A Phase 2 Single Arm Study To Evaluate Safety And Preliminary Efficacy Of Nivolumab Plus AVD In Pediatric, Adolescent, And Young Adult Patients With Newly Diagnosed Early-Stage Non-Bulky Classical Hodgkin Lymphoma
M.D. Anderson Cancer Center
Summary
The goal of this clinical research study is to learn if nivolumab plus AVD (doxorubicin, vinblastine, and dacarbazine) can help to control newly diagnosed early-stage non-bulky cHL in pediatric, adolescent, and young adult patients. The safety of this drug combination will also be studied.
Description
Primary Objectives: To characterize the clinical preliminary efficacy of Nivolumab plus AVD in Pediatric, Adolescent, And Young Adult Patients with newly diagnosed early-stage non-bulky classical Hodgkin lymphoma based upon the overall response rate (ORR). To assess the safety of Nivolumab plus AVD in Pediatric, Adolescent, And Young Adult Patients with newly diagnosed early-stage non-bulky classical Hodgkin lymphoma. To summarize the incidence, prevalence, and severity of adverse drug reactions according to common terminology criteria for adverse events (CTCAE) NCI CTCAE version 5.0. Seco…
Eligibility
- Age range
- 2–21 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 2 year to 21 years 2. Newly diagnosed early-stage (I/II) non-bulky (\<10cm) classical Hodgkin lymphoma 3. Baseline ejection fraction must be \> 40% 4. Adequate hepatic function (direct bilirubin \< 1.5x upper limit of normal (ULN) unless increase is due to Gilbert's disease or lymphoma involvement, and AST and/or ALT \< 3x ULN unless considered due to lymphoma involvement, in which case direct bilirubin \< 3x ULN or AST and/or ALT \< 5x ULN will be considered eligible) 5. Adequate renal function (creatinine clearance ≥ 30 mL/min) unless related to disease 6. ECOG…
Interventions
- DrugNivolumab
Given by IV
- DrugDoxorubicin Hydrochloride
Given by IV
- DrugVinblastine
Given by IV
- DrugDacarbazine
Given by IV
Location
- UT MD AndersonHouston, Texas