Brentuximab Vedotin Combined With AVD Chemotherapy and 30 Gray Involved-Site Radiotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
Seattle Genetics, Inc.
University of Rochester
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01868451
First received: May 30, 2013
Last updated: April 23, 2014
Last verified: April 2014

May 30, 2013
April 23, 2014
May 2013
May 2015   (final data collection date for primary outcome measure)
development of significant pulmonary toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
specifically non-infectious pneumonitis The definition of unacceptable pulmonary toxicity will be defined as the development of grade 2 or higher pneumonitis as defined by Common Terminology Criteria for Adverse Events (CTCAE version 4).
Same as current
Complete list of historical versions of study NCT01868451 on ClinicalTrials.gov Archive Site
  • progression-free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Progression free survival (PFS) will be calculated from the time of initiation of brentuximab vedotin.
  • Evaluate the prognostic significance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    (i.e. correlation with progression free survival) of interim fluorodeoxyglucose-positron emission tomography (PET) in this patient population measured by visual analysis and semi-quantitative analysis.
  • Evaluate the prognostic significance of gene-expression based predictor [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    using NanoString technology
  • Evaluate the prognostic significance of gene-expression of plasma Epstein Barr virus DNA (EBV-DNA) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    by quantitative PCR,
  • progression-free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Progression free survival (PFS) will be calculated from the time of initiation of brentuximab vedotin.
  • Evaluate the prognostic significance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    (i.e. correlation with progression free survival) of interim fluorodeoxyglucose-positron emission tomography (PET) in this patient population measured by visual analysis and semi-quantitative analysis.
Not Provided
Not Provided
 
Brentuximab Vedotin Combined With AVD Chemotherapy and 30 Gray Involved-Site Radiotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
A Pilot Study of Brentuximab Vedotin Combined With AVD Chemotherapy and 30 Gray Involved-Site Radiotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma

The purpose of this study is to find out whether BV with AVD chemotherapy and radiation is a safe and effective treatment. It is hoped that this treatment will improve the ability to cure more patients with HL.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hodgkin Lymphoma
  • Drug: Brentuximab vedotin (SGN-35)
  • Drug: Doxorubicin HCL
  • Drug: Vinblastine Sulfate
  • Device: Dacarbazine
  • Radiation: Involved-Site Radiation Therapy (ISRT)
  • Procedure: Interim PET
Experimental: Pts with Hodgkin Lymphoma
Patients will receive 4 cycles of brentuximab vedotin and AVD chemotherapy. Brentuximab vedotin, 1.2 mg/kg, will be administered on days 1 and 15 of each 28 day cycle. Doxorubicin 25 mg/m2, Vinblastine 6 mg/m2, and Dacarbazine 375 mg/m2 will be administered on days 1 and 15 of each 28 day cycle. This may be followed by 30 Gy involved site radiotherapy.
Interventions:
  • Drug: Brentuximab vedotin (SGN-35)
  • Drug: Doxorubicin HCL
  • Drug: Vinblastine Sulfate
  • Device: Dacarbazine
  • Radiation: Involved-Site Radiation Therapy (ISRT)
  • Procedure: Interim PET
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
May 2015
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologic diagnosis of classical, CD30 positive Hodgkin lymphoma confirmed at enrolling institution
  • FDG-avid disease by FDG-PET/CT and measurable disease of at least 1.5 cm by CT
  • Ann Arbor Stage I or II disease
  • At least one of the following unfavorable risk factors as defined by GHSG: bulky mediastinal mass (≥one-third maximum transverse thoracic diameter on Posterior-Anterior/Lateral Chest X-ray or ≥10cm by CT imaging in axial plane), ESR ≥ 50mm/h or ESR ≥30 mm/h in patients with "B" symptoms, extranodal involvement, or 3 or more involved lymph node sites.
  • Females of childbearing age must be on an acceptable form of birth control per institutional standards
  • Age between 18 and 60

Exclusion Criteria:

  • Cardiac ejection fraction ≤ 50%
  • Hemoglobin-adjusted diffusing capacity for carbon monoxide < 60%
  • ANC≤1000/μl and Platelets≤75,000/μl
  • Total bilirubin ≥ 2.0 mg/dl in the absence of a history of Gilbert's disease
  • Known pregnancy or breast-feeding
  • Medical illness unrelated to Hodgkin Lymphoma, which, in the opinion of the attending physician and/or MSKCC principal investigator, makes participation in this study inappropriate.
  • Peripheral neuropathy > grade 1
  • Patients receiving treatment with systemic steroids
Both
18 Years to 60 Years
No
Contact: Craig Moskowitz, MD 212-639-2696
Contact: Joachim Yahalom, MD 212-639-5999
United States
 
NCT01868451
13-034
Yes
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • Seattle Genetics, Inc.
  • University of Rochester
Principal Investigator: Craig Moskowitz, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP