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Brentuximab for Newly Diagnosed Hodgkin Disease

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ClinicalTrials.gov Identifier: NCT02398240
Recruitment Status : Recruiting
First Posted : March 25, 2015
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
Mitchell Cairo, New York Medical College

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
Hodgkin Lymphoma Drug: Brentuximab Vedotin Drug: Doxorubicin Drug: Vincristine Drug: Rituximab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : May 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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 Name: Adcetris

Drug: Doxorubicin
Days: 1 and 15 Dose: 25 mg/m2/dose.
Other Name: Doxil, Adriamycin

Drug: Vincristine
Days: 1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).
Other Name: 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 Name: Adcetris

Drug: Doxorubicin
Days: 1 and 15 Dose: 25 mg/m2/dose.
Other Name: Doxil, Adriamycin

Drug: Vincristine
Days: 1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).
Other Name: Oncovin

Drug: Rituximab
Days: 2 and 16 Dose: 375 mg/m2/dose.
Other Name: 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 Name: Adcetris

Drug: Doxorubicin
Days: 1 and 15 Dose: 25 mg/m2/dose.
Other Name: Doxil, Adriamycin

Drug: Vincristine
Days: 1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).
Other Name: Oncovin

Drug: Rituximab
Days: 2 and 16 Dose: 375 mg/m2/dose.
Other Name: Rituxan




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   1 Year to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02398240


Contacts
Contact: Jessica Hochberg, MD 9145942132 jessica_hochberg@nymc.edu
Contact: Mitchell Cairo, MD 9145942150 mitchell_cairo@nymc.edu

Locations
United States, New York
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Mitchell S Cairo, MD    914-594-2150    mitchell_cairo@nymc.edu   
Contact: Lauren Harrison, MSN    6172857844    lauren_harrison@nymc.edu   
Sponsors and Collaborators
Mitchell Cairo
Investigators
Principal Investigator: Jessica Hochberg, MD New York Medical College

Responsible Party: Mitchell Cairo, Executive Vice Chair, New York Medical College
ClinicalTrials.gov Identifier: NCT02398240     History of Changes
Other Study ID Numbers: NYMC-568
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Doxorubicin
Vincristine
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators