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A Phase II Study of Bortezomib in Combination With Rituximab, Fludarabine, Mitoxantrone, and Dexamethasone (VR-FND) for Relapsed or Refractory Follicular Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, Follicular

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Trial Information

A Phase II Study of Bortezomib in Combination With Rituximab, Fludarabine, Mitoxantrone, and Dexamethasone (VR-FND) for Relapsed or Refractory Follicular Lymphoma


This is a phase II study using the combination of bortezomib, rituximab, fludarabine,
mitoxantrone and dexamethasone. The combination will given over a 28 day cycle. In addition
each patient will receive PCP prophylaxis with TMP/Sulfa or equivalent agent. On day 4 the
physician has the option of starting GCSF, GMCSF, or pegylated GCSF.

All patients who receive at least one dose of the drug will be evaluated for toxicity.
Patients will be treated with the agent for at least 2 cycles to be considered eligible for
evaluation of response. The chemotherapy dosing will continue until there is evidence of
disease progression, a second recurrence of unacceptable toxicity, or a maximum of 8 courses
of therapy.


Inclusion Criteria:



- Diagnosis of grade 1-3 follicular lymphoma with persistent, relapsed, or refractory
disease to at least one prior regimen.

- No prior bortezomib therapy.

- Voluntary written informed consent.

- Female subject is either post-menopausal or surgically sterilized or willing to use
an acceptable method of birth control.

- Male subject agrees to use an acceptable method for contraception for the duration of
the study therapy.

- 18 years of age or older.

- AST, ALT, total bilirubin < 3 times the upper limit of normal unless documented by
the treating physician to be secondary to underlying lymphoma.

- ECOG performance status 0-2.

Exclusion Criteria:

- Platelet count of < 50,000 within 14 days before enrollment unless documented by the
treating physician to be due to the disease.

- Absolute neutrophil count of < 1000 within 14 days before enrollment unless
documented by the treating physician to be due to disease.

- Estimated or measured creatinine clearance of less than 30 ml/min within 14 days
before enrollment.

- ≥Grade 2 peripheral neuropathy within 14 days before enrollment.

- Myocardial infarction within 6 months prior to enrollment or has New York Hospital
Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe
uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
ischemia.

- Patient has hypersensitivity to boron, mannitol or any drug included in the current
protocol.

- Female subject is pregnant or lactating.

- Received other investigational drugs for this disease within 14 days of enrollment

- Serious medical or psychiatric illness likely to interfere with participation in this
clinical study.

- Known HIV+ status.

- Cardiac ejection fraction less than 35% at study entry measured by echocardiogram,
MUGA or cardiac MRI.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

complete and partial response

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

David A Rizzieri, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Institutional Review Board

Study ID:

Pro00008487

NCT ID:

NCT00510887

Start Date:

January 2007

Completion Date:

September 2013

Related Keywords:

  • Lymphoma, Follicular
  • follicular lymphoma
  • Velcade
  • VR-FND
  • Lymphoma
  • Lymphoma, Follicular

Name

Location

Duke University Medical CenterDurham, North Carolina  27710