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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology ( Cancer and Leukemia Group B )
ClinicalTrials.gov Identifier:
NCT00553501
First received: November 2, 2007
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Lymphoma
Biological: epratuzumab
Biological: rituximab
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Extended Induction Epratuzumab (Anti-CD22 Monoclonal Antibody) (CALGB IND #XXXXX) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL)

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Number of Participants With Overall Response [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    Overall response is defined as achievement of a complete response (CR) or partial response (PR) as defined by the Revised Response Criteria for Malignant Lymphoma.

    CR: complete disappearance of all detectable disease PR: >=50% decrease in the sum of the product of diameters of indicator lesions



Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: Duration of study (up to 10 years) ] [ Designated as safety issue: No ]
    Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method.


Enrollment: 60
Study Start Date: March 2008
Study Completion Date: April 2014
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epratuzumab Plus Rituximab

Induction Therapy (Month 1): Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22

Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36

Biological: epratuzumab
Days 1, 8, 15, 22 and weeks 12, 20, 28, & 36: 360mg/sq m IV
Biological: rituximab
Day 3, 8, 15, 22 and weeks 12, 20, 28, & 36: 375mg/sq m IV

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00553501

  Hide Study Locations
Locations
United States, California
Kaiser Permanente Medical Office -Vandever Medical Office
San Diego, California, United States, 92120
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Connecticut
Middlesex Hospital Cancer Center
Middletown, Connecticut, United States, 06457
United States, Delaware
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States, 19958
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5001
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612-7243
United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46845
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
South Bend Clinic
South Bend, Indiana, United States, 46617
United States, Iowa
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States, 52722
United States, Maryland
Union Hospital Cancer Program at Union Hospital
Elkton MD, Maryland, United States, 21921
United States, Massachusetts
Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, United States, 02115
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Oncology Care Associates, PLLC
Saint Joseph, Michigan, United States, 49085
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
United States, Missouri
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
United States, New Hampshire
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
Concord, New Hampshire, United States, 03301
New Hampshire Oncology - Hematology, PA - Hooksett
Hooksett, New Hampshire, United States, 03106
Lakes Region General Hospital
Laconia, New Hampshire, United States, 03246
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New York
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
United States, North Carolina
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Kinston Medical Specialists
Kinston, North Carolina, United States, 28501
Iredell Memorial Hospital
Statesville, North Carolina, United States, 28677
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1240
United States, Vermont
Mountainview Medical
Berlin, Vermont, United States, 05602
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
United States, Virginia
Danville Regional Medical Center
Danville, Virginia, United States, 24541
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
Martinsville, Virginia, United States, 24115
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
United States, West Virginia
St. Mary's Regional Cancer Center at St. Mary's Medical Center
Huntington, West Virginia, United States, 25702
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Barbara W. Grant, MD University of Vermont
  More Information

Additional Information:
Publications:
Responsible Party: Alliance for Clinical Trials in Oncology ( Cancer and Leukemia Group B )
ClinicalTrials.gov Identifier: NCT00553501     History of Changes
Other Study ID Numbers: CDR0000572604, U10CA031946, CALGB-50701
Study First Received: November 2, 2007
Results First Received: June 26, 2014
Last Updated: September 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Alliance for Clinical Trials in Oncology:
stage II grade 1 follicular lymphoma
stage II grade 2 follicular lymphoma
stage II grade 3 follicular lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014