AzTrials
AzTrials

LymphomaPhase 2NCT00553501

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

A Phase 2 study testing epratuzumab and rituximab in people with Lymphoma, run by Alliance for Clinical Trials in Oncology at 43 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
epratuzumab and rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
43 sitesUnited States
Study dates
Mar 2008to Jul 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

United States43 sites

  • Mountainview Medical

    Berlin Corners, Vermont, 05602

  • Hematology Oncology Associates of the Quad Cities

    Bettendorf, Iowa, 52722

  • Dana-Farber/Brigham and Women's Cancer Center

    Boston, Massachusetts, 02115

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612-7243

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

    Columbus, Ohio, 43210-1240

  • New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care

    Concord, New Hampshire, 03301

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • CCOP - Hematology-Oncology Associates of Central New York

    East Syracuse, New York, 13057

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital Cancer Program at Union Hospital

    Elkton MD, Maryland, 21921

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46845

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • New Hampshire Oncology - Hematology, PA - Hooksett

    Hooksett, New Hampshire, 03106

  • St. Mary's Regional Cancer Center at St. Mary's Medical Center

    Huntington, West Virginia, 25702

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • Howard Community Hospital

    Kokomo, Indiana, 46904

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Lakes Region General Hospital

    Laconia, New Hampshire, 03246

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, 19958

  • Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County

    Martinsville, Virginia, 24115

  • Middlesex Hospital Cancer Center

    Middletown, Connecticut, 06457

  • New York Weill Cornell Cancer Center at Cornell University

    New York, New York, 10021

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Lakeland Regional Cancer Care Center - St. Joseph

    Saint Joseph, Michigan, 49085

  • Oncology Care Associates, PLLC

    Saint Joseph, Michigan, 49085

  • Kaiser Permanente Medical Office -Vandever Medical Office

    San Diego, California, 92120

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Saint Joseph Regional Medical Center

    South Bend, Indiana, 46617

  • South Bend Clinic

    South Bend, Indiana, 46617

  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    St Louis, Missouri, 63110

  • Iredell Memorial Hospital

    Statesville, North Carolina, 28677

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5001

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1096

Other trials in United States

About this study

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)

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.

Read the 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.

Conditions
Lymphoma
Being tested
epratuzumab, rituximab
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
Medical subject headings
Lymphoma, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • epratuzumabBiological

    Days 1, 8, 15, 22 and weeks 12, 20, 28, \& 36: 360mg/sq m IV

  • rituximabBiological

    Day 3, 8, 15, 22 and weeks 12, 20, 28, \& 36: 375mg/sq m IV

Study groups in NCT00553501
Study groupRoleWhat they receive
Epratuzumab Plus RituximabExperimentalInduction 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
Receives: Biological: epratuzumab; Biological: rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 months

Secondary outcomes (1)

  1. 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.

    Measured: Duration of study (up to 10 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2007 (estimated)
  2. Study startMar 2008
  3. Primary completionJul 2010
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00553501
Sponsor's protocol ID
CALGB-50701
Other IDs
U10CA031946, CALGB-50701, CDR0000572604
Status last verified
Jul 2016
First submitted
2 Nov 2007
Last updated
6 Jul 2016
Data monitoring committee
No

Publications

  • 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.

    PubMed 23922187

  • Rutherford SC, Yin J, Pederson L, Perez Burbano G, LaPlant B, Shadman M, Li H, LeBlanc ML, Kenkre VP, Hong F, Blum KA, Dockter T, Martin P, Jung SH, Grant B, Rosenbaum C, Ujjani C, Barr PM, Unger JM, Cheson BD, Bartlett NL, Kahl B, Friedberg JW, Mandrekar SJ, Leonard JP. Relevance of Bone Marrow Biopsies for Response Assessment in US National Cancer Institute National Clinical Trials Network Follicular Lymphoma Clinical Trials. J Clin Oncol. 2023 Jan 10;41(2):336-342. doi: 10.1200/JCO.21.02301. Epub 2022 Jul 5.

    PubMed 35787017

  • 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.

    PubMed 30575311

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing epratuzumab and rituximab in people with Lymphoma, run by Alliance for Clinical Trials in Oncology at 43 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Overall Response (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00553501, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in