Brentuximab Vedotin, Ifosfamide, Carboplatin, and Etoposide in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma (BV-ICE)
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|ClinicalTrials.gov Identifier: NCT02227199|
Recruitment Status : Recruiting
First Posted : August 28, 2014
Last Update Posted : January 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Adult Hodgkin Lymphoma Refractory Hodgkin Lymphoma TNFRSF8 Positive||Drug: Brentuximab Vedotin Drug: Carboplatin Drug: Etoposide Drug: Ifosfamide Other: Laboratory Biomarker Analysis||Phase 1 Phase 2|
I. To determine maximally tolerated dose of brentuximab vedotin that can be combined with ifosfamide, carboplatin and etoposide chemotherapy in patients with relapsed or refractory Hodgkin lymphoma.
II. To gain a preliminary assessment of the efficacy of the above regimen.
I. To determine the safety and toxicity of the above regimen.
II. To determine the ability to proceed to peripheral blood stem cell collection following the above regimen (the impact of above regimen on stem cell reserve).
III. To assess the impact of this regimen on biomarkers from the microenvironment in Hodgkin lymphoma tumors.
OUTLINE: This is a phase I, dose-escalation study of brentuximab vedotin followed by a phase II study.
Patients receive brentuximab vedotin intravenously (IV) 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 high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) may undergo peripheral blood stem cell (PBSC) mobilization following the 2nd course of study therapy at the discretion of the treating physician.
After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 4 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Trial of Brentuximab Vedotin (BV), Ifosfamide (I), Carboplatin (C), and Etoposide (E) for Patients With Relapsed or Refractory Hodgkin Lymphoma (BV-ICE)|
|Actual Study Start Date :||October 10, 2014|
|Estimated Primary Completion Date :||September 15, 2018|
Experimental: Treatment (brentuximab, ifosfamide, carboplatin, etoposide)
Patients receive brentuximab vedotin IV 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.
Drug: Brentuximab Vedotin
Other: Laboratory Biomarker Analysis
- Maximum tolerated dose of brentuximab vedotin that can be combined with ifosfamide, carboplatin, and etoposide chemotherapy, defined as the dose at which =< 1 of 6 patients experience a dose-limiting toxicity [ Time Frame: Up to 28 days after the last dose of study drug ]Dose-limiting toxicity will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
- Percentage of patients that achieve a complete remission following study treatment [ Time Frame: 3 weeks following the second course of chemotherapy ]
- Overall survival [ Time Frame: Up to 5 years ]Described from the time of initiation of study therapy and from ASCT (for those who go on to receive this treatment).
- Progression-free survival [ Time Frame: Up to 5 years ]Described from the time of initiation of study therapy and from autologous stem cell transplantation (ASCT) (for those who go on to receive this treatment).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227199
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Ajay K. Gopal 206-606-2037 email@example.com|
|Principal Investigator: Ajay K. Gopal|
|Principal Investigator:||Ajay Gopal||Fred Hutch/University of Washington Cancer Consortium|