Clinical trial NCT01868451: Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
Official title: A Pilot Study of Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hodgkin Lymphoma
Keywords: DACARBAZINE
DOXORUBICIN/ADRIAMYCIN
SGN-35 (BRENTUXIMAB VEDOTIN)
VINBLASTINE
Involved-site radiation therapy (ISRT)
Early stage
13-034
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Seagen Inc.
name: University of Rochester
name: City of Hope Medical Center
name: Stanford University
First posted: 2013-06-04
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: development of significant pulmonary toxicity
timeFrame: 1 year
measure: complete responses (all cohorts)
timeFrame: 1 year
Secondary outcomes:
measure: Evaluate the prognostic significance
timeFrame: 1 year
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Anita Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumar A, Casulo C, Advani RH, Budde E, Barr PM, Batlevi CL, Caron P, Constine LS, Dandapani SV, Drill E, Drullinsky P, Friedberg JW, Grieve C, Hamilton A, Hamlin PA, Hoppe RT, Horwitz SM, Joseph A, Khan N, Laraque L, Matasar MJ, Moskowitz AJ, Noy A, Palomba ML, Schoder H, Straus DJ, Vemuri S, Yang J, Younes A, Zelenetz AD, Yahalom J, Moskowitz CH. Brentuximab Vedotin Combined With Chemotherapy in Patients With Newly Diagnosed Early-Stage, Unfavorable-Risk Hodgkin Lymphoma. J Clin Oncol. 2021 Jul 10;39(20):2257-2265. doi: 10.1200/JCO.21.00108. Epub 2021 Apr 28.
citation: Kumar A, Casulo C, Yahalom J, Schoder H, Barr PM, Caron P, Chiu A, Constine LS, Drullinsky P, Friedberg JW, Gerecitano JF, Hamilton A, Hamlin PA, Horwitz SM, Jacob AG, Matasar MJ, McArthur GN, McCall SJ, Moskowitz AJ, Noy A, Palomba ML, Portlock CS, Straus DJ, VanderEls N, Verwys SL, Yang J, Younes A, Zelenetz AD, Zhang Z, Moskowitz CH. Brentuximab vedotin and AVD followed by involved-site radiotherapy in early stage, unfavorable risk Hodgkin lymphoma. Blood. 2016 Sep 15;128(11):1458-64. doi: 10.1182/blood-2016-03-703470. Epub 2016 Jul 25.