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Diffuse Large B-Cell LymphomaPhase 2904NCT00831597

Bendamustine Combined With Rituximab for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

A Phase 2 study testing bendamustine and rituximab in people with Diffuse Large B-Cell Lymphoma, run by Pharmatech at 33 sites in United States.

Completed

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

Official record
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Trial summary

A phase II trial to evaluate the efficacy and safety of combination bendamustine and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma. It is hypothesized that the BR combination will produce at least a 70% overall response rate. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B-Cell Lymphoma
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
61 participants
Where
33 sitesUnited States
Study dates
Nov 2008to Sep 2013
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Histologically confirmed CD20-positive, diffuse large B-cell lymphoma
  • Measurable disease with at least one bidimensional lymph node or tumor mass > 1.5 cm in the longest diameter that can be followed for response as a target lesion as measured by PET or CT
  • Relapsed or refractory after at least one prior therapeutic treatment for diffuse large B-cell lymphoma. Relapsed is defined as patients who initially responded and then progressed. Refractory is defined as patients, whom in the judgment of the Investigator, received adequate prior treatment and did not respond during treatment or progressed within 60 days of last treatment. Relapse following an autologous stem cell transplant allowed.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
  • Patient must understand and voluntarily sign IRB-approved informed consent
  • Life expectancy ≥ three (3) months
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  • Age ≥ 18 years old
  • Laboratory parameters:
  • Absolute neutrophil count ≥ 1,000 cells/mm(3)
  • Platelet count ≥ 75,000 cells/mm(3)
  • Hemoglobin ≥ 8 g/dL
  • Creatinine ≤ 2.0 mg/dL or Creatinine Clearance ≥ 50 mL/min (calculated or 24-hr urine sample)
  • AST/SGOT 2.0 x ULN (≤ 5.0 x ULN if secondary to liver metastases)
  • ALT/SGPT 2.0 x ULN (≤ 5.0 x ULN if secondary to liver metastases)
  • Total bilirubin ≤ 2.0 x ULN

Who cannot join

  • Patients with active/symptomatic central nervous system (CNS) involvement based on clinical evaluation. Previously treated CNS involvement that has remained asymptomatic for ≥ 90 days allowed if no CNS involvement shown by lumbar puncture, PET, CT or MRI.
  • Prior treatment with bendamustine
  • Known sensitivity to bendamustine or any component of bendamustine
  • Known anaphylaxis or immunoglobulin E (IgE) mediated hypersensitivity to murine proteins or sensitivity to rituximab or any component of rituximab
  • Eligible for stem cell transplant (patients who refuse procedure will not be excluded)
  • Prior allogeneic stem cell transplant within 6 months of Cycle 1, Day 1
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  • Major surgery, not related to debulking procedures, within 21 days of Cycle 1, Day 1. Patients undergoing debulking procedures and minor surgery are allowed after a recovery period, in the judgment of the Investigator.
  • Chemotherapy, immunotherapy, or irradiation within 28 days of Cycle 1, Day 1 (within 6 weeks for nitrosoureas or mitomycin). Patients on high dose corticosteroids must have tapered to a stable dose equivalent to Prednisone ≤ 15 mg per day within 28 days of Cycle 1, Day 1.
  • Prior radioimmunotherapy (i.e. Zevalin®) within 10 weeks of Cycle 1, Day 1
  • Prior use of investigational anti-cancer agents within 28 days of Cycle 1, Day 1
  • Unresolved toxicities ≥ grade 2 from previous therapy
  • Pregnant or lactating females. Females of childbearing potential (FCBP) and non-vasectomized men must agree to use effective methods of birth control during and 28 days following treatment period. FCBP must have a negative pregnancy test.
  • HIV-related lymphoma
  • Known active HIV or HCV infection, or known seropositivity for HIV, or current or chronic HBV or HCV infection. HBV test required at screening or within 6 months of screening and must indicate negative result. Patients with seropositivity presumed to be due to prior vaccination against Hepatitis B or resolved infection are not excluded (see HBV reactivation guidelines included in rituximab prescribing information).
  • Concurrent active or history of other malignancies, except nonmelanoma skin cancer or carcinoma in situ of cervix or breast. Patients with previous malignancies are eligible provided they have been disease free for ≥ 1 year.
  • Serious (grade 3-4), active, intercurrent infection requiring therapy, or deep seated or systemic mycotic infections
  • Myocardial infarction within 6 months prior to registration or New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or significant conduction system abnormalities, in the judgment of the Investigator
  • Thyroid disease in which thyroid function cannot be maintained within normal range, in the judgment of the Investigator
  • Concurrent uncontrolled serious medical or psychiatric conditions likely to interfere with participation in this clinical study, in the judgment of the Investigator

