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Phase II Study of VELCADE in Combination With Rituximab in Patients With Relapsed or Progressed Non Hodgkin's Follicular Lymphoma

Phase 2
18 Years
90 Years
Not Enrolling
Non Hodgkin's Follicular Lymphoma

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Trial Information

Phase II Study of VELCADE in Combination With Rituximab in Patients With Relapsed or Progressed Non Hodgkin's Follicular Lymphoma

Eligible patients will receive the combination Velcade-rituximab for up to a total of 6
cycles of Velcade and 6 infusion of rituximab.

Patients will be evaluated for clinical, laboratory, imaging parameters at baseline, during
study treatment, at the end of the treatment and during follow up (every 6 months for 3
years). In the first stage, 17 patients will be treated. An interim analysis will be
performed after recruitment of the first 17 evaluable patients. Aim of this analysis is to
determine preliminary the activity of the treatment.If > 7 responses are observed, the
accrual is continued and 24 additional patients are treated up to a total of 41. If ≤ 21
respond, the treatment is rejected as ineffective. If 22 or more respond, the treatment is
judged promising for further development.

Inclusion Criteria:

Each patient must meet all of the following inclusion criteria to be enrolled in the

- 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

- 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

- voluntary Written Informed Consent before performance of any study-related

- patient is able (i.e. sufficiently fluent) and willing to complete the quality of
life questionnaires in validated translations. Inability (illiteracy, loss of sight,
or other equivalent reason) to complete the questionnaires will not make the patient
ineligible for the study. However, ability but unwillingness to complete the
questionnaires will make the patient ineligible; 17. female subject is either
post-menopausal or surgically sterilized or willing to use an acceptable method of
birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with
spermicide, condom with spermicide, or abstinence) for the duration of the study.
Male subject agrees to use an acceptable method for contraception for the duration of
the study;

Exclusion Criteria:

- prior diagnosis of neoplasm (except than follicular lymphoma) within 5 years, except
cervical intraepithelial neoplasia type 1 (CIN1) or localized non melanomatous skin

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Antitumor activity after complete treatment

Outcome Description:

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

Outcome Time Frame:

30 days after the last infusion of rituximab

Safety Issue:


Principal Investigator

Stefano Sacchi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gruppo Italiano Studio Linfomi


Italy: Ethics Committee

Study ID:




Start Date:

August 2006

Completion Date:

May 2011

Related Keywords:

  • Non Hodgkin's Follicular Lymphoma
  • Non Hodgkin's Follicular Lymphoma
  • relapsed
  • progressed
  • Lymphoma
  • Lymphoma, Follicular