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Phase II Trial of Rituximab -ABVD for Classical Hodgkin's Disease

Phase 2
18 Years
Open (Enrolling)

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Trial Information

Phase II Trial of Rituximab -ABVD for Classical Hodgkin's Disease



- Investigate plasma DNA biomarkers, including plasma clonal immunoglobulin DNA, tumor
suppressor gene methylation, and Epstein-Barr virus DNA, in patients receiving
rituximab and doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine (ABVD)
for newly diagnosed stage II-IV classical Hodgkin's lymphoma.

- Characterize the impact of rituximab on these markers.

- Characterize the relationship between marker detection and clinical outcome.


- Estimate the event-free survival of patients with newly diagnosed Hodgkin's lymphoma
treated with rituximab and ABVD.

- Assess the presence of Hodgkin's lymphoma stem cells in peripheral blood mononuclear
cells at baseline, after treatment with rituximab, and after treatment with ABVD.

- Assess whether plasma DNA biomarkers add information to fludeoxyglucose F 18 positron
emission tomography (FDG-PET) in assessing tumor response.

OUTLINE: Patients receive doxorubicin hydrochloride IV, vinblastine IV, bleomycin IV, and
dacarbazine IV (ABVD) on days 1 and 15 of all courses. Patients also receive rituximab IV on
days -6, 1, 8, 15, and 22 of ABVD course 1 and on day 1 only of ABVD courses 2, 4, and 6.
Treatment repeats every 28 days for 6-8 courses in the absence of disease progression or
unacceptable toxicity.

Patients with bulky disease may undergo radiotherapy.

Plasma samples are obtained during treatment for investigation of tumor markers (e.g.,
immunoglobulin rearrangement, patterns of DNA methylation, and the presence of Epstein-Barr
virus DNA). Patients undergo fludeoxyglucose F18 positron emission tomography periodically
during the study.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed classical Hodgkin's lymphoma

- No lymphocyte-predominant histology

- Stage II, III, or IV disease

- Newly diagnosed disease


- Performance status 0-2

- Creatinine < 2.0 mg/dL

- Bilirubin < 5 mg/dL

- Not pregnant or nursing

- No HIV positivity

- Hepatitis B surface antigen negative

- No active concurrent malignancy except for superficial nonmelanoma skin cancer or
cervical carcinoma in situ


- No prior chemotherapy or radiotherapy for Hodgkin's lymphoma

- Steroids allowed if medically required before chemotherapy initiation

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Impact of rituximab on plasma DNA biomarkers

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Yvette L. Kasamon, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:

J0615 CDR0000492792



Start Date:

May 2006

Completion Date:

Related Keywords:

  • Lymphoma
  • stage II adult Hodgkin lymphoma
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • adult lymphocyte depletion Hodgkin lymphoma
  • adult mixed cellularity Hodgkin lymphoma
  • adult nodular sclerosis Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma



Mayo Clinic Cancer Center Rochester, Minnesota  55905
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
City of Hope Comprehensive Cancer Center Duarte, California  91010