cases that will be diagnosed in the year 2016, making it the 6th most common cancer among women. These numbers are still highly debated within the scientific literature, because most people do not seek a medical examination in cases in which symptoms are present.

Unverified Answer

What is lymphoma, follicular?

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The vast majority of primary MALT lymphomas arise in the small intestine; they are often associated with chronic intestinal infection. The follicular lymphomas of MALT are generally a chronic condition. They most commonly occur in people older than 50.\n

Unverified Answer

How serious can lymphoma, follicular be?

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Data from a recent study is valuable because it provides information on the likelihood of lymphoma treatment outcome and how it may be predicted using clinical and histopathologic factors.

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Is obinutuzumab typically used in combination with any other treatments?

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Recent findings suggest that obinutuzumab does not significantly improve EFS, PFS or OS when used on its own as an induction agent for follicular lymphoma, but may improve OS when used in combination with brentuximab vedotin or rituximab.

Unverified Answer

How does obinutuzumab work?

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The FDA granted a pivotal path to OBIN for the initial treatment of CLL. This trial had the longest ever randomized assessment of treatment duration and outcomes in CLL patients. Based on these data and additional Phase 3 studies, the FDA granted a label change to shorten treatment to 12 weeks for all patients. Additional clinical trials are currently underway after this change. The FDA was able to use the 12-week duration as a surrogate and indicator for the longer duration. This is important with CLL. The 12-week treatment time point has been used to gauge the success of the treatment which should assure compliance. Based on these trials, it should be reasonable to expect treatment duration to be progressively shorter.

Unverified Answer

Have there been any new discoveries for treating lymphoma, follicular?

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Patients with [follicular lymphoma](https://www.withpower.com/clinical-trials/follicular-lymphoma) have the same 5-year survival rates as those with diffuse-type follicular lymphoma. These survival rates are similar to reports for other types of lymphoma. Because there is no difference in progression-free survival, the 5-year progression-free survival rate of patients with low-grade follicular lymphoma is also similar to the rest of the lymphoma population.

Unverified Answer

Who should consider clinical trials for lymphoma, follicular?

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Patients with non-Hodgkin's lymphoma should consider participation in clinical trials for cancer treatments. If they do not, the current guidelines that advise against clinical trials should be reconsidered.

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Does obinutuzumab improve quality of life for those with lymphoma, follicular?

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Obincutuzumab improved QoL in patients with follicular NHL after a median follow up of 24.5 months, with a trend toward improvement in QoL at 12 months. The efficacy of obinutuzumab did not correlate with prior treatment.

Unverified Answer
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