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Avastin (Bevacizumab) in Combination With ABVD for the Treatment of Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma

Phase 2
18 Years
Open (Enrolling)
Hodgkin Lymphoma

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Trial Information

Avastin (Bevacizumab) in Combination With ABVD for the Treatment of Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma

Participants will be given Avastin as well as ABVD (Adriamycin, Bleomycin, Vinblastine and
Dacarbazine) intravenously on days 1 and 15 of a 28 day cycle. Participants will receive up
to a total of 6 cycles of therapy.

Inclusion Criteria:

- 18 years of age or older

- Biopsy proven classical Hodgkin lymphoma. Classical Hodgkin lymphoma includes the
subtypes of nodular sclerosis, mixed cellularity, lymphocyte rich, lymphocyte
depleted, and classical Hodgkin lymphoma unspecified

- Advanced stage (Stage III or IV) disease

- Measurable disease on cross sectional imaging

- ECOG Performance Status 0-2

- Adequate blood counts and organ function

Exclusion Criteria:

- Pregnant or lactating women

- Laboratory Parameters as outlined in the protocol

- LV ejection fraction lower than normal as assessed by echocardiogram or MUGA scan

- DLCO less than 60% as measured by pulmonary function tests

- Prior history of another malignancy (except for non-melanoma skin cancer or in situ
cervical or breast cancer) unless disease free for over one year

- Current or recent (within 4 weeks of the first infusion of this study) participation
in an experimental drug study

- Life expectancy of less than 12 weeks

- Inability to comply with study procedures

- Inability to give informed consent

- Inadequately controlled hypertension

- Any prior history of hypertensive crisis or hypertensive encephalopathy

- NYHA Grade II or greater congestive heart failure

- History of myocardial infarction or unstable angina within 6 months prior to study

- History of stroke or transient ischemic attack within 6 months prior to study

- Known CNS involvement of Hodgkin lymphoma

- Significant vascular disease

- Symptomatic peripheral vascular disease

- Evidence of bleeding diatheses or coagulopathy

- Use of daily anticoagulant medications including warfarin, heparins, or aspirin
>325mg daily

- Major surgical procedure or significant traumatic injury within 28 days prior to
study enrollment or anticipation of need for major surgical procedure during the
course of the study

- Core biopsy or other minor surgical procedure, excluding placement of a vascular
access device, within 7 days of study enrollment

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to study enrollment

- Serious, non-healing wound, ulcer, or bone fracture

- Proteinuria at screening

- Known hypersensitivity to any component of bevacizumab

- Pregnant or lactating

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine clinical activity and safety of bevacizumab when combined with ABVD for primary therapy of Hodgkin lymphoma

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Jeremy Abramson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

September 2008

Completion Date:

December 2014

Related Keywords:

  • Hodgkin Lymphoma
  • Avastin
  • bevacizumab
  • ABVD
  • angiogenesis
  • antiangiogenic
  • Hodgkin
  • Hodgkin Disease
  • Lymphoma



Massachusetts General Hospital Boston, Massachusetts  02114-2617