Fase II Study With BRB for Non-Hodgkin Lymphoplasmacytic Lymphoma/Waldenstrom Macroglobulinemia's

• Register: ClinicalTrials.gov
• Last refreshed on: 11 January 2021
• Main ID: NCT02371148
• Date of registration: 13/02/2015
• Prospective Registration: No
• Primary sponsor: Fondazione Italiana Linfomi ONLUS
• Public title: Fase II Study With BRB for Non-Hodgkin Lymphoplasmacytic Lymphoma/Waldenstrom Macroglobulinemia's FIL_BRB
• Scientific title: Fase II Study With Bortezomib, Rituximab and Bendamustin-BRB- for Non-Hodgkin Lymphoplasmocytic Lymphoma/Waldenstrom Macroglobulinemia's Patients at First Relapse
• Date of first enrolment: June 2014
• Target sample size: 38
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02371148
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Italy

Contacts

• Name: Giulia Benevolo, MD
• Affiliation: SC EMATOLOGIA - AO CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO

• Name: Lorella Orsucci, MD
• Affiliation: SC EMATOLOGIA - AO CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO

Key inclusion & exclusion criteria

Inclusion Criteria:

- Histological proven diagnosis of Lymphoplasmacytic/cytoid lymphoma/Waldenstrom
macroglobulinemia according to REAL/WHO Classification

- Relapsed/refractory disease after receiving one line chemotherapy (rituximab). If
patients received bortezomib or bendamustine and have obtained a partial response
lasting at least two years.

- Age >= 18

- Presence of at least one of the following criteria for the definition of active
disease: Systemic symptoms or Hemoglobin less than 10 g/dL (due to lymphoma) or
Platelets less than 100 x 109/L (due to lymphoma) or symptomatic splenomegaly or Bulky
disease (>7 cm) or Hyperviscosity syndrome, peripheral neuropathy up to grade 1
(Waldenstrom's disease-related), hemolytic anemia, and immune complex vasculitis

- Life expectancy >6 months

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- left ventricular ejection fraction (LVEF) =45% or FS =37%

- Creatinine up to 1.5 x upper limit of normal

- Conjugated bilirubin up to 2 x upper limit of normal

- Alkaline phosphatase and transaminases up to 2 x upper limit of normal

- Written informed content

Exclusion Criteria:

- Patients who received bortezomib or bendamustine first-line therapy, that or haven't
obtained at least partial response nor partial response lasting at least two years.

- Patients not agreeing to take adequate contraceptive precautions during and for at
least 6 months after cessation of therapy

- History of other malignancies within 3 years prior to study entry except for:
adequately treated carcinoma in situ of the cervix; basal or squamous cell skin
cancer; low grade, early stage, localized prostate cancer treated surgically with
curative intent; good prognosis ductal carcinoma in situ (DCIS) of the breast treated
with lumpectomy alone with curative intent

- Medical condition requiring long term use (>1 months) of systemic corticosteroids

- Active bacterial, viral, or fungal infection requiring systemic therapy

- Peripheral neuropathy of any grade = 2 [see Appendix Section A]

- Concurrent medical condition which might exclude administration of therapy

- Cardiac insufficiency (NYHA grade III/IV)

- Myocardial infarction within 6 months of entry on study

- Severe chronic obstructive pulmonary disease with hypoxemia

- Severe diabetes mellitus difficult to control with adequate insulin therapy

- Hypertension that is difficult to control

- Impaired renal function with creatinine clearance <30 ml/min

- HIV positivity HBV positivity with the exception of patients HbsAg and HBV-DNA
negative and Ab anti-HB core positive (these patients need to receive prophylaxis with
Lamivudine)

- HCV positivity with the exception of patients with HCV RNA negative

- Participation at the same time in another study in with investigational drugs are used

- Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins

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

- Women in pregnancy or breastfeeding



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Waldenstrom's Macroglobulinemia

Intervention(s)

Drug: Bortezomib-Rituximab-Bendamustine

Primary Outcome(s)

Progression Free Survival (PFS) [Time Frame: 18 months]

Secondary Outcome(s)

Overall Response Rate (ORR) [Time Frame: 2 years]

Toxicity [Time Frame: 2 years]

Overall Survival (OS) [Time Frame: 2 years]

Number of serious adverse events [Time Frame: 2 years]

Secondary ID(s)

FIL_BRB

Source(s) of Monetary Support

Please refer to primary and secondary sponsors