Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Hodgkin's Lymphoma

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center Identifier:
First received: August 24, 2006
Last updated: July 27, 2015
Last verified: July 2015

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with newly diagnosed stage II, stage III, or stage IV Hodgkin's lymphoma.

Condition Intervention Phase
Biological: bleomycin
Biological: rituximab
Drug: ABVD regimen
Drug: dacarbazine
Drug: doxorubicin
Drug: vinblastine
Genetic: DNA methylation analysis
Other: laboratory biomarker analysis
Radiation: fludeoxyglucose F 18
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Rituximab -ABVD for Classical Hodgkin's Disease

Resource links provided by NLM:

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Impact of Rituximab on Plasma DNA Biomarkers [ Time Frame: 5 years ]
  • Relationship Between Marker Detection and Clinical Outcome [ Time Frame: 3 years ]
    Number of relapses for participants who did and did not have re-emergence of clonal CD27(+) ALDH(+) B cells after completing study intervention.

Secondary Outcome Measures:
  • Event-free Survival [ Time Frame: 3 years ]
    Percentage of participants who did not experience death, relapse, or progression (worsening) of their lymphoma.

  • Addition of Information to Fludeoxyglucose F 18 Positron Emission Tomography (FDG-PET) by Plasma DNA Biomarkers [ Time Frame: 5 years ]

Enrollment: 50
Study Start Date: May 2006
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: R-ABVD
ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
Biological: bleomycin
Other Name: bleomycin sulfate
Biological: rituximab Drug: ABVD regimen Drug: dacarbazine Drug: doxorubicin
Other Name: doxorubicin hydrochloride; Adriamycin
Drug: vinblastine Genetic: DNA methylation analysis Other: laboratory biomarker analysis Radiation: fludeoxyglucose F 18

Detailed Description:



  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00369681

United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1009
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Yvette L. Kasamon, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sidney Kimmel Comprehensive Cancer Center Identifier: NCT00369681     History of Changes
Other Study ID Numbers: J0615 CDR0000492792
P30CA006973 ( US NIH Grant/Contract Award Number )
JHOC-J0615 ( Other Identifier: Johns Hopkins SKCCC )
JHOC-NA_00002473 ( Other Identifier: Johns Hopkins Medicine IRB )
Study First Received: August 24, 2006
Results First Received: May 20, 2015
Last Updated: July 27, 2015

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Fluorodeoxyglucose F18
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators processed this record on April 28, 2017