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Bortezomib (Velcade) With Standard Chemotherapy for Relapsed or Refractory Follicular Lymphoma

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma, Follicular

Intervention: Bortezomib (Drug); Rituximab (Drug); Fludarabine (Drug); Mitoxantrone (Drug); Dexamethasone (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
David A Rizzieri, MD, Principal Investigator, Affiliation: Duke University

Summary

The purpose of this study is to evaluate the effectiveness and safety of combining bortezomib (Velcade) with rituximab, fludarabine, mitoxantrone, and dexamethasone in treating patients with follicular cell lymphoma.

Clinical Details

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

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

Primary outcome: Complete and Partial Response

Secondary outcome:

Duration of Response

Percentage of Subjects Experiencing Progression Free Survival

Percentage of Subjects Experiencing Overall Survival

Number of Participants With a Grade 3-4 Hematologic Toxicity.

Number of Participants With Neuropathy, Any Grade

Detailed description: 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 Pneumocystis carinii Pneumonia (PCP) prophylaxis with Trimethoprim/sulfamethoxazole (TMP/Sulfa) or equivalent agent. On day 4 the physician has the option of starting granulocyte colony-stimulating factor (GCSF), granulocyte macrophage colony-stimulating factor (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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

- aspartate aminotransferase (AST),alanine aminotransferase (ALT), total bilirubin < 3

times the upper limit of normal unless documented by the treating physician to be secondary to underlying lymphoma.

- Eastern Cooperative Oncology Group (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,

Multigated Acquisition (MUGA) or cardiac MRI.

Locations and Contacts

Duke University Medical Center, Durham, North Carolina 27710, United States
Additional Information

Duke Hematologic Malignancy Program

Starting date: January 2007
Last updated: April 29, 2014

Page last updated: August 23, 2015

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