VELCADE® Plus Rituximab in Non Hodgkin's Follicular Lymphoma

NCT01830465 | Completed Phase 2

• 1 other identifier: FOLLREC3
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the efficacy and safety of the combination of Velcade and Rituximab in patients with relapsed Non Hodgkin's Follicular Lymphoma.

Conditions

Non Hodgkin's Follicular Lymphoma

Keywords

Non Hodgkin's Follicular Lymphoma; relapsed; progressed

Outcome Measures

Primary Outcomes (1)

• Antitumor activity after complete treatment

  Evaluate the antitumor activity in terms of clinical and molecular Overall Response Rate (ORR) after 6 courses of Velcade + Rituximab followed by two additional doses of Rituximab alone

  30 days after the last infusion of rituximab

Secondary Outcomes (2)

• Number of patients with adverse events

  From start of treatment until the end of follow up period (three years)

• Antitumor activity after 2 cycles of Velcade alone

  between 1 and 2 weeks after the end of cycle II of Velcade

Study Arms (1)

Bortezomib + Rituximab

EXPERIMENTAL

Single arm. Patients will be treated with Bortezomib, 1,3 mg/m2 intravenous bolus (over 3-5 seconds) on days 1, 4, 8, 11 of 21 day cycle for 6 cycles and Rituximab 375 mg/m2 intravenous infusion on day 1 of cycle III, IV, V, VI. Two additional doses will be administered at week + 3 and week + 6 after cycle VI.

Drug: Bortezomib (VELCADE); Drug: Rituximab

Interventions

Bortezomib (VELCADE) DRUG

1,3 mg/m2, intravenous bolus (over 3-5 seconds) on days 1, 4, 8, 11 of each 21 day cycle. Number of Cycles: 6.

Also known as: VELCADE

Bortezomib + Rituximab

Rituximab DRUG

375 mg/m2 as intravenous infusion on day 1 of cycle III, IV, V, VI. Two additional doses will be administered at week + 3 and week + 6 after cycle VI.

Also known as: Mabthera

Bortezomib + Rituximab

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of relapsed or progressed disease pretreated with no more than three prior chemotherapy regimen and/or immunochemotherapy;
• age \> 18 years;
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
• no evidence of transformation to a high grade lymphoma;
• active disease requiring treatment;
• two-dimensionally measurable disease in at least one site or evaluable disease;
• Velcade® naïve;
• life expectancy \>6 months;
• no prior chemotherapy, immunotherapy or radiotherapy in the last 8 weeks;
• adequate renal function (calculated or measured creatinine clearance \> 30 mL/minute), liver function aspartate aminotransferase (ASAT)/alanine aminotransferase (ALAT) \< 3.0 x upper normal, total bilirubin \< 2,5 x upper normal), unless due to lymphoma involvement;
• left ventricular ejection fraction (LVEF) \> 50%;
• no evidence of active opportunistic infections;
• HbsAg, and hepatitis C virus (HCV) e HIV negativity. Positive serology for hepatitis B virus (HBV) and HCV admitted only upon negativity of HBV-DNA and HCV-RNA tests;
• no serious medical illness likely to interfere with participation in this clinically study;
• voluntary Written Informed Consent before performance of any study-related procedures;

You may not qualify if:

• prior diagnosis of neoplasm (except than follicular lymphoma) within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non melanomatous skin cancer;
• refractory disease (non responding patient to previous treatment);
• other investigational drug within 28 days before enrollment;
• evidence of symptomatic central nervous system (CNS) disease;
• severe impairment of bone marrow function (Absolute Neutrophil Count (ANC) \< 1.5 x 109/L, platelet (PLT) \< 50 x109/L within 14 days before enrollment), unless due to lymphoma involvement;
• evidence of ≥ grade 2 neuropathy within 14 days before enrollment;
• known hypersensitivity to bortezomib, boron or mannitol;
• known hypersensitivity or anaphylactic reactions to murine antibodies or proteins;
• uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 7, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis;
• pregnant or lactating status, confirmation that the subject is no pregnant must be established by a negative serum human chorionic gonadotropin (hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post menopausal or surgically sterilized women;
• any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow up schedule; those conditions should be discussed with the patient before registration in the trial.

Sponsors & Collaborators

• Gruppo Italiano Studio Linfomi: lead

Study Sites (1)

Gruppo Italiano Studio Linfomi

Modena, Modena, 41120, Italy

Location

MeSH Terms

Conditions

Recurrence

Interventions

Bortezomib; Rituximab

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Stefano Sacchi, MD

  Gruppo Italiano Studio Linfomi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2010
• First Posted: April 12, 2013
• Study Start: August 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: May 1, 2011
• Last Updated: April 12, 2013

Record last verified: 2013-04

Locations

IT (1)