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

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ClinicalTrials.gov Identifier: NCT01868451
Recruitment Status : Active, not recruiting
First Posted : June 4, 2013
Last Update Posted : June 3, 2022
Sponsor:
Collaborators:
Seagen Inc.
University of Rochester
City of Hope Medical Center
Stanford University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
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) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
Actual Study Start Date : May 2013
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 starting with cycle 1. Choice of growth factor and dosing can be determined at the discretion of the treating physican.
 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.
 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
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.
 Drug: Brentuximab vedotin (SGN-35)
Drug: Doxorubicin HCL
Drug: Vinblastine Sulfate
Drug: Dacarbazine
Procedure: Interim PET
Radiation: consolidation volume RT (CVRT)
Experimental: Cohort 4
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. Pts will receive 4 cycles of brentuximab vedotin & AVD chemo. Brentuximab vedotin, 1.2 mg/kg, will be administered on days 1 & 15 of each 28 day cycle. Doxorubicin 25 mg/m2, Vinblastine 6 mg/m2, & Dacarbazine 375 mg/m2 will be administered on days 1 & 15 of each 28 day cycle. Pts whose PET scan is negative after 4 cycles of brentuximab vedotin & AVD chemotherapy will not receive RT. Pts whose PET scan is positive after 4 cycles of brentuximab vedotin & AVD chemo, but subsequent biopsy is neg, will also receive no RT. Upon MSK PI approval, if the simulation can't be covered by the institution or the pts insurance, a diagnostic IV contrast CT neck & diagnostic IV contrast CT CAP scan will be done in addition to the FDG-PET done after 4 cycles of chemo.
 Drug: Brentuximab vedotin (SGN-35)
Drug: Doxorubicin HCL
Drug: Vinblastine Sulfate
Drug: Dacarbazine
Procedure: Interim PET


Outcome Measures
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Primary Outcome Measures :
  1. development of significant pulmonary toxicity [ Time Frame: 1 year ]
    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).

  2. complete responses (all cohorts) [ Time Frame: 1 year ]
    Evaluate the rate of PET-negative complete responses after completion of the treatment program (8 weeks (+/- 2 weeks) after completion of radiotherapy).


Secondary Outcome Measures :
  1. Evaluate the prognostic significance [ Time Frame: 1 year ]
    (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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Ages 18 and over

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
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • 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.
Contacts and Locations
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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): NCT01868451


Locations
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United States, California
City of Hope
Duarte, California, United States, 91010
Stanford University Medical Center
Stanford, California, United States, 94305-5408
United States, New Jersey
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Memoral Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
United States, New York
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
University of Rochester Medical Center
Rochester, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Seagen Inc.
University of Rochester
City of Hope Medical Center
Stanford University
Investigators
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Principal Investigator: Anita Kumar, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01868451    
Other Study ID Numbers: 13-034
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: June 3, 2022
Last Verified: June 2022
Keywords provided by Memorial Sloan Kettering Cancer Center:
DACARBAZINE
DOXORUBICIN/ADRIAMYCIN
SGN-35 (BRENTUXIMAB VEDOTIN)
VINBLASTINE
 Involved-site radiation therapy (ISRT)
Early stage
13-034
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Doxorubicin
Liposomal doxorubicin
Brentuximab Vedotin
Dacarbazine
Vinblastine
 Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators