Non-randomized Safety Study With Bortezomib/Rituximab in Relapsed/Refractory Indolent Lymphoma
LYM-2023
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
2 other identifiers
interventional
48
1 country
22
Brief Summary
The promising activity of Bortezomib as single agent in low grade lymphoma patients in small studies has led to a number of larger multicenter trials with Bortezomib in combination with Rituximab in mantle-cell lymphoma, follicular lymphoma and marginal zone lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 lymphoma
Started Sep 2006
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 30, 2007
CompletedFirst Posted
Study publicly available on registry
July 31, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedJanuary 28, 2011
July 1, 2009
1.2 years
July 30, 2007
January 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
1 year
Secondary Outcomes (1)
If 12/43 or fewer responses are observed by the end of the trail, then no further investigation of this regimen is warranted
4 years
Study Arms (1)
1
EXPERIMENTALAll patients will be treated with six courses of therapy with a thirteen day rest period between them. Courses will be restarted at day 36.
Interventions
Rituximab 375 mg/m2 as slow iv infusion day 1-8-15-22.Patients will be treated with six courses of therapy with a thirteen day rest period between them. Courses will be restarted at day 36.
VELCADE 1,6 mg/m2 iv bolus days 1-8-15-22 (Velcade will be administrated prior of Rituximab infusion).Patients will be treated with six courses of therapy with a thirteen day rest period between them. Courses will be restarted at day 36.
Eligibility Criteria
You may qualify if:
- 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 entry.
- Age \>18-75
- Relapse or failure to respond after one or more (maximum three) lines of chemotherapy
- Any type of prior chemotherapy, rituximab included. Patients who had received high dose chemotherapy and ASCT can be enrolled into the study
- 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 more.
- Measurable and/or evaluable disease.
- Adequate haematological counts: ANC\> 1.0 x 109/L and PLT counts\> 75 x 109/L unless due to bone marrow involvement by lymphoma.
- Conjugated bilirubin up to 2 x ULN.
- Alkaline phosphatase and transaminases up to 2 x ULN.
- Creatinine clearances\> 30 m/min.
- Non peripheral neuropathy or CNS disease.
- Life expectancy\> 6 months.
- Performance status\< 2 according to ECOG scale.
- Written informed Consent
You may not qualify if:
- Has known or suspected hypersensitivity or intolerance to rituximab, boron, mannitol, or heparin, if an indwelling catheter is used
- History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
- Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug
- 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
- History of hypotension or has decreased blood pressure (sitting systolic blood pressure SBP 100 mmHg and/or sitting diastolic blood pressure DBP 60 mmHg)
- Pregnant or breastfeeding
- Peripheral Neuropathy or Neuropathic Pain Grade 2
- HIV positivity
- HBV positivity with the exception of patients with HBVcAb +, HbsAg -, HBs Ab+/- with HBV-DNA negative
- HCV positivity with the exception of patients with no signs of active chronic hepatitis histologically confirmed
- Active opportunistic infection
- Receipt of extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 4 weeks before enrollment
- Exposure to Rituximab within 24 weeks before screening
- 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 study.
- Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Ospedale Cardinale Panico
Tricase, Lecce, Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy
Istituto per la ricerca e la cura del cancro
Candiolo, Torino, Italy
Ospedale Civico
Chivasso, Torino, Italy
Stabilimento Ospedaliero
Cirié, Torino, Italy
ASO SS Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Ospedale Oncologico
Bari, Italy
Policlinico S.Orsola Malpighi
Bologna, Italy
Spedali Civili
Brescia, Italy
Ospedale Armando Businco
Cagliari, Italy
ASO S. Croce e Carle
Cuneo, Italy
Az. Ospedaliero Universitaria Careggi
Florence, Italy
IRCCS San Raffaele
Milan, Italy
Ospedale Cà Granda Niguarda
Milan, Italy
Univ. Studi Federico II
Napoli, Italy
ASO Maggiore della Carità Ematologia
Novara, Italy
Policlinico Monteluce
Perugia, Italy
Ospedale Bianchi-Melacrino-Morelli
Reggio Calabria, Italy
Università La sapienza Policlinico Umberto I
Roma, Italy
Spedali Riuniti
Siena, Italy
ASO San Giovanni Battista SC Ematologia 2
Torino, Italy
Policlinico Universitario
Udine, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Umberto Vitolo, MD
S.C. Ematologia 2 ASO San Giovanni Battista Torino
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 30, 2007
First Posted
July 31, 2007
Study Start
September 1, 2006
Primary Completion
November 1, 2007
Study Completion
January 1, 2011
Last Updated
January 28, 2011
Record last verified: 2009-07