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Monoclonal Antibodies

Brentuximab Vedotin + CHEP for Adult T-Cell Leukemia/Lymphoma

Phase 2

Waitlist Available

Led By Dittus Christopher, DO, MPH

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years at the time of consent

Histological confirmation of biopsy-proven peripheral T-cell leukemia/lymphoma consistent with ATLL

Must not have

Previous exposure to brentuximab vedotin (BV)

Symptomatic cardiac disease including ventricular dysfunction, left ventricular ejection fraction < 40%, symptomatic coronary artery disease or symptomatic arrhythmias

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well BV-CHEP works in treating patients with ATLL.

Who is the study for?

This trial is for adults over 18 with a specific type of cancer called Adult T-cell leukemia/lymphoma (ATLL), who have not been treated or have had only one round of chemotherapy. They must test negative for HIV, show adequate organ function, and if they can bear children, agree to use effective contraception methods. People with severe liver or kidney problems, active brain lymphoma lesions, certain other cancers, allergies to the study drugs or components, taking prohibited medications, previous brentuximab vedotin treatment, significant neuropathy or symptomatic heart disease are excluded.

What is being tested?

The trial tests an investigational treatment named BV-CHEP which combines brentuximab vedotin (an FDA-approved drug for some lymphomas) with standard chemotherapy drugs cyclophosphamide, doxorubicin, etoposide and prednisone. The aim is to see if this combination works better in patients whose ATLL cells express CD30 protein markers.

What are the potential side effects?

Potential side effects include reactions related to the immune system's response such as inflammation in various organs; infusion-related reactions; fatigue; digestive issues like nausea and diarrhea; blood disorders that could affect cell counts leading to increased infection risk; potential nerve damage causing numbness or tingling.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My biopsy confirms I have peripheral T-cell leukemia/lymphoma.

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I have tested positive for HTLV-1 with confirmatory tests.

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My kidney and liver functions are within the required range.

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My cancer cells show CD30 presence.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

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

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I have been treated with brentuximab vedotin before.

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I have heart problems that cause symptoms.

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My liver is not working well (Child-Pugh Score > 6).

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My kidneys are not working well (creatinine clearance ≤ 30 mL/min).

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I do not have severe nerve damage.

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My brain scans show a lesion that may be active lymphoma.

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I have another cancer that is growing and needs treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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

Cyclophosphamide

Secondary study objectives

Duration of response to BV-CHEP in patients with adult T-cell leukemia/lymphoma who received or did not receive BV maintenance.

Overall response rate (ORR) associated with 2-6 cycles of BV-CHEP therapy in patients with adult T-Cell leukemia/lymphoma.

Overall survival (OS) of patients with adult T-cell leukemia/lymphoma treated with BV-CHEP who received or did not receive BV maintenance therapy.

+2 more

Side effects data

From 2018 Phase 3 trial • 131 Patients • NCT01578499

47%

Peripheral sensory neuropathy

36%

Nausea

27%

Diarrhoea

27%

Fatigue

17%

Vomiting

17%

Pruritus

15%

Alopecia

15%

Decreased appetite

14%

Pyrexia

12%

Myalgia

12%

Arthralgia

11%

Asthenia

11%

Oedema peripheral

11%

Rash maculo-papular

11%

Dyspnoea

11%

Pruritus generalised

Paraesthesia

Pain in extremity

Weight decreased

Hypertension

Dysgeusia

Headache

Urticaria

Neutropenia

Hyperglycaemia

Peripheral motor neuropathy

Dizziness

Chills

Upper respiratory tract infection

Hyperuricaemia

Urinary tract infection

Muscle spasms

Anaemia

Constipation

Alanine aminotransferase increased

Skin infection

Insomnia

Cough

Cellulitis

Neuropathy peripheral

Multiple organ dysfunction syndrome

Drug eruption

Cancer pain

Diverticulitis

Sepsis

Impetigo

Sinusitis

Extravasation

General physical health deterioration

Musculoskeletal chest pain

Hypotension

Dry skin

Peripheral swelling

Hypertriglyceridaemia

Lower respiratory tract infection

Fracture

Lymphoma

Neck pain

Hepatocellular injury

Intestinal perforation

Haemolytic uraemic syndrome

Pancreatitis

Pulmonary embolism

Urinary retention

Stress

Aspartate aminotransferase increased

Staphylococcal skin infection

100%

80%

60%

40%

20%

Study treatment Arm

Brentuximab Vedotin

Methotrexate or Bexarotene

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: Open-label, Multicenter, Single-ArmExperimental Treatment2 Interventions

This is a single-arm intervention where patients will receive concurrent therapy with BV+CHEP \[(brentuximab vedotin; 1.8 mg/kg IV, on D1 every 21 days) (cyclophosphamide 750 mg/m\^2 on D1; doxorubicin 50 mg/m\^2 on D1, etoposide 100 mg/m\^2 IV infusion on D1-3; prednisone 100 mg orally once daily on D1-5; cycle length every 21 days)\] for 2 to 6 cycles of induction therapy. After 6 cycles of BV + CHEP, responders (CR, PR or SD) who are not eligible for BMT and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV, every 21 days) until disease progression, withdrawal due to toxicity or death.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brentuximab Vedotin

2015

Completed Phase 3

~1080

0 / 13Eligibility criteria met