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Pilot Study of Bortezomib, Bendamustine and Rituximab on Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: University of Rochester
Millennium Pharmaceuticals, Inc.
Cephalon
Information provided by: University of Rochester
ClinicalTrials.gov Identifier: NCT00547534
  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 (good and bad) these drugs have on you and on your cancer.


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

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Rituximab Bortezomib Bendamustine Bendamustine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Pilot Study of Bortezomib, Bendamustine and Rituximab for Patients With Relapsed or Refractory, Indolent or Mantle Cell Non-Hodgkin's Lymphoma

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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. [ Time Frame: Two years ]

Secondary Outcome Measures:
  • • Determine safety and toxicity of BVR combination in patients with relapsed or refractory indolent and mantle cell NHL • Determine ORR following BVR combination therapy in patients with relapsed or refractory indolent or mantle cell NHL [ Time Frame: Two years ]

Estimated Enrollment: 30
Study Start Date: October 2007
Estimated Study Completion Date: October 2009
Arms Assigned Interventions
A, 2, III: Experimental Drug: bortezomib
1.3 mg/m2 on days 1, 4, 8, 11
Drug: bendamustine
90 mg/m2 days 1 and 4
Drug: rituximab
375 mg/m2 day 1

  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of any study-specific procedure not part of routine medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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 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 (see section 3.6.1.4)
  • Patients must have measurable disease or an indication to receive additional therapy

Exclusion Criteria:

  • Patient has platelet count of ≤75,000/mm3 within 14 days before enrollment.
  • Patient has absolute neutrophil count of < 1,000/mm3 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547534

Locations
United States, New York
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

Study ID Numbers: ULYM07054
Study First Received: October 18, 2007
Last Updated: October 18, 2007
ClinicalTrials.gov Identifier: NCT00547534  
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

Study placed in the following topic categories:
Lymphatic Diseases
Immunoproliferative Disorders
Rituximab
Bortezomib
Lymphoma, small cleaved-cell, diffuse
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Bendamustine

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Enzyme Inhibitors
Antirheumatic Agents
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009