Phase 2 N=45 Treatment

Brentuximab Vedotin, Ifosfamide, Carboplatin, and Etoposide in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

Recurrent Hodgkin Lymphoma · Refractory Hodgkin Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT02227199 ↗

Enrolled (actual)

Serious AEs

26.7%

Results posted

Jun 2021

Primary outcome: Primary: Maximum Tolerated Dose of Brentuximab Vedotin That Can be Combined With Ifosfamide, Carboplatin, and Etoposide Chemotherapy — 1.5 mg/kg

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Brentuximab Vedotin (Drug); Carboplatin (Drug); Etoposide (Drug); Ifosfamide (Drug); Laboratory Biomarker Analysis (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Washington
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Tolerated Dose of Brentuximab Vedotin That Can be Combined With Ifosfamide, Carboplatin, and Etoposide Chemotherapy	1.5	—
PRIMARY Percentage of Patients That Achieve a Complete Remission Following Study Treatment	3; 3; 26	—
SECONDARY 2 Year Overall Survival	3; 3; 37	—
SECONDARY 2 Year Progression-free Survival	2; 3; 33	—

Summary

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

Inclusion Criteria

Patients must have primary refractory or first relapse of cluster of differentiation 30 (CD30)+ Hodgkin lymphoma
Patients must have measurable disease defined as lesions that can be accurately measured in two dimensions by computed tomography (CT), magnetic resonance imaging (MRI), medical photograph (skin or oral lesion), plain x-ray, or other conventional technique and a greatest transverse diameter of 1 cm or greater; or palpable lesions with both diameters >= 2 cm; further, at least 1 of these lesions must be positive by positron emission tomography (PET) scan (i.e., Deauville score of 4 or more); Note: CT scans remain the standard for evaluation of nodal disease
Patients must have a CT of chest, abdomen, and pelvis with PET within 28 days of enrollment; patients with evidence of lymphadenopathy in the neck must have a dedicated CT of neck
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (performance status of 2 will be allowed if poor performance status is thought to be directly secondary to patient's Hodgkin lymphoma [HL])
Absolute neutrophil count (ANC) >= 1, 500/uL, performed within 28 days prior to registration
Platelets >= 100, 000/uL (without transfusion or growth factor support), performed within 28 days prior to registration
Serum creatinine 60 mL/min, performed within 28 days prior to registration
Total bilirubin grade 1
Patients who have other medical conditions that would contraindicate treatment with aggressive chemotherapy (including active infection, uncontrolled hypertension, congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, or uncontrolled arrhythmia); if the patient's cardiac history is questionable, a measurement of left ventricular ejection fraction should be obtained within 42 days prior to registration; patients with left ventricular ejection fraction < 50% are not eligible
Prior failed (< 5 x 10^6 CD34/kg) peripheral blood stem cell (PBSC) collection
Patients who had pelvic radiation within 12 months
Previous chemotherapy/immunotherapy within 3 weeks before study entry
Concurrent use of other anti-cancer agents or experimental treatments

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02227199). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.