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Monoclonal Antibodies

Brentuximab Vedotin + R-CHP for Non-Hodgkin's Lymphoma (BV mini CHP Trial)

Phase 2

Waitlist Available

Led By Patrick M Reagan, MD

Research Sponsored by Patrick Reagan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Composite lymphoma containing both indolent and large cell features

Men and women aged greater than or equal to 75 years of age

Must not have

Receiving peritoneal dialysis or hemodialysis

New York Heart Association class III heart failure or ejection fraction < 30% on echocardiogram or Multi Gated Acquisition Scan (MUGA)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a new way to treat elderly patients with DLBCL by combining brentuximab vedotin with R-CHP.

Who is the study for?

This trial is for men and women aged 75 or older with a specific type of blood cancer called DLBCL. They must be able to consent, have an ECOG performance status of 0-3, no prior therapy for their condition (except possibly prednisone), and adequate liver function. People with certain other health conditions or treatments are excluded.

What is being tested?

The study tests a combination of drugs: brentuximab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone in elderly patients with DLBCL. It modifies the standard R-CHOP regimen by omitting vincristine due to its overlapping toxicities with brentuximab vedotin.

What are the potential side effects?

Potential side effects include nerve damage (neuropathy), reactions related to infusions, changes in blood counts leading to increased infection risk or bleeding problems, liver issues from elevated enzymes/bilirubin levels, fatigue and various digestive symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lymphoma has both slow-growing and aggressive features.

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I am 75 years old or older.

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I can care for myself but may not be able to do heavy physical work.

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My cancer has changed its form and this was confirmed by a biopsy. I haven't received any treatment that includes anthracyclines.

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My diagnosis of DLBCL is confirmed by a specialist.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on dialysis.

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My heart's pumping ability is significantly reduced.

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My kidney function is low, with a creatinine clearance under 30 mL/min.

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I have had an organ transplant or a related lymph disorder.

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I have been treated with anthracycline before.

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I do not have another active cancer that could affect the study results.

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I have moderate to severe numbness, tingling, or pain in my hands or feet.

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I have had a stem cell transplant from a donor.

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I have or had lymphoma in my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent of Subjects Completing Regimen

Secondary study objectives

Complete Response Rate

Overall Response Rate

Overall Survival

+1 more

Other study objectives

Mean change in objective physical performance

Number of participants with any documented change in the Older Americans Resources and Services social resources assessment.

Number of participants with impairment in physical function

+3 more

Side effects data

From 2017 Phase 2 trial • 10 Patients • NCT01807598

40%

Fatigue

30%

Neutropenia

20%

Constipation

20%

Abdominal Pain

20%

Cough

20%

Anorexia

20%

Anemia

20%

Depression

20%

Diarrhea

20%

Dyspnea

20%

Infusion Related Reaction

20%

Rash

20%

Vomiting

10%

Respiratory, thoracic and mediastinal disorders - Other, Epiglottitis

10%

Thrombocytopenia

10%

Hyperhidrosis

10%

Intracranial hemorrhage

10%

Sinusitis

10%

Oral pain

10%

Edema limbs

10%

Portal vein thrombosis

10%

Pleural effusion

10%

Fever

10%

Nausea

10%

Alopecia

10%

Dry skin

10%

Pruritus

10%

Upper respiratory infection

10%

Vaginal infection

10%

Sore throat

10%

Hypoalbuminemia

10%

Ascites

10%

Dysphagia

10%

Wound infection

10%

Postnasal drip

10%

Dehydration

10%

Insomnia

10%

Ear pain

10%

Watering eyes

10%

Pain in extremity

10%

Urinary frequency

100%

80%

60%

40%

20%

Study treatment Arm

Brentuximab Vedotin

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: BV+mini-R-CHPExperimental Treatment5 Interventions

Brentuximab vedotin 1.8 mg/kg IV day 1 for six cycles Rituximab 375 mg/m2 IV day 1 for six cycles Cyclophosphamide 400 mg/m2 IV day 1for six cycles Doxorubicin 25 mg/m2 IV day 1 for six cycles Prednisone 40 mg/m1 PO days 1-5 for six cycles

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brentuximab vedotin

2012

Completed Phase 4

~210

Cyclophosphamide

2010

Completed Phase 4

~2310