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

United States33 sites

  • Pharmatech Oncology Study Site

    Akron, Ohio, 44304

  • Pharmatech Oncology Study Site

    Austin, Texas, 78759

  • Pharmatech Oncology Study Site

    Bay Shore, New York, 11706

  • Pharmatech Oncology Study Site

    Bethlehem, Pennsylvania, 18015

  • Pharmatech Oncology Study Site

    Beverly Hills, California, 90211

  • Pharmatech Oncology Study Site

    Boynton Beach, Florida, 33435

  • Pharmatech Oncology Study Site

    Brooksville, Florida, 34613

  • Pharmatech Oncology Study Site

    Cherry Hill, New Jersey, 08003

  • Pharmatech Oncology Study Site

    Chesterfield, Missouri, 63017

  • Pharmatech Oncology Study Site

    Columbus, Ohio, 43219

  • Pharmatech Oncology Study Site

    Corpus Christi, Texas, 78463

  • Pharmatech Oncology Study Site

    Dubuque, Iowa, 52001

  • Pharmatech Oncology Study Site

    East Setauket, New York, 11733

  • Pharmatech Oncology Study Site

    Fort Worth, Texas, 76104

  • Pharmatech Oncology Study Site

    Fountain Valley, California, 92708

  • Pharmatech Oncology Study Site

    Gainesville, Florida, 32605

  • Pharmatech Oncology Study Site

    Germantown, Tennessee, 38138

  • Pharmatech Oncology Study Site

    Gettysburg, Pennsylvania, 17325

  • Pharmatech Oncology Study Site

    Hilton Head, South Carolina, 29926

  • Pharmatech Oncology Study Site

    Jackson, Mississippi, 39202

  • Pharmatech Oncology Study Site

    Joliet, Illinois, 60435

  • Pharmatech Oncology Study Site

    Lafayette, Indiana, 47904

  • Pharmatech Oncology Study Site

    Lubbock, Texas, 79410

  • Pharmatech Oncology Study Site

    Muncie, Indiana, 47303

  • Pharmatech Oncology Study Site

    Oxnard, California, 93030

  • Pharmatech Oncology Study Site

    Paducah, Kentucky, 42001

  • Pharmatech Oncology Study Site

    Phillipsburg, New Jersey, 08865

  • Pharmatech Oncology Study Site

    Richardson, Texas, 75080

  • Pharmatech Oncology Study Site

    The Bronx, New York, 10467

  • Pharmatech Oncology Study Site

    Titusville, Florida, 32796

  • Pharmatech Oncology Study Site

    Washington D.C., District of Columbia, 20037

  • Pharmatech Oncology Study Site

    Washington D.C., District of Columbia, 20422

  • Pharmatech Oncology Study Site

    York Village, Maine, 03909

Other trials in United States

About this study

A phase II trial to evaluate the efficacy and safety of combination bendamustine and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma. It is hypothesized that the BR combination will produce at least a 70% overall response rate.

Being tested
bendamustine, rituximab
Keywords
Lymphoma, B-Cell
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

    120 mg/m2 IV, Days 1, 2 of Cycles 1-6

  • rituximabDrug

    Also called Rituxan

    375 mg/m2 IV, Day 1 of Cycles 1-6

Study groups in NCT00831597
Study groupRoleWhat they receive
Bendamustine with rituximabExperimentalAll patients received combination bendamustine with rituximab
Receives: Drug: bendamustine; Drug: rituximab

What is being measured

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

  1. Best Overall Response Rate (ORR) of bendamustine in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma

    Measured: 1 year for 1st assessment and then 2.5 years for final assessment

Secondary outcomes (5)

  1. Duration of Response (DOR)

    Measured: 1 year for 1st assessment and then 2.5 years for final assessment

  2. Time to Progression (TTP)

    Measured: 1 year for 1st assessment and then 2.5 years for final assessment

  3. Progression-Free Survival (PFS)

    Measured: 1 year for 1st assessment and then 2.5 years for final assessment

  4. Safety Profile of Study Treatment

    Measured: 1 year for 1st assessment and then 2.5 years for final assessment

  5. Overall Survival (OS)

    Measured: 1 year for 1st assessment and then 2.5 years for final assessment

Timeline

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

  1. First posted29 Jan 2009 (estimated)
  2. Study startNov 2008
  3. Primary completionAug 2013
  4. Study completionSep 2013

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
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00831597
Sponsor's protocol ID
PI-08904
Other IDs
IND Exemption Number 103985
Acronym
904
Status last verified
May 2012
First submitted
26 Jan 2009
Last updated
19 Apr 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Vacirca JL, Acs PI, Tabbara IA, Rosen PJ, Lee P, Lynam E. Bendamustine combined with rituximab for patients with relapsed or refractory diffuse large B cell lymphoma. Ann Hematol. 2014 Mar;93(3):403-9. doi: 10.1007/s00277-013-1879-x. Epub 2013 Aug 17.

    PubMed 23955074

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, run by Pharmatech at 33 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 15 inclusion and 19 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 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Best Overall Response Rate (ORR) of bendamustine in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (time frame: 1 year for 1st assessment and then 2.5 years for final assessment). 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 NCT00831597, 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 19 Apr 2016.

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