AzTrials
AzTrials

Diffuse Large B-Cell LymphomaPhase 2NCT01234467

Bendamustine + Rituximab in Older Patients With Previously Untreated Diffuse Large B-cell Lymphoma

A Phase 2 study testing Bendamustine and Rituximab in people with Diffuse Large B-Cell Lymphoma and Lymphoma, Diffuse Large-Cell, run by UNC Lineberger Comprehensive Cancer Center at 7 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

The purpose of this research study is to learn about the safety of the treatment with a combination of bendamustine and rituximab and to find out what effects, both good and bad this treatment has on DLBCL. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Bendamustine and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
7 sitesUnited States
Study dates
Mar 2011to 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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patients with previously untreated , histologically confirmed, diffuse large B-cell lymphoma (DLBCL), immunophenotyped for CD20
  • Age greater than or equal to 65 years
  • Stage II-IV
  • Measurable disease including lesions that can be accurately measured in 2 dimensions by CT and have a greatest transverse diameter of 1cm or greater, and/or by bone marrow histopathology.
  • ECOG performance status of 0-3
  • Deemed poor candidate for CHOP-R due to ejection fraction less than or equal to 45%, ECOG performance status of 2, or in the opinion of the treating physician, patient would not tolerate administration of CHOP-R chemotherapy for other reasons,
Show all 18Show fewer
  • Life expectancy of at least 3 months;
  • Documented negative serologic testing for HIV, Hepatitis B (unless positive due to prior vaccination), and hepatitis C within the year prior to enrollment
  • Adequate bone marrow function (without transfusion support within one week of screening) function:
  • Hemoglobin > 8 g/dL
  • Absolute neutrophil count (ANC) >1000 cells/mm3
  • Platelet count > 75,000/mm3
  • Adequate hepatic and renal function as demonstrated by:
  • Aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN)
  • Total serum bilirubin < 2.5 x ULN
  • Serum creatinine < 1.5 x ULN
  • If sexually active male of reproductive capability, has agreed to use a medically accepted form of contraception from time of enrollment to completion of all follow-up study visits
  • Signed an institutional review board (IRB) approved informed consent document

Who cannot join

  • Central nervous system involvement by lymphoma
  • History of previous allergic reactions to compounds of similar biological or chemical composition as rituximab or bendamustine
  • Medical or other condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objective.
  • Other active malignancies (except: non-melanoma skin cancer, cervical carcinoma in situ without evidence of disease, prostatic intraepithelial neoplasia without evidence of prostate cancer)
  • Patients on strong inhibitors of CYP1A2.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Seby B. Jones Cancer Center

    Boone, North Carolina, 28607

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Northeast Medical Center

    Concord, North Carolina, 28025

  • Moses Cone Regional Cancer Center

    Greensboro, North Carolina, 27403

  • Leo Jenkins Cancer Center, East Carolina University Medical Center

    Greenville, North Carolina, 27834

  • Rex Healthcare

    Raleigh, North Carolina, 27607

  • Marion L. Shepard Cancer Center

    Washington, North Carolina, 27889

Other trials in United States

About this study

Official title: A Phase II Trial of Bendamustine in Combination With Rituximab in Older Patients With Previously Untreated Diffuse Large B-cell Lymphoma

The purpose of this research study is to learn about the safety of the treatment with a combination of bendamustine and rituximab and to find out what effects, both good and bad this treatment has on DLBCL. In addition to learning about the combination of bendamustine and rituximab, the researchers are interested in learning about how this cancer treatment affects daily activities. Subjects will be asked to complete a Geriatric Assessment (GA). GAs are designed to gather information on memory, nutritional status, mental health, and level of social support. GAs are also designed to help the health care team understand how well subjects can carry out their day to day activities and to briefly describe what other medical conditions subjects may have. This assessment will help the health care team understand a subject's "functional age" (the age a subject functions at) as compared to a subject's actual age.

The researchers also want to learn how chemotherapy affects the aging process in our bodies. This is done by measuring the amount of p16 in blood. Researchers want to understand if chemotherapy changes the levels of p16 in blood.

