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

Non-Hodgkin's Lymphoma Clinical Trial

— BVR  

Official title:

Pilot Study of Bortezomib, Bendamustine and Rituximab for Patients With Relapsed or Refractory, Indolent or Mantle Cell Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00547534
• Other study ID #: ULYM07054
• Status: Completed
• Phase: Phase 2
• First received: October 18, 2007
• Last updated: July 15, 2015
• Start date: October 2007
• Est. completion date: October 2009

Study information

• Verified date: July 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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of any study-specific procedure not part of routine medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• bortezomib
1.3 mg/m^2 on days 1, 4, 8, 11
• bendamustine
90 mg/m^2 days 1 and 4
• rituximab
375 mg/m^2 day 1

Locations

Country	Name	City	State
United States	Cornell Wiell Medical College	New York	New York
United States	Nebraska Medical Center	Omaha	Nebraska
United States	University of Rochester Medical Center (James P. Wilmot Cancer Center)	Rochester	New York

Sponsors (3)

Lead Sponsor	Collaborator
University of Rochester	Cephalon, Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Progression Free Survival at 2 Years	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.	Two years	No
Secondary	Toxicity of Drug Combination in the Subjects		Two years	Yes
Secondary	Overall Response Rate (ORR)	Overall response rate (ORR)to protocol treatment - Partial response, Complete response, etc.	Two years	No