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Monoclonal Antibodies

Chemotherapy for Hodgkin's Lymphoma (BV-ICE Trial)

Phase 1 & 2

Waitlist Available

Led By Ajay Gopal

Research Sponsored by University of Washington

Eligibility Criteria Checklist

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

Must have

Absolute neutrophil count (ANC) >= 1,500/uL, performed within 28 days prior to registration

Patients must have primary refractory or first relapse of cluster of differentiation 30 (CD30)+ Hodgkin lymphoma

Must not have

Patients with evidence of active central nervous system lymphoma

Patients with known allergy, intolerance, or resistance (i.e., remission duration less than 6 months or lack of response) to ifosfamide, carboplatin, or etoposide

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 days following the second course of chemotherapy, approximately 70 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying brentuximab vedotin in combination with ifosfamide, carboplatin, and etoposide to see how well they work in treating patients with relapsed or refractory Hodgkin lymphoma.

Who is the study for?

This trial is for patients with Hodgkin lymphoma that hasn't responded to initial treatment or has returned. They must have a certain level of blood cells, organ function, and be able to complete two chemotherapy cycles. Pregnant individuals, those with HIV or other recent cancers (except some skin and in situ cancers), allergies to specific drugs used here, active central nervous system lymphoma, prior brentuximab vedotin use, significant neuropathy or heart issues are excluded.

What is being tested?

The study is testing the combination of brentuximab vedotin (a targeted cancer drug) with ifosfamide, carboplatin, and etoposide (chemotherapy drugs). It aims to find the safest dose of brentuximab vedotin that can be given alongside these chemotherapies to treat relapsed/refractory Hodgkin lymphoma more effectively.

What are the potential side effects?

Potential side effects include reactions at the infusion site; damage to blood cells leading to increased infection risk; fatigue; nausea; hair loss from chemotherapy; nerve damage causing numbness or tingling sensations; liver enzyme changes suggesting potential liver impact.

Eligibility Criteria

Inclusion Criteria

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

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My white blood cell count is healthy.

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My Hodgkin lymphoma is not responding to initial treatment or has returned and tests positive for CD30.

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I have a tumor that can be seen on scans or felt and is confirmed by a PET scan.

Exclusion Criteria

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

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I have active lymphoma in my brain or spinal cord.

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I am allergic or did not respond well to ifosfamide, carboplatin, or etoposide.

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I have previously received brentuximab vedotin treatment.

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I do not have severe health issues that would prevent me from receiving strong chemotherapy.

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I am not pregnant or nursing and agree to use effective birth control.

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My nerve damage does not severely affect my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28 days following the second course of chemotherapy, approximately 70 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 28 days following the second course of chemotherapy, approximately 70 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days following the second course of chemotherapy, approximately 70 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum Tolerated Dose of Brentuximab Vedotin That Can be Combined With Ifosfamide, Carboplatin, and Etoposide Chemotherapy

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

3Treatment groups

Experimental Treatment

Group I: Phase II: Dose Expansion (brentuximab 1.5mg/kg, ifosfamide, carboplatin, etoposide)Experimental Treatment5 Interventions

Patients receive brentuximab vedotin 1.5mg/kgIV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician.

Group II: Phase I: Dose Escalation, Dose Level 2 (brentuximab 1.5mg/kg, ifosfamide, carboplatin, etoposide)Experimental Treatment5 Interventions

Group III: Phase I: Dose Escalation, Dose Level 1 (brentuximab 1.2mg/kg, ifosfamide, carboplatin, etoposide)Experimental Treatment5 Interventions

Patients receive brentuximab vedotin 1.2mg/kgIV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brentuximab Vedotin

2015

Completed Phase 3

~1080

Carboplatin

2014

Completed Phase 3

~6120