Read the detailed description

This multicenter Phase II clinical study will investigate the complete response (CR) rate after therapy with bendamustine combined with rituximab in older (≥65 years old) patients with previously untreated stage II-IV DLBCL deemed poor candidates for cyclophosphamide, doxorubicin hydrochloride, vincristine (Oncovin®), prednisone, rituximab (CHOP-R); n=37. The hypothesis being tested is that this regimen will be safe and effective as frontline therapy in older DLBCL patients deemed poor candidates for CHOP-R. After 3 cycles of therapy, patients with less than a partial response (PR) will come off study, and be managed at the discretion of their treating physician. Patients who achieve a PR after 3 cycles will continue for a total of 8 cycles of therapy, while patients who achieve a CR will continue for a total of 6 cycles of therapy. Secondary objectives include overall response rates (ORR), disease-free, progression-free and overall survival, and an evaluation of the toxicity and tolerability of the regimen.

This trial also includes an exploratory analysis designed to evaluate a potential correlation between expression of the senescence marker p16INK4a and the toxicity associated with this regimen.

In addition, patients will be asked to participate in a Geriatric Assessment (GA) tool during the trial.

Being tested
Bendamustine, Rituximab
Keywords
Diffuse Large B-Cell Lymphoma, Elderly, Newly Diagnosed, Lineberger Comprehensive Cancer Center, University of North Carolina, Bendamustine, Rituximab, Rituxan, Treanda, Phase 2, Geriatric, Lymphoma
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma

What participants receive

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

  • BendamustineDrug

    Also called TREANDA, BENDAMUSTINE HYDROCHLORIDE, (NDA) 022249

    Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles

  • RituximabDrug

    Also called Rituxan, (BLA) 103705

    Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles

Study groups in NCT01234467
Study groupRoleWhat they receive
Bendamustine, RituximabExperimentalThis is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.
Receives: Drug: Bendamustine; Drug: Rituximab

What is being measured

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

  1. Complete Response (CR) Rate as Defined by The International Harmonization Project for Response Criteria

    Complete response (CR) is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. The complete response rate is the percentage of participants achieving a CR.

    Measured: 2 years

Secondary outcomes (5)

  1. Overall Response Rate (ORR)

    The ORR consists of the complete response rate + the partial response rate (percentage of participants achieving a complete or partial response). Complete response is defined by The International Harmonization Project for Response Criteria as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Partial response is defined as regression of measurable disease and no new sites.

    Measured: 2 years

  2. Partial Response Rate

    The percentage of participants achieving a partial response (PR). PR is defined by The International Harmonization Project for Response Criteria as regression of measurable disease and no new sites.

    Measured: 2 years

  3. Estimate of Progression-Free Survival

    Progression-free survival (PFS) will be summarized using the Kaplan-Meier method. PFS was defined as the time from the start of treatment until lymphoma progression or death as a result of any cause. Progression was defined by The International Harmonization Project for Response Criteria as any new lesion or increase by ≥50% of previously involved sites from nadir.

    Measured: 2 years with the median follow-up of 29 months

  4. Overall Survival

    This represents the Kaplan-Meier estimates of median overall survival defined as the time from start of treatment until death as a result of any cause.

    Measured: 2 years with the median follow-up of 29 months

  5. Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab

    The major grade 3 or higher adverse events were haematological toxicities. The results below include common haematological and non-haematological toxicities of grade 3 or higher. A complete record of all adverse events are reported in the adverse events section. National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0 were used to assess toxicity.

    Measured: Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.

Timeline

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

  1. First posted4 Nov 2010 (estimated)
  2. Study startMar 2011
  3. Primary completionDec 2013
  4. Study completionAug 2016

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
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01234467
Sponsor's protocol ID
LCCC 1011
Other IDs
10-1405
Status last verified
Apr 2017
First submitted
2 Nov 2010
Last updated
24 May 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bendamustine and Rituximab in people with Diffuse Large B-Cell Lymphoma and Lymphoma, Diffuse Large-Cell, run by UNC Lineberger Comprehensive Cancer Center at 7 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?

The sponsor lists 18 inclusion and 5 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 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 26 Apr 2017). 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?

Complete Response (CR) Rate as Defined by The International Harmonization Project for Response Criteria (time frame: 2 years). 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 NCT01234467.

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 24 May 2017.

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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in