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LymphomaPhase 2NCT01029730

Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma

A Phase 2 study testing Bendamustine, Bortezomib and Rituximab in people with Lymphoma, run by SCRI Development Innovations, LLC at 20 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 goal of this multi-center Phase II study is to add bortezomib to the highly active regimen of bendamustine and rituximab. In this study, bortezomib will be administered on a weekly schedule (Days 1, 8, 15) and will be added to bendamustine/rituximab given in 4-week cycles. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
Bendamustine, Bortezomib and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
20 sitesUnited States
Study dates
Mar 2010to Jul 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically-confirmed indolent lymphoma by the World Health Organization (WHO) classification. The biopsy must fulfill one of the following criteria:
  • Follicular lymphoma, grade 1 or 2
  • Marginal zone lymphoma
  • Small lymphocytic lymphoma (circulating lymphocyte count must be <5,000)
  • Lymphoplasmacytic lymphoma
  • At least one of the following criteria must be met:
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  • Presence of any symptoms related to lymphoma. These can include classic B-symptoms (fever [>38°C] of unclear etiology, night sweats, weight loss of greater than 10% within the prior 6 months) or other lymphoma-related symptoms (fatigue, pain, etc.).
  • Large tumor mass (bulky disease) characterized by lymphomas with a diameter of more than 3 cm in three or more regions or by a lymphoma with a diameter >7 cm in one region
  • Presence of lymphoma-related complications, including narrowing of ureters or bile ducts, tumor-related compression of a vital organ, lymphoma-induced pain, cytopenias related to lymphoma/leukemia, splenomegaly, pleural effusions, or ascites
  • Hyperviscosity syndrome due to monoclonal gammopathy
  • The lymph node biopsy or other lymphoma pathology specimen has CD20+ B-cells.
  • Ann-Arbor Stage 2 (non-contiguous), 3, or 4 disease.
  • No previous systemic treatment for lymphoma. Patients may have had a single course of radiation therapy to a limited field (i.e., not exceeding two adjacent lymph node regions).
  • The patient has bidimensionally measurable disease with at least 1 lesion measuring ≥2.0 cm in a single dimension, and the field was not previously radiated.
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
  • Adequate hematologic function ≤7 days prior to start of study treatment:
  • Hemoglobin ≥10.0 g/dl
  • Absolute neutrophil count (ANC) ≥1000/µL
  • Platelet count ≥75,000/µL. If low counts are attributable to bone marrow infiltration or hypersplenism due to lymphoma, ANC must be ≥750/µL and platelets ≥50,000/µL.
  • Calculated or measured creatinine clearance ≥30 mL/min ≤7 days of study enrollment (using Cockcroft-Gault method).
  • Adequate hepatic function (≤2.5 x upper limit of normal [ULN] for alanine aminotransferase [ALT], aspartate aminotransferase [AST], and alkaline phosphatase and total bilirubin within normal limits).
  • Patients must be ≥18 years of age.
  • Women of childbearing potential must agree to use a medically acceptable method of birth control (e.g., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and for 12 months after their last dose of rituximab. Men must use an acceptable method/form of contraception for the duration of treatment and for 3 months after the end of treatment.
  • Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.

Who cannot join

  • The patient has chronic lymphocytic leukemia.
  • The patient has transformed lymphoma.
  • History of, or clinically apparent, central nervous system (CNS) lymphoma or leptomeningeal lymphoma.
  • The patient has received corticosteroids for treatment of lymphoma. Chronic, low-dose corticosteroids (e.g., prednisone ≤20 mg/day) are allowed for treatment uses other than lymphoma or complications of lymphoma.
  • Peripheral neuropathy ≥ CTCAE v3.0 grade 2, ≤14 days of study enrollment.
  • Myocardial infarction ≤6 months prior to study enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, ECG abnormalities at screening must be documented as not medically relevant.
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  • History of solid organ transplantation, or post-transplant lymphoproliferative disorder.
  • Patients with known history of hepatitis B or hepatitis C infection. Hepatitis B surface antigen must be tested.
  • The patient has known human immunodeficiency virus (HIV) infection.
  • Active, clinically serious infection > grade 2. Patients may be eligible upon resolution of the infection.
  • Female patient is pregnant or breast-feeding. Confirmation that female patients of childbearing potential are not pregnant must be established by a negative serum pregnancy test ≤7 days prior to the start of treatment.
  • Known hypersensitivity to bendamustine, bortezomib, boron, mannitol, or rituximab.
  • Concomitant active malignancy requiring therapy.
  • Diagnosis or treatment for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
  • Treatment with other investigational agents ≤14 days prior to study enrollment.
  • Any other disease(s), psychiatric condition, metabolic dysfunction, or findings from a physical examination or clinical laboratory test result that would cause reasonable suspicion of a disease or condition, that contraindicates the use of study drugs, that may increase the risk associated with study participation, that may affect the interpretation of the results, or that would make the patient inappropriate for this study.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Hematology Oncology Clinic, LLP

