Trial Summary
What is the purpose of this trial?This phase I/II trial studies the side effects and best dose of brentuximab vedotin that can be combined with ifosfamide, carboplatin, and etoposide in treating patients with Hodgkin lymphoma that has come back (relapsed) or is not responding to treatment (refractory). Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells. Chemotherapy drugs, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving brentuximab vedotin together with an ifosfamide, carboplatin, and etoposide chemotherapy regimen may kill more cancer cells.
Eligibility Criteria
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.Inclusion Criteria
I have a tumor that can be seen on scans or felt and is confirmed by a PET scan.
Aspartate aminotransferase (AST) < 2.5 times upper limit of normal, performed within 28 days prior to registration
All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
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Exclusion Criteria
I have previously received brentuximab vedotin treatment.
I haven't had chemotherapy or immunotherapy in the last 3 weeks.
Concurrent use of other anti-cancer agents or experimental treatments
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Participant Groups
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.
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
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 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.
Brentuximab Vedotin is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Adcetris for:
- Hodgkin lymphoma
- Systemic anaplastic large cell lymphoma
- Primary cutaneous anaplastic large cell lymphoma
- CD30-expressing mycosis fungoides
- Peripheral T-cell lymphoma
🇪🇺 Approved in European Union as Adcetris for:
- Hodgkin lymphoma
- Systemic anaplastic large cell lymphoma
- Cutaneous T-cell lymphoma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Fred Hutch/University of Washington Cancer ConsortiumSeattle, WA
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Who Is Running the Clinical Trial?
University of WashingtonLead Sponsor
National Cancer Institute (NCI)Collaborator
Seagen Inc.Industry Sponsor