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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
epratuzumab
rituximab
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Permanente Medical Office -Vandever Medical Office
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • Middlesex Hospital Cancer Center
  • Tunnell Cancer Center at Beebe Medical Center
  • CCOP - Christiana Care Health Services
  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
  • Walter Reed Army Medical Center
  • University of Illinois Cancer Center
  • University of Chicago Cancer Research Center
  • Elkhart General Hospital
  • Fort Wayne Medical Oncology and Hematology
  • Howard Community Hospital
  • Center for Cancer Therapy at LaPorte Hospital and Health Services
  • CCOP - Northern Indiana CR Consortium
  • Memorial Hospital of South Bend
  • Saint Joseph Regional Medical Center
  • South Bend Clinic
  • Hematology Oncology Associates of the Quad Cities
  • Union Hospital Cancer Program at Union Hospital
  • Dana-Farber/Brigham and Women's Cancer Center
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • Oncology Care Associates, PLLC
  • Lakeland Regional Cancer Care Center - St. Joseph
  • Ellis Fischel Cancer Center at University of Missouri - Columbia
  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
  • New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
  • New Hampshire Oncology - Hematology, PA - Hooksett
  • Lakes Region General Hospital
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  • Cancer Institute of New Jersey at Cooper - Voorhees
  • CCOP - Hematology-Oncology Associates of Central New York
  • New York Weill Cornell Cancer Center at Cornell University
  • Wayne Memorial Hospital, Incorporated
  • Kinston Medical Specialists
  • Iredell Memorial Hospital
  • Wake Forest University Comprehensive Cancer Center
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
  • Mountainview Medical
  • Fletcher Allen Health Care - University Health Center Campus
  • Danville Regional Medical Center
  • Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
  • Virginia Commonwealth University Massey Cancer Center
  • St. Mary's Regional Cancer Center at St. Mary's Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Epratuzumab Plus Rituximab

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Participants With Overall Response
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
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.

Full Information

First Posted
November 2, 2007
Last Updated
July 1, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00553501
Brief Title
Epratuzumab and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epratuzumab Plus Rituximab
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
epratuzumab
Intervention Description
Days 1, 8, 15, 22 and weeks 12, 20, 28, & 36: 360mg/sq m IV
Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Description
Day 3, 8, 15, 22 and weeks 12, 20, 28, & 36: 375mg/sq m IV
Primary Outcome Measure Information:
Title
Number of Participants With Overall Response
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
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.
Time Frame
Duration of study (up to 10 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Grant, MD
Organizational Affiliation
University of Vermont
Official's Role
Study Chair
Facility Information:
Facility Name
Kaiser Permanente Medical Office -Vandever Medical Office
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Middlesex Hospital Cancer Center
City
Middletown
State/Province
Connecticut
ZIP/Postal Code
06457
Country
United States
Facility Name
Tunnell Cancer Center at Beebe Medical Center
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5001
Country
United States
Facility Name
University of Illinois Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-7243
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Elkhart General Hospital
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46515
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Howard Community Hospital
City
Kokomo
State/Province
Indiana
ZIP/Postal Code
46904
Country
United States
Facility Name
Center for Cancer Therapy at LaPorte Hospital and Health Services
City
La Porte
State/Province
Indiana
ZIP/Postal Code
46350
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Saint Joseph Regional Medical Center
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Hematology Oncology Associates of the Quad Cities
City
Bettendorf
State/Province
Iowa
ZIP/Postal Code
52722
Country
United States
Facility Name
Union Hospital Cancer Program at Union Hospital
City
Elkton MD
State/Province
Maryland
ZIP/Postal Code
21921
Country
United States
Facility Name
Dana-Farber/Brigham and Women's Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Oncology Care Associates, PLLC
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Lakeland Regional Cancer Care Center - St. Joseph
City
St. Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Ellis Fischel Cancer Center at University of Missouri - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States
Facility Name
New Hampshire Oncology - Hematology, PA - Hooksett
City
Hooksett
State/Province
New Hampshire
ZIP/Postal Code
03106
Country
United States
Facility Name
Lakes Region General Hospital
City
Laconia
State/Province
New Hampshire
ZIP/Postal Code
03246
Country
United States
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Cancer Institute of New Jersey at Cooper - Voorhees
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
CCOP - Hematology-Oncology Associates of Central New York
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
New York Weill Cornell Cancer Center at Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Wayne Memorial Hospital, Incorporated
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Kinston Medical Specialists
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Iredell Memorial Hospital
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28677
Country
United States
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Mountainview Medical
City
Berlin
State/Province
Vermont
ZIP/Postal Code
05602
Country
United States
Facility Name
Fletcher Allen Health Care - University Health Center Campus
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Danville Regional Medical Center
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
City
Martinsville
State/Province
Virginia
ZIP/Postal Code
24115
Country
United States
Facility Name
Virginia Commonwealth University Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States
Facility Name
St. Mary's Regional Cancer Center at St. Mary's Medical Center
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25702
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23922187
Citation
Grant BW, Jung SH, Johnson JL, Kostakoglu L, Hsi E, Byrd JC, Jones J, Leonard JP, Martin SE, Cheson BD. A phase 2 trial of extended induction epratuzumab and rituximab for previously untreated follicular lymphoma: CALGB 50701. Cancer. 2013 Nov 1;119(21):3797-804. doi: 10.1002/cncr.28299. Epub 2013 Aug 6.
Results Reference
result
PubMed Identifier
30575311
Citation
Lansigan F, Barak I, Pitcher B, Jung SH, Cheson BD, Czuczman M, Martin P, Hsi E, Schoder H, Smith S, Bartlett NL, Leonard JP, Blum KA. The prognostic significance of PFS24 in follicular lymphoma following firstline immunotherapy: A combined analysis of 3 CALGB trials. Cancer Med. 2019 Jan;8(1):165-173. doi: 10.1002/cam4.1918. Epub 2018 Dec 21.
Results Reference
derived

Learn more about this trial

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

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