Description:
The addition of Brentuximab vedotin (Bv) to combination chemotherapy will be safe, well tolerated and effective in children, adolescents and young adults with all stages of newly diagnosed Hodgkin lymphoma (HL).
The addition of Brentuximab vedotin (Bv) to combination chemotherapy will be safe, well tolerated and effective in children, adolescents and young adults with all stages of newly diagnosed Hodgkin lymphoma (HL).
Recruiting
Phase 2
Drug | Synonyms | Arms |
---|---|---|
Brentuximab Vedotin | Adcetris | High Risk |
Doxorubicin | Doxil, Adriamycin | High Risk |
Vincristine | Oncovin | High Risk |
Rituximab | Rituxan | High Risk |
Name | Type | Description | Interventions |
---|---|---|---|
Low Risk | Experimental | Low Risk Patients (Stage IA, IIA; no bulky disease or extension): 3 cycles of chemotherapy |
|
Intermediate Risk | Experimental | Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy |
|
High Risk | Experimental | High Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy |
|
Inclusion Criteria: - Normal Serum creatinine based on age or creatinine clearance >60 ml/min/1.73 m2 or an equivalent radioisotope glomerular filtration rate (GFR) as determined by the institutional normal range. - Direct bilirubin < 1.5 upper limit of normal (ULN) for age, and SGOT (AST) or SGPT (ALT) <3 x ULN - Shortening fraction >27% by echocardiogram, or - Ejection fraction of >50% by radionuclide angiogram or echocardiogram. - For patients age 1-16 years, Lansky score of ≥60. - For patients > 16 years, Karnofsky score of ≥60. - No prior Hodgkin lymphoma directed therapy is allowed except for emergent mediastinal irradiation (<1000cGy) for superior vena cava (SVC) syndrome. Exclusion Criteria: - Females who are pregnant (positive HCG) or lactating. - Karnofsky <60% or Lansky <60% if less than 16 years of age. - Age ≤1 year or >29.99 years of age.
Maximum Eligible Age: | 29 Years |
Minimum Eligible Age: | 1 Year |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | To determine if this combination of chemoimmunotherapy is safe to administer. (Adverse events) |
Time Frame: | 1 year |
Safety Issue: | |
Description: | Adverse events will be monitored each cycle to determine if there are any events related possibly, probably or definitely related to study therapy |
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Mitchell Cairo |
February 27, 2020