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Phase 2 Study of Rituximab-ABVD in Classical Hodgkin Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00369681
Recruitment Status : Completed
First Posted : August 29, 2006
Results First Posted : July 3, 2015
Last Update Posted : August 27, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description
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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.


Condition or disease Intervention/treatment Phase
Lymphoma Drug: Bleomycin Biological: Rituximab Drug: Dacarbazine Drug: Doxorubicin Drug: Vinblastine Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Hodgkin's Lymphoma
Study Start Date : May 2006
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Bleomycin
Other Name: Blenoxane

Biological: Rituximab
Other Name: Rituxan

Drug: Dacarbazine
Other Names:
  • DTIC
  • DTIC-Dome

Drug: Doxorubicin
Other Name: Adriamycin

Drug: Vinblastine
Other Names:
  • Velban
  • Alkaban


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00369681


Locations
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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 at Johns Hopkins
National Cancer Institute (NCI)
Investigators
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Study Chair: Yvette L. Kasamon, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
More Information
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Publications:

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00369681    
Other Study ID Numbers: J0615
P30CA006973 ( U.S. NIH Grant/Contract )
NA_00002473 ( Other Identifier: Johns Hopkins Medicine IRB )
First Posted: August 29, 2006    Key Record Dates
Results First Posted: July 3, 2015
Last Update Posted: August 27, 2018
Last Verified: July 2018
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
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:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Doxorubicin
Dacarbazine
Bleomycin
Vinblastine
Antineoplastic Agents, Immunological
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, Alkylating
Alkylating Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators