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Chemotherapy

Nivolumab + Chemo-Immunotherapy for Large B-Cell Lymphoma

Phase 3
Recruiting
Led By Lisa G Roth
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 2 years
Patient must have histologically confirmed primary mediastinal B-cell lymphoma (PMBCL) as defined by World Health Organization (WHO) criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights

Study Summary

This trial is testing nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone to see how well they work in treating PMBCL.

Who is the study for?
This trial is for people with newly diagnosed primary mediastinal B-cell lymphoma. Eligible participants include children over 2 years old and adults with good kidney function, no severe liver issues unrelated to lymphoma, and a stable heart condition. HIV-positive patients can join if they have an undetectable viral load. Pregnant women, breastfeeding mothers, those with active autoimmune diseases or infections, and individuals who've had certain recent cancer treatments are excluded.Check my eligibility
What is being tested?
The study tests nivolumab combined with chemo-immunotherapy against chemo-immunotherapy alone in treating primary mediastinal B-cell lymphoma. Nivolumab is an immunotherapy drug that may help the immune system fight cancer by stopping cancer cells from growing.See study design
What are the potential side effects?
Potential side effects of nivolumab and other drugs used in this trial might include allergic reactions to the medication, increased risk of infection due to weakened immunity, fatigue, possible damage to organs like the liver or kidneys from chemotherapy drugs, and heart complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at least 2 years old.
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My lymphoma is confirmed as PMBCL by WHO standards.
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My kidney function, measured by creatinine clearance or GFR, is good.
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My kidney function, measured by creatinine, is within the normal range for my age and gender.
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I am between 2 and 6 years old with a creatinine level at or below 0.8 mg/dL.
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I am between 6 and 9 years old with a creatinine level of 1 or less.
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I am between 10 and 12 years old with a creatinine level at or below 1.2 mg/dL.
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I am between 13 and 16 years old with a creatinine level below the gender-specific limit.
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I am between 16 and 18 years old with a creatinine level below the gender-specific limit.
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I am 18 or older with a healthy heart pump function.
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I am under 18 and my heart functions well according to tests.
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My hepatitis B virus load is undetectable with treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Efficacy-related event-free survival
Overall survival
Positron-Emission Tomography
+1 more
Other outcome measures
Complete response rate
Immune profile of patients treated with nivolumab + chemo-immunotherapy