    Baton Rouge, Louisiana, 70806

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • National Capital Clinical Research Consortium

    Bethesda, Maryland, 20817

  • Chattanooga Oncology Hematology Associates

    Chattanooga, Tennessee, 37404

  • St. Louis Cancer Care

    Chesterfield, Missouri, 63017

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Florida Cancer Specialists

    Fort Myers, Florida, 33916

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • NEA Baptist Clinic

    Jonesboro, Arkansas, 72401

  • Cancer Centers of Southwest Oklahoma

    Lawton, Oklahoma, 73505

  • Baptist Hospital East

    Louisville, Kentucky, 40207

  • Hematology-Oncology Associates of Northern NJ

    Morristown, New Jersey, 07960

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37023

  • Portsmouth Regional Hospital

    Portsmouth, New Hampshire, 03801

  • Hematology Oncology of the North Shore

    Skokie, Illinois, 60076

  • Providence Medical Group

    Terre Haute, Indiana, 47802

  • Schiffler Cancer Center

    Wheeling, West Virginia, 26003

Other trials in United States

About this study

Official title: Phase II Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma

The goal of this multi-center Phase II study is to add bortezomib to the highly active regimen of bendamustine and rituximab. In this study, bortezomib will be administered on a weekly schedule (Days 1, 8, 15) and will be added to bendamustine/rituximab given in 4-week cycles. This combination uses the standard bendamustine dosing schedule, and is more convenient than the 5-week regimen of these 3 drugs currently being studied.

Conditions
Lymphoma
Keywords
Low grade lymphoma, Previously untreated lymphoma, Lymphoma first line, bendamustine, Treanda, bortezomib, Velcade, rituximab, Rituxan
Medical subject headings
Lymphoma, Lymphoma, Non-Hodgkin

What participants receive

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

  • BendamustineDrug

    Also called TREANDA®

    Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles

  • BortezomibDrug

    Also called VELCADE®

    Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles

  • RituximabDrug

    Also called Rituxan®

    Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1

Study groups in NCT01029730
Study groupRoleWhat they receive
Bendamustine/Bortezomib/RituximabExperimentalTreatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.
Receives: Drug: Bendamustine; Drug: Bortezomib; Drug: Rituximab

What is being measured

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

  1. Complete Response Rate

    Percentage of patients experiencing a complete response (CR) per RECIST. CR = disappearance of all target lesions.

    Measured: 18 months

Secondary outcomes (3)

  1. Overall Response Rate

    The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: 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: At 3 and 6 months during treatment, then 6 months post-treatment.

  2. Median Progression-free Survival

    The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: at 3 and 6 months, then every 3 months post-treatment for 1 year and every 6 months thereafter until disease progression; projected 2 years.

  3. Number of Participants With Adverse Events as a Measure of Safety.

    Toxicity grades will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. Includes adverse events occurring in >1 patient

    Measured: Days 1,8, and 15 of each 28-day cycle for 6 months, then every 3 months for a year, projected 2 years.

Timeline

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

  1. First posted10 Dec 2009 (estimated)
  2. Study startMar 2010
  3. Primary completionOct 2014
  4. Study completionJul 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
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01029730
Sponsor's protocol ID
SCRI LYM 66
Status last verified
Jul 2016
First submitted
8 Dec 2009
Last updated
19 Aug 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bendamustine, Bortezomib and Rituximab in people with Lymphoma, run by SCRI Development Innovations, LLC at 20 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 24 inclusion and 16 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 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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 28 Dec 2015). 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 Rate (time frame: 18 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 NCT01029730.

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 Aug 2016.

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