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Diffuse Large B-Cell LymphomaPhase 2NCT02420210

Bendamustine, Obinutuzumab, and Dexamethasone in Older Patients With Diffuse Large B-cell Lymphoma

A Phase 2 study testing Bendamustine Hydrochloride, Obinutuzumab and Dexamethasone in people with Diffuse Large B-Cell Lymphoma, run by University of Chicago at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase II trial studies how well bendamustine hydrochloride, obinutuzumab, and dexamethasone work in treating older patients with diffuse large B-cell lymphoma. Drugs used in chemotherapy, such as bendamustine hydrochloride and dexamethasone, work in different ways to stop the growth of cancer cells, either by… Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Diffuse Large B-Cell Lymphoma
What is being tested?
Bendamustine Hydrochloride, Obinutuzumab and Dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
Nov 2015to Aug 2016
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Histologically confirmed DLBCL, cluster of differentiation (CD)20 positive by flow or immunohistochemistry (IHC); transformed DLBCL is allowed as long as no prior therapy has been given
  • No prior therapy for DLBCL, except =< 1 week of corticosteroids given on an emergent basis or as a temporizing measure (pre-phase where indicated by the treating physician)
  • Measurable disease by computed tomography (CT), magnetic resonance imaging (MRI), and/or positron emission tomography (PET) with at least one target lesion measuring 1.5 cm or larger
  • Patients must be considered ineligible for rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone (R-CHOP) standard therapy; to be ineligible for R-CHOP, patients must meet at least one of the following criteria are met:
  • Prior anthracycline therapy for other malignancies or other disorders whereby if additional anthracyclines are given for DLBCL, the maximum lifetime allowable dose will be exceeded
  • Meeting the geriatric criteria of ineligibility for standard R-CHOP if one of the following criteria is present:
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  • Three or more organ systems with a score of 3 or any 1 organ system with a score of 4 (using the Cumulative Illness Rating Scale for Geriatrics, [CIRS-G])
  • Score of 3 or above on the Vulnerable Elders Survey (VES-13)
  • Score of =< 9 in the short physical performance battery (SPPB)
  • Presence of a significant geriatric syndrome (dementia, delirium, falls, incontinence, malnutrition, and severe osteoporosis) in the past year prior to diagnosis
  • Any abnormality in performing activities of daily living (ADLs) or instrumental activities of daily living (IADLs)
  • Absolute neutrophil count (ANC) >= 1.5 unless cytopenias are related to bone marrow involvement with disease
  • Hemoglobin >= 7 g/dl unless cytopenias are related to bone marrow involvement with disease
  • Platelets >= 75,000 unless cytopenias are related to bone marrow involvement with disease
  • Glomerular filtration rate (GFR) > 30 using Cockcroft-Gault formula
  • Total bilirubin =< 3 times the upper limit of normal unless hepatic dysfunction is related to liver involvement with disease
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 5.0 times the upper limit of normal unless hepatic dysfunction is related to liver involvement with disease
  • Alkaline phosphatase =< 5.0 times the upper limit of normal unless hepatic dysfunction is related to liver involvement with disease
  • The ability to understand and sign a written informed consent

Who cannot join

  • Prior therapy for DLBCL
  • Other non-Hodgkin lymphoma (NHL) histologies
  • Known central nervous system (CNS) involvement
  • Known human immunodeficiency virus (HIV) or human T-lymphotropic virus, type I (HTLV-I) positive status
  • Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver involvement with NHL or stable chronic liver disease per treating investigator assessment)
  • Treatment with any known non-marketed drug substance or experimental therapy within 4 weeks prior to enrollment, or currently participating in any other interventional clinical study for NHL or any other illness (except observational and registry trials)
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  • Other past or current malignancy; subjects who have been free of malignancy for at least 3 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma (any site) are eligible; women with a history of cervical cancers are allowed
  • Chronic or current infectious disease requiring systemic antibiotics, antifungal (excluding antifungals given for nail-beds infections), or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis C
  • History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
  • Positive hepatitis serology:
  • Hepatitis B virus (HBV): patients with positive serology for hepatitis B defined as positivity for hepatitis B surface antigen (HBsAg) or anti-hepatitis B core antibody (HBc); patients who are positive for anti-HBc may be considered for inclusion in the study on a case-by-case basis if they are hepatitis B viral deoxyribonucleic acid (DNA) negative and are willing to undergo ongoing HBV DNA testing by real-time polymerase chain reaction (PCR); patients with positive serology may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management
  • Hepatitis C (hepatitis C virus [HCV]): patients with positive hepatitis C serology unless HCV ribonucleic acid (RNA) is confirmed negative and may be considered for inclusion in the study on a case-by-case basis
  • Positive serology for hepatitis C (HC) defined as a positive test for hepatitis C antibody (HCAb)
  • Inability to comply with study or follow-up testing and procedures
  • Prior radiotherapy is allowed if it was given for low-grade lymphoma before transformation in those with transformed NHL and as long as no chemotherapy was administered in conjunction with radiation
  • Any patient receiving a live vaccine must allow a 4-week interval before starting treatment on this study
  • Known hypersensitivity to mannitol
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or a known hypersensitivity to any of the other study drugs
  • Major surgery within 4 weeks from cycle # 1
  • Fertile men or women of childbearing potential unless 1) surgically sterile or 2) using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly
  • Effective contraception is required while receiving obinutuzumab; for women, effective contraception is required to continue for >= 12 months after the last dose of obinutuzumab; for men, effective contraception is required to continue for 3 months after the last dose of obinutuzumab treatment
  • Vaccination with a live vaccine a minimum of 28 days prior to the start of treatment