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Arm F (R-CHOP, nivolumab, radiation therapy)Experimental Treatment15 Interventions
Patients receive treatment as in Arm D. Within 6-8 weeks after completion of chemotherapy, patients undergo radiation therapy over 25 fractions. Patients undergo ECHO during screening and as clinically indicated and LP for CSF collection optionally during screening. Patients also undergo CT or PET/CT throughout the trial. Additionally, patients undergo bone marrow biopsy and aspiration optionally during screening and as clinically indicated on study. Patients undergo blood sample collection on study.
Group II: Arm D (R-CHOP, nivolumab)Experimental Treatment15 Interventions
Patients receive treatment as in Arm C. Patients also receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (5 if the patient had 1 prior cycle of treatment) in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening and as clinically indicated and LP for CSF collection optionally during screening. Patients also undergo CT or PET/CT throughout the trial. Additionally, patients undergo bone marrow biopsy and aspiration optionally during screening and as clinically indicated on study. Patients undergo blood sample collection on study.
Group III: Arm B (DA-EPOCH-R, nivolumab)Experimental Treatment18 Interventions
Patients receive treatment as in Arm A. Patients also receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (5 if the patient had 1 prior cycle of treatment) in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO and LP for CSF collection during screening. Patients undergo ECHO during screening and as clinically indicated and LP for CSF collection optionally during screening. Patients also undergo CT or PET/CT throughout the trial. Additionally, patients undergo bone marrow biopsy and aspiration optionally during screening and as clinically indicated on study. Patients undergo blood sample collection on study.
Group IV: Arm C (R-CHOP)Active Control14 Interventions
Patients receive prednisone or prednisolone PO QD on days 1-5 and rituximab IV or rituximab and hyaluronidase human SC over 5 minutes on day 1 or 5. Patients also receive cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV over 1-15 minutes or up to 60 minutes, and vincristine sulfate IV over 1 or up to 60 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (5 if the patient had 1 prior cycle of treatment) in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening and as clinically indicated and LP for CSF collection optionally during screening. Patients also undergo CT or PET/CT throughout the trial. Additionally, patients undergo bone marrow biopsy and aspiration optionally during screening and as clinically indicated on study. Patients undergo blood sample collection on study.
Group V: Arm A (DA-EPOCH-R)Active Control17 Interventions
See Detailed Description
Group VI: Arm E (R-CHOP, radiation therapy)Active Control15 Interventions
Patients receive treatment as in Arm C. Within 6-8 weeks after completion of chemotherapy, patients undergo radiation therapy over 25 fractions. Patients undergo ECHO during screening and as clinically indicated and LP for CSF collection optionally during screening. Patients also undergo CT or PET/CT throughout the trial. Additionally, patients undergo bone marrow biopsy and aspiration optionally during screening and as clinically indicated on study. Patients undergo blood sample collection on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Lumbar Puncture
2016
Completed Phase 3
~510
Positron Emission Tomography
2008
Completed Phase 2
~2240
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Echocardiography
2013
Completed Phase 4
~11670
Computed Tomography
2017
Completed Phase 2
~2720
Biospecimen Collection
2004
Completed Phase 2
~1700
Cyclophosphamide
1995
Completed Phase 3
~3770
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Filgrastim
2000
Completed Phase 3
~3670
Pegfilgrastim
2013
Completed Phase 3
~4410
Prednisone
2014
Completed Phase 4
~2370
Rituximab
1999
Completed Phase 4
~1880
Etoposide Phosphate
2011
Completed Phase 2
~160
Nivolumab
2014
Completed Phase 3
~4750
Prednisolone
2005
Completed Phase 4
~2720
Radiation Therapy
2017
Completed Phase 3
~7250
Vincristine Sulfate
2005
Completed Phase 3
~10150

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,664 Previous Clinical Trials
40,925,889 Total Patients Enrolled
Lisa G RothPrincipal InvestigatorChildren's Oncology Group

Media Library

Cyclophosphamide (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04759586 — Phase 3
Large B-Cell Lymphoma Research Study Groups: Arm C (R-CHOP), Arm A (DA-EPOCH-R), Arm D (R-CHOP, nivolumab), Arm F (R-CHOP, nivolumab, radiation therapy), Arm B (DA-EPOCH-R, nivolumab), Arm E (R-CHOP, radiation therapy)
Large B-Cell Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT04759586 — Phase 3
Cyclophosphamide (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04759586 — Phase 3

Frequently Asked Questions

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

What are the conditions that would lead a doctor to prescribe Radiation Therapy?

"While synovitis is not the only condition that Radiation Therapy can be used to treat, it is one of the more common ones. Other issues like scalp structure, prostate cancer, and squamous cell carcinoma can also benefit from this type of treatment."

Answered by AI

Did the FDA endorse radiation treatments?

"Safety is always our primary concern. That being said, we feel confident in giving Radiation Therapy a 3 out of 3. This is based on the fact that this treatment is currently in Phase 3 trials."

Answered by AI

What is the efficacy of Radiation Therapy in other cancer treatment trials?

"There are presently 2577 clinical trials underway studying Radiation Therapy. 499 of these live studies are in Phase 3, with the majority based in Bethesda, Maryland. However, there are a total of 102523 locations running studies for this treatment worldwide."

Answered by AI

Who else is applying?

What site did they apply to?
Janeway Child Health Centre
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma
2021. "Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04759586.
~159 spots leftby Dec 2028
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