Non Hodgkin Lymphoma Clinical Trial

Epratuzumab and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma

Summary

RATIONALE: Monoclonal antibodies, such as epratuzumab and 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. Giving epratuzumab and rituximab together may be more effective in treating follicular non-Hodgkin lymphoma.

PURPOSE: This phase II trial is studying how well giving epratuzumab together with rituximab works in treating patients with previously untreated follicular non-Hodgkin lymphoma.

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Full Description

OBJECTIVES:

Primary

To determine the response rate (overall and complete) after extended induction therapy comprising epratuzumab and rituximab in patients with previously untreated CD20+ follicular non-Hodgkin lymphoma (NHL).
To determine the time to progression after extended induction therapy comprising epratuzumab and rituximab in patients with previously untreated CD20+ follicular NHL.

Secondary

To determine the toxicity profile of epratuzumab and rituximab in patients with previously untreated CD20+ follicular NHL.
To establish whether the therapeutic effects of the combination of epratuzumab and rituximab are sufficiently promising to warrant evaluation in a subsequent randomized trial (in comparison to rituximab alone).
To determine the relationship between the change in fludeoxyglucose F 18 uptake early after epratuzumab and rituximab treatment with response rate and time to progression.

OUTLINE:

Induction therapy (month 1): Patients receive epratuzumab IV over 5-30 minutes on days 1, 8, 15, and 22 and rituximab IV on days 3, 8, 15, and 22 in the absence of disease progression or unacceptable toxicity.
Extended induction therapy (months 3, 5, 7, and 9): Patients receive epratuzumab IV over 5-30 minutes followed by rituximab IV in weeks 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.

Patients receive fludeoxyglucose F 18 (FDG) subcutaneously and undergo positron emission tomography at baseline and after induction therapy to assess the degree of FDG uptake.

After completion of study treatment, patients are followed every 4 months for 2 years then every 6 months for up to 10 years.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically* confirmed follicular non-Hodgkin lymphoma (NHL)

Previously untreated disease
WHO classification grade 1, 2, or 3a (> 15 centroblasts per high power field with centrocytes present) that is stage III, IV, or bulky (i.e., single mass ≥ 7 cm in any unidimensional measurement) stage II disease NOTE: *Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies; fine-needle aspirates are not acceptable for diagnosis
Confirmed CD20 antigen expression by flow cytometry or immunohistochemistry

Measurable disease by physical examination or imaging studies

Any tumor mass > 1 cm is acceptable

No nonmeasurable disease only, including any of the following:

Bone lesions
Ascites
Pleural/pericardial effusion
Lymphangitis cutis/pulmonis
Bone marrow (involvement by NHL should be noted)
No known CNS involvement by lymphoma
Required to participate in companion FDG-PET imaging study CALGB 580701

PATIENT CHARACTERISTICS:

ECOG performance status ≤ 2
Absolute neutrophil count ≥ 1,000/μL
Platelet count ≥ 50,000/μL

Patients with HIV infection are eligible provided they meet the following criteria:

No evidence of coinfection with hepatitis B or C
CD4+ cell count ≥ 400/mm^3
No evidence of resistant strains of HIV
If not on anti-HIV therapy, HIV viral load < 10,000 copies HIV RNA/mL
If on anti-HIV therapy, HIV viral load < 50 copies HIV RNA/mL
No history of AIDS-defining conditions
Not pregnant or nursing
Fertile patients must use effective contraception during and for 3 months after completion of study therapy
No known Human Anti-Chimeric Antibody (HACA)-positivity

PRIOR CONCURRENT THERAPY:

No prior therapy for NHL including chemotherapy, radiotherapy, or immunotherapy (e.g., monoclonal antibody-based therapy)
More than 2 weeks since prior corticosteroids except for maintenance therapy for non-malignant disease

No concurrent dexamethasone or other steroids as antiemetics except for the following circumstances:

Treatment of acute infusion reactions according to institutional procedures
No concurrent hormonal therapy except steroids for adrenal failure OR hormones for non-disease-related conditions (e.g., insulin for diabetes)
No other concurrent chemotherapeutic agents

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT00553501

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 39 Locations for this study

See Locations Near You

Kaiser Permanente Medical Office -Vandever Medical Office
San Diego California, 92120, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94115, United States
Middlesex Hospital Cancer Center
Middletown Connecticut, 06457, United States
Tunnell Cancer Center at Beebe Medical Center
Lewes Delaware, 19958, United States
CCOP - Christiana Care Health Services
Newark Delaware, 19713, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington District of Columbia, 20007, United States
Walter Reed Army Medical Center
Washington District of Columbia, 20307, United States
University of Illinois Cancer Center
Chicago Illinois, 60612, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Elkhart General Hospital
Elkhart Indiana, 46515, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne Indiana, 46845, United States
Howard Community Hospital
Kokomo Indiana, 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte Indiana, 46350, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend Indiana, 46601, United States
Saint Joseph Regional Medical Center
South Bend Indiana, 46617, United States
South Bend Clinic
South Bend Indiana, 46617, United States
Hematology Oncology Associates of the Quad Cities
Bettendorf Iowa, 52722, United States
Union Hospital Cancer Program at Union Hospital
Elkton MD Maryland, 21921, United States
Dana-Farber/Brigham and Women's Cancer Center
Boston Massachusetts, 02115, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
Oncology Care Associates, PLLC
Saint Joseph Michigan, 49085, United States
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph Michigan, 49085, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia Missouri, 65203, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis Missouri, 63110, United States
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
Concord New Hampshire, 03301, United States
New Hampshire Oncology - Hematology, PA - Hooksett
Hooksett New Hampshire, 03106, United States
Lakes Region General Hospital
Laconia New Hampshire, 03246, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees New Jersey, 08043, United States
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse New York, 13057, United States
New York Weill Cornell Cancer Center at Cornell University
New York New York, 10021, United States
Wayne Memorial Hospital, Incorporated
Goldsboro North Carolina, 27534, United States
Kinston Medical Specialists
Kinston North Carolina, 28501, United States
Iredell Memorial Hospital
Statesville North Carolina, 28677, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem North Carolina, 27157, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus Ohio, 43210, United States
Mountainview Medical
Berlin Vermont, 05602, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington Vermont, 05401, United States
Danville Regional Medical Center
Danville Virginia, 24541, United States
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
Martinsville Virginia, 24115, United States
Virginia Commonwealth University Massey Cancer Center
Richmond Virginia, 23298, United States
St. Mary's Regional Cancer Center at St. Mary's Medical Center
Huntington West Virginia, 25702, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT00553501

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

How clear is this clinincal trial information?

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