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Non-Hodgkin's Lymphoma (NHL)Phase 2NCT01108341

Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL)

A Phase 2 study testing Bendamustine hydrochloride and Ofatumumab in people with Non-Hodgkin's Lymphoma (NHL), run by Cephalon at 39 sites in 3 countries.

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

The primary objective of the study is to determine the efficacy, as measured by overall response (complete response + partial response) of bendamustine in combination with ofatumumab in previously untreated patients with indolent B-Cell Non-Hodgkin's Lymphoma (NHL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkin's Lymphoma (NHL)
What is being tested?
Bendamustine hydrochloride and Ofatumumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
39 sitesin 3 countries
Study dates
May 2010to Oct 2011
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

Who may be able to join

  • The patient has histopathologic confirmation of one of the protocol-specific CD20+ B-cell non-Hodgkin's lymphomas. Tissue diagnostic procedures must be performed within 6 months of study entry and with biopsy material available for review.
  • The patient meets 1 of the following need-for-treatment criteria:
  • Presence of at least 1 of the following B-symptoms:
  • fever (>38ºC) of unclear etiology
  • night sweats
  • weight loss of greater than 10% within the prior 6 months
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  • large tumor mass (bulky disease) characterized by lymphomas with a diameter of more than 3 cm in 3 or more regions or by a lymphoma with a diameter of more than 7 cm in 1 region
  • presence of lymphoma-related complications
  • hyperviscosity syndrome due to monoclonal gammopathy
  • The patient's tumor is verified to be CD20+ positive from current or previous excisional or incisional tissue diagnostic procedures performed within 6 months of study entry.
  • The screening phase CT scan (based on local evaluation) shows:
  • 2 or more clearly demarcated lesions with a largest diameter ≥1.5 cm, or
  • 1 clearly demarcated lesion with a largest diameter ≥2.0 cm
  • The patient was not previously treated for indolent lymphoma (with the exception of a single course of local radiation therapy not exceeding 2 adjacent lymph node regions).
  • The patient has adequate hematologic and hepatic function.
  • The patient has Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
  • The patient has serum creatinine of 2.0 mg/dL or less or creatinine clearance of 30 mL/min or more, based on the Cockcroft-Gault method, or from a 24-hour urine collection.
  • The patient is willing to comply with contraception requirements.

Who cannot join

  • The patient:
  • Has small lymphocytic lymphoma or mantle cell lymphoma.
  • Has documented history of central nervous system (CNS) lymphomatous involvement.
  • Has or has had an active malignancy, other than NHL, within the past 3 years except for localized prostate cancer without evidence of bone metastases, bladder, cervical, or breast carcinoma in-situ, or non-melanoma skin cancer .
  • Has New York Heart Association (NYHC) Class III or IV heart failure, uncontrolled arrythmias or unstable angina, electrocardiographic evidence of active ischemia or active conduction system abnormalities, or myocardial infarction within the last 6 months.
  • Has known human immunodeficiency virus (HIV) infection.
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  • Has acute or chronic hepatitis B or hepatitis C infection.
  • Is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
  • Has any serious uncontrolled, medical or psychological disorder that would impair the ability of the subject to receive study drugs.
  • Has received another investigational agent within 30 days of study entry.
  • Has known hypersensitivity to mannitol.
  • Has Ann Arbor stage I disease.

Trial locations and contacts

39 sites in 3 countries.

39 sites in 3 countries

United States34 sites

  • Texas Oncology, P.A.

    Bedford, Texas, 76022

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211-1850

  • Birmingham Hematology and Oncology Associates, LLC

    Birmingham, Alabama, 35235

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-3300

  • Mid Dakota Clinic

    Bismarck, North Dakota, 58504

  • University Cancer Institute

    Boynton Beach, Florida, 33435

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Dublin Hematology Oncology Care P.C.

    Dublin, Georgia, 31021

  • Fairfax/Northern Virginia Hematology/Oncology

    Fairfax, Virginia, 22031

  • Cancer Centers of the Carolinas

    Greenville, South Carolina, 29605

  • Kentucky Cancer Clinic

    Hazard, Kentucky, 41701

  • MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Columbia Comprehensive Cancer Care Clinic

    Jefferson City, Missouri, 65109

  • Monter Cancer Center

    Lake Success, New York, 11042

  • Nevada Cancer Institute

    Las Vegas, Nevada, 89135

  • Longview Cancer Center

    Longview, Texas, 75601

  • Joe Arrington Cancer Research

    Lubbock, Texas, 79410

  • Northwest Georgia Oncology Center

    Marietta, Georgia, 30060

  • Texas Oncology, P.A.

