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Trial of VELCADE and Rituxan as Front-line Tx for Low-grade NHL

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ClinicalTrials.gov Identifier: NCT00369707
Recruitment Status : Active, not recruiting
First Posted : August 29, 2006
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
Robert H. Lurie Cancer Center
Information provided by (Responsible Party):
Northwestern University

Brief Summary:

Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with rituximab may kill more cancer cells.

This phase II trial is studying how well giving bortezomib together with rituximab works as first-line therapy in treating patients with low-grade B-cell non-Hodgkin's lymphoma.


Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: Rituximab Drug: bortezomib Phase 2

Detailed Description:

This is a multicenter, prospective study.

  • Induction therapy: Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 of all subsequent courses. Treatment repeats every 35 days for 3 courses. Patients achieving a complete response, partial response, or stable disease proceed to maintenance therapy.
  • Maintenance therapy: Beginning 6-8 weeks after induction therapy, patients receive bortezomib IV over 3-5 seconds and rituximab IV on day 1. Treatment repeats every 60 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Blood and tissue samples are collected at baseline and periodically during study treatment.

After completion of study therapy, patients are followed every 3 months for 2 years.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Combination Bortezomib and Rituximab as Front-line Therapy for Low-grade Non-Hodgkin's Lymphoma
Study Start Date : August 2006
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Bortezomib and Rituximab
On days 1, 8, 15 and 22 of the 1st cycle, bortezomib will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab. How long it will take to infuse the dose of rituximab is dependent upon your weight and how well you tolerate the infusion; it is estimated this first infusion may take between 3-4 hours. During subsequent cycles, bortezomib will again be given on days 1, 8, 15 and 22. However, rituximab will only be given on day 1 of each cycle.
Drug: Rituximab
On days 1, 8, 15 and 22 of the 1st cycle, bortezomib will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab. How long it will take to infuse the dose of rituximab is dependent upon your weight and how well you tolerate the infusion; it is estimated this first infusion may take between 3-4 hours. During subsequent cycles, bortezomib will again be given on days 1, 8, 15 and 22. However, rituximab will only be given on day 1 of each cycle.
Other Name: Rituxan

Drug: bortezomib
On days 1, 8, 15 and 22 of the 1st cycle, bortezomib will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab. How long it will take to infuse the dose of rituximab is dependent upon your weight and how well you tolerate the infusion; it is estimated this first infusion may take between 3-4 hours. During subsequent cycles, bortezomib will again be given on days 1, 8, 15 and 22. However, rituximab will only be given on day 1 of each cycle.
Other Name: Velcade, PS-341




Primary Outcome Measures :
  1. Overall response rate (complete response and partial response) [ Time Frame: baseline, every 2 months at the completion of cycles 1, 2 and 3 and 2 months after cycle 3 completion and then every 6 mo for 2 yrs ]
    The primary objective of this study is to assess the overall response rate (complete response [CR] plus partial response [PR]) after 3 cycles of bortezomib/rituximab induction therapy for patients with previously untreated low-grade, B-cell NHL.


Secondary Outcome Measures :
  1. Overall response rate after 1 course of induction therapy [ Time Frame: every 2 months at the completion of cycles 1, 2 and 3 and 2 months after cycle 3 completion ]
    Overall response rate (ORR) after 1 cycle of bortezomib/rituximab induction therapy.

  2. Overall response rate after completion of maintenance therapy [ Time Frame: every 2 months at the completion of cycles 1, 2 and 3 and 2 months after cycle 3 completion ]
    Overall response rate at completion of bortezomib/rituximab maintenance therapy.

  3. Duration of response [ Time Frame: every 2 months for 8 months then every 6 mos for 2 yrs ]
    Duration of response, Time to progression, Progression free survival, and Time to treatment failure.

  4. Safety and tolerability [ Time Frame: Day 1 of each cycle and at the completion of cycles 1 and 3 ]
    Assess the safety and tolerance of bortezomib/rituximab as induction and maintenance therapy.

  5. Tissue evaluation [ Time Frame: baseline and at response assessment 1, 2 and 3 ]
    Tissue microarray analysis from paraffin embedded tissue, gene expression profiling from frozen tissue (both from initial node biopsy collected/stored) and whole blood analysis of FCγR polymorphism

  6. Correlation of tumor burden [ Time Frame: End of study ]
    Correlation of tumor burden according to Groupe D'Etude des Lymphomes Follicularies (GELF) with recently developed Follicular Lymphoma International Prognostic Index (FLIPI) prognostic index.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed low-grade B-lymphocyte non-Hodgkins lymphoma
  • Life expectancy > 12 months

Exclusion Criteria:

  • No known history of HIV infection
  • No other active infection
  • No peripheral neuropathy ≥ grade 2 within the past 14 days
  • No uncontrolled hypertension
  • None of the following cardiac conditions:

    • Myocardial infarction within the past 6 months
    • No heart failure
    • Uncontrolled angina
    • Severe uncontrolled ventricular arrhythmias
    • Electrocardiographic evidence of acute ischemia
    • Active conduction system abnormalities
  • No serious medical or psychiatric illness that would preclude study compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior therapy for non-Hodgkins lymphoma
  • No prior bortezomib or rituximab
  • At least 3 weeks since prior chemotherapy, radiation therapy, immunotherapy, systemic anticancer biologic therapy, or anticancer hormonal therapy
  • At least 2 weeks since prior investigational drugs
  • No other concurrent systemic cytotoxic chemotherapy or investigational agents + No leukemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00369707


Locations
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
United States, Illinois
Hematology-Oncology Associates of Illinois
Chicago, Illinois, United States, 60611-2998
Northwestern University
Chicago, Illinois, United States, 60611
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Sponsors and Collaborators
Northwestern University
Robert H. Lurie Cancer Center
Investigators
Principal Investigator: Andrew M. Evens, DO, MS Northwestern University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00369707     History of Changes
Other Study ID Numbers: NU 06H1
STU00005335 ( Other Identifier: Northwestern University IRB )
First Posted: August 29, 2006    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017

Keywords provided by Northwestern University:
Non-Hodgkin's Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Bortezomib
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents