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Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT01029730•SCRI Development Innovations, LLC

View on ClinicalTrials.gov

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. This combination uses the standard bendamustine dosing schedule, and is more convenient than the 5-week regimen of these 3 drugs currently being studied.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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
•2. At least one of the following criteria must be met:
•* 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
+14 more criteria

Exclusion Criteria

•1. The patient has chronic lymphocytic leukemia.
•2. The patient has transformed lymphoma.
•3. History of, or clinically apparent, central nervous system (CNS) lymphoma or leptomeningeal lymphoma.
•4. 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.
•5. Peripheral neuropathy ≥ CTCAE v3.0 grade 2, ≤14 days of study enrollment.
•6. 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.
•7. History of solid organ transplantation, or post-transplant lymphoproliferative disorder.
•8. Patients with known history of hepatitis B or hepatitis C infection. Hepatitis B surface antigen must be tested.
•9. The patient has known human immunodeficiency virus (HIV) infection.
•10. Active, clinically serious infection \> grade 2. Patients may be eligible upon resolution of the infection.
+6 more criteria

Locations (20)

NEA Baptist Clinic

Jonesboro, Arkansas, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Hematology Oncology of the North Shore

Skokie, Illinois, United States

Providence Medical Group

Terre Haute, Indiana, United States

Baptist Hospital East

Louisville, Kentucky, United States

Hematology Oncology Clinic, LLP

Baton Rouge, Louisiana, United States

Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

National Capital Clinical Research Consortium

Bethesda, Maryland, United States

Key Dates

Start Date

March 1, 2010

Primary Completion Date

October 1, 2014

Completion Date

July 1, 2016

Last Updated

August 19, 2016

Enrollment

ACTUAL participants

Conditions

Lymphoma

Interventions

Bendamustine

DRUG

Bortezomib

DRUG

Rituximab

DRUG

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

NCT07388563

Lymphoma, T Cell, PeripheralT-cell Lymphoma+4 more

View study

RECRUITINGPHASE2

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

NCT06263491

Mantle Cell Lymphoma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 19, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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