    McAllen, Texas, 78503

  • The West Clinic

    Memphis, Tennessee, 38138

  • Florida Cancer Institute - New Hope

    New Port Richey, Florida, 34655

  • Cancer Care and Hematology Specialists of Chicagoland

    Niles, Illinois, 60714

  • University of Pittsburgh Medical Center - Cancer Institute

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health Sciences University

    Portland, Oregon, 97239

  • Cancer Care Centers of South Texas

    San Antonio, Texas, 78229

  • Siouxland Hematology-Oncology Assoc. LLP

    Sioux City, Iowa, 51101

  • Somerset Hematology Oncology Associates

    Somerville, New Jersey, 08876

  • Hematology Oncology, P.C.

    Stamford, Connecticut, 06902

  • Georgia Cancer Specialists

    Tucker, Georgia, 30084

  • Texas Oncology

    Waco, Texas, 76712

  • Texas Oncology, P.A.

    Webster, Texas, 77598

  • Carroll County Cancer Center

    Westminster, Maryland, 21157

  • US Oncology Research - Texoma Cancer Center

    Wichita Falls, Texas, 76310

  • Yakima Valley Memorial Hospital/North Start Lodge

    Yakima, Washington, 98902

Other trials in United States

Belgium3 sites

  • Cephalon Investigational Site

    Brussels, 1000

  • Cephalon Investigational Site

    Brussels, 1200

  • Cephalon Investigational Site

    Ghent

Other trials in Belgium

Israel2 sites

  • Cephalon Investigational Site

    Haifa, 31096

  • Cephalon Investigational Site

    Nahariya, 22100

Other trials in Israel

About this study

Official title: An Open-Label Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL)

The primary objective of the study is to determine the efficacy, as measured by overall response (complete response + partial response) of bendamustine in combination with ofatumumab in previously untreated patients with indolent B-Cell Non-Hodgkin's Lymphoma (NHL).

Being tested
Bendamustine hydrochloride, Ofatumumab
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

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

  • Bendamustine hydrochlorideDrug

    Also called CEP-18083, Treanda

    Bendamustine will be administered at 90 mg/m^2 as a 30-minute intravenous (iv) infusion on days 1 and 2 of each cycle.

  • OfatumumabDrug

    Also called Arzerra

    Ofatumumab will be administered at 300 mg as an iv infusion on day 1 and 1000 mg on day 8 of cycle 1 and 1000 mg on day 1 of each subsequent cycle.

Study groups in NCT01108341
Study groupRoleWhat they receive
Bendamustine and OfatumumabExperimentalThere are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
Receives: Drug: Bendamustine hydrochloride; Drug: Ofatumumab

What is being measured

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

  1. Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR), as Determined by the International Working Group (IWG) Criteria As Assessed by Investigators

    The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.

    Measured: up to Week 32

Secondary outcomes (1)

  1. Percentage of Participants With a Best Overall Response of Complete Response (CR), as Determined by the International Working Group (IWG) Criteria As Assessed by Investigators

    The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.

    Measured: up to Week 32

Timeline

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

  1. First posted22 Apr 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionJul 2011
  4. Study completionOct 2011

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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01108341
Sponsor's protocol ID
C18083/2048
Other IDs
2009-016725-34, 2009
Status last verified
Jul 2012
First submitted
14 Apr 2010
Last updated
28 Aug 2012
Data monitoring committee
No

Publications

  • Czuczman MS, Kahanic S, Forero A, Davis G, Munteanu M, Van Den Neste E, Offner F, Bron D, Quick D, Fowler N. Results of a phase II study of bendamustine and ofatumumab in untreated indolent B cell non-Hodgkin's lymphoma. Ann Hematol. 2015 Apr;94(4):633-41. doi: 10.1007/s00277-014-2269-8. Epub 2015 Jan 30.

    PubMed 25630297

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bendamustine hydrochloride and Ofatumumab in people with Non-Hodgkin's Lymphoma (NHL), run by Cephalon at 39 sites in 3 countries.

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

Who may be eligible to take part?

The sponsor lists 18 inclusion and 12 exclusion criteria. 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 28 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, Belgium, Israel. 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 28 Aug 2012). 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?

Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR), as Determined by the International Working Group (IWG) Criteria As Assessed by Investigators (time frame: up to Week 32). 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 NCT01108341, which also lists 1 linked publication.

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 28 Aug 2012.

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