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Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Memorial Sloan Kettering Cancer Center
Sponsor:
Collaborators:
Seattle Genetics, Inc.
University of Rochester
City of Hope Medical Center
Stanford University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01868451
First received: May 30, 2013
Last updated: October 11, 2016
Last verified: October 2016

May 30, 2013
October 11, 2016
May 2013
May 2017   (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).
  • complete responses (all cohorts) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Evaluate the rate of PET-negative complete responses after completion of the treatment program (8 weeks (+/- 2 weeks) after completion of radiotherapy).
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).
Complete list of historical versions of study NCT01868451 on ClinicalTrials.gov Archive Site
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.
  • 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.
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Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
A Pilot Study of Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
The purpose of this study is to compare the outcomes across the 4 different treatment groups. The investigators hope that this treatment will improve the ability to cure more patients with HL and also limit the long-term side effects from the treatment. Although eliminating radiation in cohort 4 will eliminate the risk for long-term side effects from radiation, it is also possible that with BV+AVD chemotherapy alone there may be an increased risk of the Hodgkin lymphoma coming back after initial treatment.
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Interventional
Not Provided
Allocation: Non-Randomized
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
  • Drug: Dacarbazine
  • Radiation: Involved-Site Radiation Therapy (ISRT)
  • Procedure: Interim PET
  • Radiation: consolidation volume RT (CVRT)
  • Experimental: Cohort 1 (completed accrual)
    Patients received 4 cycles of brentuximab vedotin & 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, & 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. Involved site radiotherapy should be initiated from 12 days to 42 days after completion of chemotherapy. It is mandatory to administer prophylactic growth factor support (Neupogen) starting with cycle 1.
    Interventions:
    • Drug: Brentuximab vedotin (SGN-35)
    • Drug: Doxorubicin HCL
    • Drug: Vinblastine Sulfate
    • Drug: Dacarbazine
    • Radiation: Involved-Site Radiation Therapy (ISRT)
    • Procedure: Interim PET
  • Experimental: Cohort 2
    Patients with early stage, unfavorable risk Hodgkin lymphoma. The definition of disease bulk, one of the unfavorable risk features, has been updated, and is defined as the presence of any lymph node mass with transverse maximal diameter > 7.0 cm OR coronal maximal diameter > 7.0 cm. Patients will receive 4 cycles of brentuximab vedotin & 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 & 15 of each 28 day cycle. This may be followed by 20 Gy involved site radiotherapy.
    Interventions:
    • Drug: Brentuximab vedotin (SGN-35)
    • Drug: Doxorubicin HCL
    • Drug: Vinblastine Sulfate
    • Drug: Dacarbazine
    • Radiation: Involved-Site Radiation Therapy (ISRT)
    • Procedure: Interim PET
  • Experimental: Cohort 3
    Eligible patients will have early stage, unfavorable risk classical Hodgkin lymphoma with disease bulk defined as the presence of any lymph node mass with transverse maximal diameter > 7.0 cm or coronal maximal diameter > 7.0 cm. 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 30.6 Gy CVRT.
    Interventions:
    • Drug: Brentuximab vedotin (SGN-35)
    • Drug: Doxorubicin HCL
    • Drug: Vinblastine Sulfate
    • Drug: Dacarbazine
    • Procedure: Interim PET
    • Radiation: consolidation volume RT (CVRT)
  • Experimental: Cohort 4
    Eligible patients will have early stage, unfavorable risk classical Hodgkin lymphoma with disease bulk defined as the presence of any lymph node mass with transverse maximal diameter > 7.0 cm or coronal maximal diameter > 7.0 cm. In this cohort. 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.
    Interventions:
    • Drug: Brentuximab vedotin (SGN-35)
    • Drug: Doxorubicin HCL
    • Drug: Vinblastine Sulfate
    • Drug: Dacarbazine
    • 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
117
May 2017
May 2017   (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
  • Disease bulk defined as any lymph node mass with transverse maximal diameter > 7.0 cm OR coronal maximal diameter > 7.0 cm on CT imaging
  • 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 < 40%
  • ANC≤1000/μl and Platelets≤75,000/μl
  • Total bilirubin ≥ 2.0 mg/dl in the absence of a history of Gilbert's disease
  • Serum creatinine clearance of <30 mL/min as estimated by the Cockcroft-Gault Method
  • 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 chronic treatment with systemic steroids. However, patients can receive up to 10 days of steroid therapy prior to starting treatment with BV+AVD.
Both
18 Years to 60 Years   (Adult)
No
Contact: Craig Moskowitz, MD 212-639-2696
Contact: Joachim Yahalom, MD 212-639-5999
United States
 
NCT01868451
13-034
Yes
Not Provided
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Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
  • Seattle Genetics, Inc.
  • University of Rochester
  • City of Hope Medical Center
  • Stanford University
Principal Investigator: Craig Moskowitz, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
October 2016

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