Pilot Study of Bortezomib, Bendamustine and Rituximab on Non-Hodgkin's Lymphoma (BVR)

This study has been completed.
Sponsor:
Collaborators:
Millennium Pharmaceuticals, Inc.
Cephalon
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00547534
First received: October 18, 2007
Last updated: November 10, 2011
Last verified: November 2011
  Purpose

The purpose of this study is to evaluate how non-Hodgkin's lymphoma that has not responded to, or that has returned after standard treatment, responds to bortezomib, rituximab and bendamustine, and also to see what effects this drug combination have on this cancer.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: bortezomib
Drug: bendamustine
Drug: rituximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Bortezomib, Bendamustine and Rituximab for Patients With Relapsed or Refractory, Indolent or Mantle Cell Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Number of Participants With Progression Free Survival at 2 Years [ Time Frame: Two years ] [ Designated as safety issue: No ]
    To determine the progression-free survival following treatment with the BVR combination in patients with relapsed or refractory indolent and mantle cell non-Hodgkin lymphoma.


Secondary Outcome Measures:
  • Toxicity of Drug Combination in the Subjects [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
  • Overall Response Rate (ORR) [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Overall response rate (ORR)to protocol treatment - Partial response, Complete response, etc.


Enrollment: 31
Study Start Date: October 2007
Study Completion Date: October 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lymphoma Subjects receiving protocol therapy
Subjects that met all eligibility criteria and were treated with Bendamustine, Rituxan and Bortezomib.
Drug: bortezomib
1.3 mg/m^2 on days 1, 4, 8, 11
Other Name: Velcade
Drug: bendamustine
90 mg/m^2 days 1 and 4
Other Name: Treanda
Drug: rituximab
375 mg/m^2 day 1
Other Name: Rituxan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Voluntary written informed consent before performance of any study-specific procedure not part of routine medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  • Female subject is either post-menopausal or surgically sterilized or willing to use acceptable method of birth control for duration of study.
  • Male subject agrees to use acceptable method for contraception for duration of study.
  • Histologically-confirmed indolent or mantle cell lymphoma, utilizing the World Health Organization (WHO) classification. The biopsy must fulfill one of the following criteria:

    • Follicular lymphoma, grades 1-3
    • Marginal zone lymphoma
    • Small lymphocytic lymphoma (circulating lymphocyte count must be < 5,000)
    • Lymphoplasmacytic lymphoma
    • Mantle cell lymphoma [confirmed by cyclin D1+ or FISH for t(11;14)]
  • Age ≥ 18 years
  • Must have received at least one prior chemotherapy regimen for lymphoma. Patients treated only with antibody therapy or only with radiation therapy are not eligible.
  • Zubrod performance status ≤ 3
  • Patients must have measurable disease or an indication to receive additional therapy

Exclusion Criteria:

  • Patient has platelet count of ≤75,000/mm^3 within 14 days before enrollment.
  • Patient has absolute neutrophil count of < 1,000/mm^3 within 14 days before enrollment.
  • Patient has calculated or measured creatinine clearance of <30 mL/minute within 14 days before enrollment.
  • Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment.
  • Myocardial infarction within 6 months prior to enrollment or has New York Heart Association 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, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
  • Patient has hypersensitivity to boron or mannitol
  • Female subject is pregnant or breast-feeding. Confirmation subject is not pregnant must be established by negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
  • Patient has received chemotherapy or antibody therapy within 28 days before enrollment
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  • Patient has received other investigational drugs with 14 days before enrollment
  • Diagnosed or treated 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.
  • Prior exposure to bendamustine
  • Prior exposure to bortezomib if Time to Progression (TTP) after bortezomib containing regimen was < 6 months. If TTP after bortezomib containing regimen was > 6 months, then patient is allowed to enroll on the study.
  • Patient has concomitant active malignancy requiring therapy
  • Patient is known to be HIV positive (test result not required for enrollment).
  • History of solid organ transplantation, or post transplant lymphoproliferative disorder
  • Patient has history of allogeneic stem cell transplantation.
  • Patient has history of autologous stem cell transplantation or radioimmunotherapy within the previous 4 months.
  • Patient has received any other investigational drugs within 14 days prior to enrollment
  • History of, or clinically apparent CNS lymphoma
  • Any clinically significant abnormality in screening blood chemistry, hematology, or urinalysis results that, in the judgment of the investigator, would impede adequate evaluation of adverse events and/or response to treatment, or that requires aggressive intervention
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547534

Locations
United States, Nebraska
Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New York
Cornell Wiell Medical College
New York, New York, United States, 10021
University of Rochester Medical Center (James P. Wilmot Cancer Center)
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Millennium Pharmaceuticals, Inc.
Cephalon
Investigators
Principal Investigator: Jonathan Friedberg, md University of Rochester
  More Information

No publications provided by University of Rochester

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT00547534     History of Changes
Other Study ID Numbers: ULYM07054
Study First Received: October 18, 2007
Results First Received: April 6, 2011
Last Updated: November 10, 2011
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Rochester:
Bortezomib
Bendamustine
Rituximab
Relapsed
Refractory
Mantle Cell
Indolent

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine
Nitrogen Mustard Compounds
Rituximab
Bortezomib
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 28, 2014