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

Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01868451
• Other study ID #: 13-034
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2013
• Est. completion date: May 2026

Study information

• Verified date: July 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 118
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Intervention

Drug:
• Brentuximab vedotin (SGN-35)

• Doxorubicin HCL

• Vinblastine Sulfate

• Dacarbazine

Radiation:
• Involved-Site Radiation Therapy (ISRT)

Procedure:
• Interim PET

Radiation:
• consolidation volume RT (CVRT)

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	City of Hope	Duarte	California
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	University of Rochester Medical Center	Rochester	New York
United States	Stanford University Medical Center	Stanford	California
United States	Memorial Sloan Kettering Nassau	Uniondale	New York

Sponsors (5)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	City of Hope Medical Center, Seagen Inc., Stanford University, University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	development of significant pulmonary toxicity	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).	1 year
Primary	complete responses (all cohorts)	Evaluate the rate of PET-negative complete responses after completion of the treatment program (8 weeks (+/- 2 weeks) after completion of radiotherapy).	1 year
Secondary	Evaluate the prognostic significance	(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.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center