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A Phase II Multicenter Non-randomized Study to Assess Safety, Toxicity and Clinical Activity of the Association of Bortezomib(VELCADE)With Rituximab in Relapsed/Refractory Indolent Non Follicular and Mantle-cell Non-Hodgkin Lymphoma

Phase 2
18 Years
75 Years
Not Enrolling
Lymphoma, Non-Hodgkin Lymphoma

Thank you

Trial Information

A Phase II Multicenter Non-randomized Study to Assess Safety, Toxicity and Clinical Activity of the Association of Bortezomib(VELCADE)With Rituximab in Relapsed/Refractory Indolent Non Follicular and Mantle-cell Non-Hodgkin Lymphoma

This is a open label, non randomized, phase II , multicenter, prospective trial to evaluate
the efficacy and safety of the combination of bortezomib and rituximab in patients with
relapsed or refractory rituximab naïve or sensitive indolent non-follicular and mantle cell
non-Hodgkin's lymphoma. Despite of the availability of treatment for this disease, this
study is justified because no known therapies are really curative and it is necessary to
look for new treatment options to improve the clinical outcome and prognosis of relapsed
indolent lymphoma. This study is designed for patients not eligible for high-dose
chemotherapy and autologous stem cells transplantation.

Inclusion Criteria:

1. Patients with naïve or sensitive rituximab indolent non-follicular and mantle cell
non-Hodgkin's Lymphoma disease that had failed to respond or relapsed after primary
therapy. There is a demonstrated progressive disease requiring further treatment.
Histological subtype included into the study are are as follows Small
lymphocytic/lymphoplasmocytic lymphoma; Nodal marginal zone Lymphoma (MALT lymphoma
are excluded) Splenic marginal zone lymphoma Mantle cell lymphoma A lymphnode biopsy
is advisable if it is not harmful for the patients, before enrollment of the patient
into the study in order to confirm diagnosis and to rule out histologic
transformation. Lymphnode biopsy should be performed within 6 months before study

2. Age >18-75

3. Relapse or failure to respond after one or more (maximum three) lines of chemotherapy

4. Any type of prior chemotherapy, rituximab included. Patients who had received high
dose chemotherapy and ASCT can be enrolled into the study

5. Naïve or sensitive rituximab disease. If the patient received Rituximab, he/she must
have responded and the TTP from the last dose to rituximab must have been 6 months or

6. Measurable and/or evaluable disease.

7. Adequate haematological counts: ANC> 1.0 x 109/L and PLT counts> 75 x 109/L unless
due to bone marrow involvement by lymphoma.

8. Conjugated bilirubin up to 2 x ULN.

9. Alkaline phosphatase and transaminases up to 2 x ULN.

10. Creatinine clearances> 30 m/min.

11. Non peripheral neuropathy or CNS disease.

12. Life expectancy> 6 months.

13. Performance status< 2 according to ECOG scale.

14. Written informed Consent

Exclusion Criteria:

1. Has known or suspected hypersensitivity or intolerance to rituximab, boron, mannitol,
or heparin, if an indwelling catheter is used

2. History of clinically relevant liver or renal insufficiency; significant cardiac,
vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic,
hematologic, psychiatric, or metabolic disturbances

3. Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable
dose for at least 3 months before first dose of study drug

4. 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 5, NYHA Classification of Cardiac Disease), uncontrolled angina,
clinically significant pericardial disease, or cardiac amyloidosis

5. History of hypotension or has decreased blood pressure (sitting systolic blood
pressure SBP 100 mmHg and/or sitting diastolic blood pressure DBP 60 mmHg)

6. Pregnant or breastfeeding

7. Peripheral Neuropathy or Neuropathic Pain Grade 2

8. HIV positivity

9. HBV positivity with the exception of patients with HBVcAb +, HbsAg -, HBs Ab+/- with
HBV-DNA negative

10. HCV positivity with the exception of patients with no signs of active chronic
hepatitis histologically confirmed

11. Active opportunistic infection

12. Receipt of extensive radiation therapy, systemic chemotherapy, or other
antineoplastic therapy within 4 weeks before enrollment

13. Exposure to Rituximab within 24 weeks before screening

14. Have received an experimental drug or used an experimental medical device within 4
weeks before the planned start of treatment. Concurrent participation in
non-treatment studies is allowed, if it will not interfere with participation in this

15. Any other co-existing medical or psychological condition that would preclude
participation in the study or compromise ability to give informed consent

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To demonstrate a statistical benefit in overall response rate (ORR) of the Bortezomib/Rituximab association in this study 3/13 or fewer responses are observed during the first stage then the trail is stopped early

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Umberto Vitolo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

S.C. Ematologia 2 ASO San Giovanni Battista Torino


Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study ID:




Start Date:

September 2006

Completion Date:

January 2011

Related Keywords:

  • Lymphoma
  • Non-Hodgkin Lymphoma
  • Relapsed/refractory indolent lymphoma
  • Non-follicular Lymphoma
  • Mantle cell non-Hodgkin Lymphoma
  • Patients naïve or sensitive to rituximab
  • Patients not eligible for high dose chemotherapy with ASCT
  • Lymphoma
  • Lymphoma, Non-Hodgkin