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

Phase 2

Completed

Conditions: Non-Hodgkin's Lymphoma

Interventions: Drug: bortezomib
Drug: bendamustine
Drug: rituximab

Registration Number: NCT00547534

Lead Sponsor: University of Rochester

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 31

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of any study-specific procedure not part of routine medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lymphoma Subjects receiving protocol therapy	rituximab	Subjects that met all eligibility criteria and were treated with Bendamustine, Rituxan and Bortezomib.
Lymphoma Subjects receiving protocol therapy	bortezomib	Subjects that met all eligibility criteria and were treated with Bendamustine, Rituxan and Bortezomib.
Lymphoma Subjects receiving protocol therapy	bendamustine	Subjects that met all eligibility criteria and were treated with Bendamustine, Rituxan and Bortezomib.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Progression Free Survival at 2 Years	Two 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.

Secondary Outcome Measures

Name	Time	Method
Toxicity of Drug Combination in the Subjects	Two years
Overall Response Rate (ORR)	Two years	Overall response rate (ORR)to protocol treatment - Partial response, Complete response, etc.

Trial Locations

Locations (3): 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, United States