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: Multicenter Phase II Study of the Bendamustine, Obinutuzumab, and Dexamethasone (BOD) Regimen in Un-fit Elderly ≥ 70 Years of Age Diffuse Large B-Cell Non-Hodgkin Lymphoma (DLBCL) Patients

This phase II trial studies how well bendamustine hydrochloride, obinutuzumab, and dexamethasone work in treating older patients with diffuse large B-cell lymphoma. Drugs used in chemotherapy, such as bendamustine hydrochloride and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as obinutuzumab, may find cancer cells and help kill them. Giving bendamustine hydrochloride, obinutuzumab, and dexamethasone may kill more cancer cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Assess the overall response rate (ORR; complete responders [CR] + partial responders [PR]) using the Cheson et al parameters of this novel combination regimen.

SECONDARY OBJECTIVES:

  1. Assess the feasibility of incorporating prospective geriatric assessments in patients >= 70 years of age diagnosed with diffuse large B-cell lymphoma (DLBCL) and treated in a multi-center setting.

II. Quality of life (QOL) based on Functional Assessment of Cancer Therapy-Lung (FACT-L) scale on all enrolled patients.

III. Progression-free survival (PFS) at 2 and 3 years. IV. Overall survival (OS) at 2 and 3 years.

OUTLINE:

Patients receive bendamustine hydrochloride intravenously (IV) over 30 minutes on days 1 and 2, obinutuzumab IV over 4 hours on days 1 or 2, 8, and 15 (on both days 1 and 2 in course 1 only), dexamethasone orally (PO) daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 40 months.

Being tested
Bendamustine Hydrochloride, Obinutuzumab, Dexamethasone, Quality-of-Life Assessment, Laboratory Biomarker Analysis
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • Bendamustine HydrochlorideDrug

    Also called Ribomustin, SyB L-0501, Treanda

    Given IV

  • ObinutuzumabBiological

    Also called Anti-CD20 Monoclonal Antibody R7159, GA101, Gazyva, R7159

    Given IV

  • DexamethasoneDrug

    Also called DM

    Given PO

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT02420210
Study groupRoleWhat they receive
Treatment (bendamustine, obinutuzumab, dexamethasone)ExperimentalPatients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2, obinutuzumab IV over 4 hours on days 1 or 2, 8, and 15 (on both days 1 and 2 in course 1 only), dexamethasone PO daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Bendamustine Hydrochloride; Biological: Obinutuzumab; Drug: Dexamethasone; Other: Quality-of-Life Assessment; Other: Laboratory Biomarker Analysis

What is being measured

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

  1. ORR (PR + CR) Using the Cheson et al Parameters

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

    Measured: Up to 8 months

Secondary outcomes (5)

  1. Feasibility, Defined as Completing All Required Geriatric Assessments Where Applicable Per the Protocol in 80% or More of the Enrolled Eligible Patients

    Measured: Up to 40 months

  2. Overall Survival

    Survival analyses will be performed according to Kaplan and Meier methods. Prognostic factors that predict favorable outcomes and responses will be evaluated in both univariate and multivariate analyses using Cox proportional hazards regression for possible indicator of better OS. OS will also be stratified for bulky versus non-bulky disease comparisons (defined as any site with more than 5 cm in largest diameter).

    Measured: From date of study entry (date of first treatment) until death from any cause, assessed at 2 years

  3. Overall Survival (OS)

    Survival analyses will be performed according to Kaplan and Meier methods. Prognostic factors that predict favorable outcomes and responses will be evaluated in both univariate and multivariate analyses using Cox proportional hazards regression for possible indicator of better OS. OS will also be stratified for bulky versus non-bulky disease comparisons (defined as any site with more than 5 cm in largest diameter).

    Measured: From date of study entry (date of first treatment) until death from any cause, assessed at 3 years

  4. Progression Free Survival

    Kaplan-Meier analysis will be performed. Prognostic factors that predict favorable outcomes and responses will be evaluated in both univariate and multivariate analyses using Cox proportional hazards regression for possible indicator of better PFS.

    Measured: From date of study entry (date of first treatment) until progression, secondary malignancy, or death from any cause, assessed at 2 years

  5. Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

    Adverse events will be tabulated by type and grade.

    Measured: Up to 30 days following the last administration of study treatment

Timeline

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

  1. First posted17 Apr 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionAug 2016
  4. Study completionAug 2016

Why it stopped: Trials was stopped early due to lack of funding.

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
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02420210
Sponsor's protocol ID
IRB14-1120
Other IDs
NCI-2015-00355, IRB14-1120, P30CA014599
Status last verified
May 2018
First submitted
14 Apr 2015
Last updated
6 Jun 2018
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bendamustine Hydrochloride, Obinutuzumab and Dexamethasone in people with Diffuse Large B-Cell Lymphoma, run by University of Chicago at 1 site 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?

The sponsor lists 19 inclusion and 22 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: stopped early, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 14 Mar 2018). 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?

ORR (PR + CR) Using the Cheson et al Parameters (time frame: Up to 8 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 NCT02420210.

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 Jun 2018.

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