Brentuximab for Newly Diagnosed Hodgkin Disease

Overview

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).

Full Title of Study: “A Pilot Study of Risk Adapted Therapy Utilizing Upfront Brentuximab With Combination Chemotherapy in the Treatment of Children, Adolescents and Young Adults With Newly Diagnosed Hodgkin Lymphoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2020

Interventions

  • Drug: Brentuximab Vedotin
    • Day 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg)
  • Drug: Doxorubicin
    • Days: 1 and 15 Dose: 25 mg/m2/dose.
  • Drug: Vincristine
    • Days: 1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).
  • Drug: Rituximab
    • Days: 2 and 16 Dose: 375 mg/m2/dose.

Arms, Groups and Cohorts

  • Experimental: Low Risk
    • Low Risk Patients (Stage IA, IIA; no bulky disease or extension): 3 cycles of chemotherapy
  • Experimental: Intermediate Risk
    • Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy
  • Experimental: High Risk
    • High Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy

Clinical Trial Outcome Measures

Primary Measures

  • To determine if this combination of chemoimmunotherapy is safe to administer. (Adverse events)
    • Time Frame: 1 year
    • Adverse events will be monitored each cycle to determine if there are any events related possibly, probably or definitely related to study therapy
  • To determine the response rate
    • Time Frame: 1 year
    • disease evaluations will be performed after the 2nd, 4th and 6th cycles.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 29 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mitchell Cairo
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Mitchell Cairo, Executive Vice Chair – New York Medical College
  • Overall Official(s)
    • Jessica Hochberg, MD, Principal Investigator, New York Medical College
  • Overall Contact(s)
    • Jessica Hochberg, MD, 9145942132, jessica_hochberg@nymc.edu

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