Phase 2 Study of Rituximab-ABVD in Classical Hodgkin Lymphoma

NCT ID: NCT00369681

Last Updated: 2018-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2014-10-31

Brief Summary

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.

Detailed Description

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

R-ABVD

ABVD (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.

Group Type: EXPERIMENTAL

Bleomycin

Intervention Type: DRUG

Rituximab

Intervention Type: BIOLOGICAL

Dacarbazine

Intervention Type: DRUG

Doxorubicin

Intervention Type: DRUG

Vinblastine

Intervention Type: DRUG

Interventions

Bleomycin

Intervention Type: DRUG

Rituximab

Intervention Type: BIOLOGICAL

Dacarbazine

Intervention Type: DRUG

Doxorubicin

Intervention Type: DRUG

Vinblastine

Intervention Type: DRUG

Other Intervention Names

Blenoxane; Rituxan; DTIC; DTIC-Dome; Adriamycin; Velban; Alkaban

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yvette L. Kasamon, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Countries

United States

References

Kasamon YL, Jacene HA, Gocke CD, Swinnen LJ, Gladstone DE, Perkins B, Link BK, Popplewell LL, Habermann TM, Herman JM, Matsui WH, Jones RJ, Ambinder RF. Phase 2 study of rituximab-ABVD in classical Hodgkin lymphoma. Blood. 2012 May 3;119(18):4129-32. doi: 10.1182/blood-2012-01-402792. Epub 2012 Feb 16.

Reference Type: BACKGROUND

PMID: 22343727 (View on PubMed)

Other Identifiers

P30CA006973

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00002473

Identifier Type: OTHER

Identifier Source: secondary_id

J0615

Identifier Type: -

Identifier Source: org_study_id