Clinical Trials /

Brentuximab for Newly Diagnosed Hodgkin Disease

NCT02398240

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).

Related Conditions:
  • Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Brentuximab for Newly Diagnosed Hodgkin Disease
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: NYMC-568
  • NCT ID: NCT02398240

Conditions

  • Hodgkin Lymphoma

Interventions

DrugSynonymsArms
Brentuximab VedotinAdcetrisLow Risk
DoxorubicinDoxil, AdriamycinLow Risk
VincristineOncovinLow Risk
RituximabRituxanIntermediate Risk

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Low RiskExperimentalLow Risk Patients (Stage IA, IIA; no bulky disease or extension): 3 cycles of chemotherapy
  • Brentuximab Vedotin
  • Doxorubicin
  • Vincristine
Intermediate RiskExperimentalIntermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy
  • Brentuximab Vedotin
  • Doxorubicin
  • Vincristine
  • Rituximab
High RiskExperimentalHigh Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy
  • Brentuximab Vedotin
  • Doxorubicin
  • Vincristine
  • Rituximab

Eligibility Criteria

        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

Primary Outcome Measures

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

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Mitchell Cairo

Last Updated

March 11, 2019