Brentuximab for Newly Diagnosed Hodgkin Disease

October 24, 2023 updated by: Mitchell Cairo

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Valhalla, New York, United States, 10595
        • New York Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 29 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Risk
Low Risk Patients (Stage IA, IIA; no bulky disease or extension): 3 cycles of chemotherapy
Drug: Brentuximab Vedotin
Day 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg)
Other Names:
  • Adcetris
Drug: Doxorubicin
Days: 1 and 15 Dose: 25 mg/m2/dose.
Other Names:
  • Doxil, Adriamycin
Drug: Vincristine
Days: 1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).
Other Names:
  • Oncovin
Experimental: Intermediate Risk
Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy
Drug: Brentuximab Vedotin
Day 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg)
Other Names:
  • Adcetris
Drug: Doxorubicin
Days: 1 and 15 Dose: 25 mg/m2/dose.
Other Names:
  • Doxil, Adriamycin
Drug: Vincristine
Days: 1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).
Other Names:
  • Oncovin
Drug: Rituximab
Days: 2 and 16 Dose: 375 mg/m2/dose.
Other Names:
  • Rituxan
Experimental: High Risk
High Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy
Drug: Brentuximab Vedotin
Day 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg)
Other Names:
  • Adcetris
Drug: Doxorubicin
Days: 1 and 15 Dose: 25 mg/m2/dose.
Other Names:
  • Doxil, Adriamycin
Drug: Vincristine
Days: 1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).
Other Names:
  • Oncovin
Drug: Rituximab
Days: 2 and 16 Dose: 375 mg/m2/dose.
Other Names:
  • Rituxan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
To determine the response rate
Time Frame: 1 year
disease evaluations will be performed after the 2nd, 4th and 6th cycles.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitchell Cairo

Investigators

  • Principal Investigator: Jessica Hochberg, MD, New York Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

March 15, 2015

First Submitted That Met QC Criteria

March 24, 2015

First Posted (Estimated)

March 25, 2015

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NYMC-568

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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