Clinical Trial 18361

Cancer Type: Malignant Hematology
Interventions:Adcetris (Brentuximab vedotin); Adriamycin (doxorubicin); Brentuximab vedotin; DTIC (Dacarbazine); Dacarbazine; SGN-35 (Brentuximab vedotin)

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Celeste Bello

Overview

Study Title

Brentuximab Vedotin Plus AD in Non-bulky Limited Stage Hodgkin Lymphoma

Summary

The purpose of this study is to see whether brentuximab in combination with Adriamycin and Dacarbazine (AD) is effective in treating Hodgkin Lymphoma.

Objective

Primary Objective: To investigate the clinical activity of Brentuximab with AD in untreated non-bulky stage I and II Classical Hodgkin Lymphoma (cHL). Secondary Objective: To describe the safety and tolerability of Brentuximab combined with AD in previously untreated non-bulky limited stage cHL.

Inclusion Criteria

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  • Previously untreated stage IA, IB, or IIA classical Hodgkin Lymphoma
  • Non-bulky disease defined as less than 10 cm in maximal diameter
  • Measurable disease ≥1.5 cm
  • Age ≥18
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Participants must have initial organ and marrow function defined as: Absolute neutrophil count (ANC) ≥ 1,000/mcL; Platelets ≥100,000/mcL; Total bilirubin ≤ 2, unless due to Gilbert's disease; AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional upper limit of normal (ULN); Creatinine clearance ≥ 30 mL/min
  • Left ventricular ejection fraction (LVEF) by echocardiogram or multigated acquisition (MUGA) within institutional normal limits
  • Participant must be willing to use two effective forms of birth control during protocol therapy. Men and women must continue using two effective forms of birth control for 6 months following treatment.
  • Ability to understand and the willingness to sign a written informed consent document

  • Exclusion Criteria

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  • Participants who have had prior classical Hodgkin lymphoma (cHL) directed chemotherapy or radiotherapy
  • Participants may not be receiving any other investigational agents
  • Participants with known central nervous system (CNS) involvement of lymphoma
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Adriamycin, Dacarbazine, or brentuximab
  • Pre-existing grade 2 or greater neuropathy
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Women who are pregnant or nursing
  • Participants with a history of a different malignancy are ineligible unless they have been disease free for 1 year and considered at low risk for relapse, except for: cervical cancer in situ, ductal carcinoma in situ, localized prostate cancer with no detectable disease by imaging studies, and non-melanoma cancers of the skin, which are eligible at any time.
  • Known HIV positivity