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

• Register: ClinicalTrials.gov
• Last refreshed on: 18 July 2023
• Main ID: NCT01868451
• Date of registration: 30/05/2013
• Prospective Registration: No
• Primary sponsor: Memorial Sloan Kettering Cancer Center
• Public title: Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
• Scientific title: A Pilot Study of Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
• Date of first enrolment: May 2013
• Target sample size: 118
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT01868451
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Anita Kumar, MD
• Affiliation: Memorial Sloan Kettering Cancer Center

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hodgkin Lymphoma

Intervention(s)

Drug: Dacarbazine

Procedure: Interim PET

Radiation: consolidation volume RT (CVRT)

Drug: Vinblastine Sulfate

Radiation: Involved-Site Radiation Therapy (ISRT)

Drug: Brentuximab vedotin (SGN-35)

Drug: Doxorubicin HCL

Primary Outcome(s)

development of significant pulmonary toxicity [Time Frame: 1 year]

complete responses (all cohorts) [Time Frame: 1 year]

Secondary Outcome(s)

Evaluate the prognostic significance [Time Frame: 1 year]

Secondary ID(s)

13-034

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Stanford University

City of Hope Medical Center

Seagen Inc.

University of Rochester