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A Phase II Trial of Combination Bortezomib and Rituximab as Front-line Therapy for Low-grade Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

A Phase II Trial of Combination Bortezomib and Rituximab as Front-line Therapy for Low-grade Non-Hodgkin's Lymphoma


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall response rate (complete response and partial response)

Outcome Description:

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.

Outcome 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

Safety Issue:

No

Principal Investigator

Andrew M. Evens, DO, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University

Authority:

United States: Food and Drug Administration

Study ID:

NU 06H1

NCT ID:

NCT00369707

Start Date:

August 2006

Completion Date:

August 2015

Related Keywords:

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

Name

Location
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497
Hematology-Oncology Associates of Illinois Chicago, Illinois  60611-2998
University of Miami Sylvester Comprehensive Cancer Center - Miami Miami, Florida  33136
Northwestern University Chicago, Illinois  60611