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Completed

NCT Number: NCT00369681

Phase 2 Study of Rituximab-ABVD in Classical Hodgkin Lymphoma

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.

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

City of Hope Comprehensive Cancer Center, Duarte, California, United States

Loading trial locations.

About this study

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Histologically confirmed classical Hodgkin's lymphoma
  • No lymphocyte-predominant histology
  • Stage II, III, or IV disease
  • Newly diagnosed disease

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy for Hodgkin's lymphoma
  • Steroids allowed if medically required before chemotherapy initiation

Treatment and study plan

Bleomycin

Drug

Other names: Blenoxane

Rituximab

Biological

Other names: Rituxan

Dacarbazine

Drug

Other names: DTIC, DTIC-Dome

Doxorubicin

Drug

Other names: Adriamycin

Vinblastine

Drug

Other names: Velban, Alkaban

Primary outcomes

  1. Effect of Rituximab on EBV(+) Tumors

    Time frame: Up to 56 months

    Number of relapses among participants who had tumors positive for Epstein-Barr virus (EBV).

  2. 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 outcomes

  1. Event-free Survival

    Time frame: 3 years

    Percentage of participants who did not experience death, relapse, or progression (worsening) of their lymphoma.

  2. Addition of Information to Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) by Plasma DNA Biomarkers

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2014
Study completion
2014
First posted
Aug 29, 2006
Registry last updated
Aug 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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