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OpenTrials
Completed

NCT Number: NCT02398240

Brentuximab for Newly Diagnosed Hodgkin Disease

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).

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Key information

Conditions

Hodgkin Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

1 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New York Medical College

Valhalla, New York, 10595, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brentuximab Vedotin

Drug

Day 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg)

Other names: Adcetris

Doxorubicin

Drug

Days: 1 and 15 Dose: 25 mg/m2/dose.

Other names: Doxil, Adriamycin

Vincristine

Drug

Days: 1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).

Other names: Oncovin

Rituximab

Drug

Days: 2 and 16 Dose: 375 mg/m2/dose.

Other names: Rituxan

Primary outcomes

  1. 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

  2. To determine the response rate

    Time frame: 1 year

    disease evaluations will be performed after the 2nd, 4th and 6th cycles.

Sponsors and collaborators

Lead sponsor

Mitchell Cairo

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Mar 25, 2015
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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