Clincosm LogoSign in Get a demo

Brentuximab for Newly Diagnosed Hodgkin Disease

Sponsor
Mitchell Cairo (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02398240
Collaborator
(none)
40
Enrollment
1
Location
3
Arms
79
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 1, 2015
Actual Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To determine if this combination of chemoimmunotherapy is safe to administer. (Adverse events) [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 [1 year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 29 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New York Medical College Valhalla New York United States 10595

    Sponsors and Collaborators

    • Mitchell Cairo

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mitchell Cairo, Executive Vice Chair, New York Medical College
    ClinicalTrials.gov Identifier:
    NCT02398240
    Other Study ID Numbers:
    • NYMC-568
    First Posted:
    Mar 25, 2015
    Last Update Posted:
    Nov 2, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Hodgkin Disease
    Rituximab
    Brentuximab Vedotin
    Doxorubicin
    Vincristine

    Study Results

    No Results Posted as of Nov 2, 2021