Fase II Study With BRB for Non-Hodgkin Lymphoplasmacytic Lymphoma/Waldenstrom Macroglobulinemia's
NCT ID: NCT02371148
Last Updated: 2020-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
38 participants
INTERVENTIONAL
2014-06-30
2020-07-22
Brief Summary
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Detailed Description
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The Investigators would consider a positive result to increase 18 months-PFS rate from 50 to 65%.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bortezomib-Rituximab-Bendamustine
Bortezomib-Rituximab-Bendamustine (BRB) combination in patients with relapsed/refractory lymphoplasmocytic/lymphoplasmocytoid lymphoma/Waldenstrom macroglobulinemia after one line of therapy.
Bortezomib-Rituximab-Bendamustine
Bortezomib-Rituximab-Bendamustine Bortezomib: 1.3 mg/mq sc days 1, 8, 15, 22\* Rituximab: 375 mg/sqm i.v. day 1\*\* Bendamustine: 90 mg/sqm iv days 1-2 or days 2-3 according to institutional/physician choice Repeat cycles every 28 days for a total of 6 cycles \*In case of toxicity is omitted
\*\*In cycles 1, in order to avoid tumor lysis syndrome, Rituximab will be given on day 8
Interventions
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Bortezomib-Rituximab-Bendamustine
Bortezomib-Rituximab-Bendamustine Bortezomib: 1.3 mg/mq sc days 1, 8, 15, 22\* Rituximab: 375 mg/sqm i.v. day 1\*\* Bendamustine: 90 mg/sqm iv days 1-2 or days 2-3 according to institutional/physician choice Repeat cycles every 28 days for a total of 6 cycles \*In case of toxicity is omitted
\*\*In cycles 1, in order to avoid tumor lysis syndrome, Rituximab will be given on day 8
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
Yes
Sponsors
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Fondazione Italiana Linfomi - ETS
OTHER
Responsible Party
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Principal Investigators
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Lorella Orsucci, MD
Role: PRINCIPAL_INVESTIGATOR
SC EMATOLOGIA - AO CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO
Giulia Benevolo, MD
Role: PRINCIPAL_INVESTIGATOR
SC EMATOLOGIA - AO CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO
Locations
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AO Riuniti Papardo Piemonte
Messina, ME, Italy
Centro di Riferimento Oncologico della Basilicata
Rionero in Vulture, PZ, Italy
AUSL di Ravenna
Ravenna, RA, Italy
A.O. Bianchi - Melacrino - Morelli
Reggio Calabria, RC, Italy
Nuovo Regina Margherita
Roma, RM, Italy
Uo Oncoematologia, Po "A.Tortora"
Pagani, Salerno, Italy
Ospedale S. Giacomo di Castelfranco Veneto
Castelfranco Veneto, Treviso, Italy
A.O. SS. Antonio e Biagio e C. Arrigo
Alessandria, , Italy
A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona
Ancona, , Italy
Centro di riferimento Oncologico - Oncologia Medica A
Aviano (PN), , Italy
A.O. Ospedale Degli Infermi
Biella, , Italy
Ospedale Businco, Divisione di Ematologia
Cagliari, , Italy
Area Vasta Romagna e IRST
Meldola (FC), , Italy
Irccs Ospedale Maggiore Policlinico Di Milano
Milan, , Italy
A.O. Universitaria Policlinico Di Modena
Modena, , Italy
Ospedale Maggiore Della Carita' - Scdu Ematologia
Novara, , Italy
Ospedale San Martino, Asl Oristano- Ematologia
Oristano, , Italy
Ematologia Policlinico San Matteo
Pavia, , Italy
Ausl Di Piacenza
Piacenza, , Italy
Ausl Di Rimini
Rimini, , Italy
Ematologia 1 - A.O. Citta' Della Salute E Della Scienza Di Torino
Torino, , Italy
Città della Salute e della Scienza SC Ematologia
Torino, , Italy
Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI
Varese, , Italy
Countries
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Other Identifiers
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FIL_BRB
Identifier Type: -
Identifier Source: org_study_id