LymphomaPhase 2LYM-2023NCT00509379

Non-randomized Safety Study With Bortezomib/Rituximab in Relapsed/Refractory Indolent Lymphoma

A Phase 2 study testing Rituximab and VELCADE in people with Lymphoma and Non-Hodgkin Lymphoma, run by Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie at 22 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Lymphoma, Non-Hodgkin Lymphoma
What is being tested?: Rituximab and VELCADE
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 22 sitesItaly
Study dates: Sep 2006to Jan 2011
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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

Who cannot join

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

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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

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

Italy22 sites

ASO SS Antonio e Biagio e Cesare Arrigo
Alessandria
Ospedale Oncologico
Bari
Policlinico S.Orsola Malpighi
Bologna
Spedali Civili
Brescia
Ospedale Armando Businco
Cagliari
Istituto per la ricerca e la cura del cancro
Candiolo, Torino
Ospedale Civico
Chivasso, Torino
Stabilimento Ospedaliero
Cirié, Torino
ASO S. Croce e Carle
Cuneo
Az. Ospedaliero Universitaria Careggi
Florence
IRCCS San Raffaele
Milan
Ospedale Cà Granda Niguarda
Milan
Univ. Studi Federico II
Naples
ASO Maggiore della Carità Ematologia
Novara
Policlinico Monteluce
Perugia
Ospedale Bianchi-Melacrino-Morelli
Reggio Calabria
Università La sapienza Policlinico Umberto I
Roma
Istituto Clinico Humanitas
Rozzano, Milano
Spedali Riuniti
Siena
ASO San Giovanni Battista SC Ematologia 2
Torino
Ospedale Cardinale Panico
Tricase, Lecce
Policlinico Universitario
Udine

Other trials in Italy

About this study

Official title: 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

Read the detailed description

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.

Conditions: Lymphoma, Non-Hodgkin Lymphoma
Being tested: Rituximab, VELCADE
Keywords: 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
Medical subject headings: Lymphoma, Lymphoma, Non-Hodgkin, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RituximabDrug
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.
VELCADEDrug
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.

Study groups in NCT00509379
Study group	Role	What they receive
1	Experimental	All patients will be treated with six courses of therapy with a thirteen day rest period between them. Courses will be restarted at day 36. Receives: Drug: Rituximab; Drug: VELCADE

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2006Jan 2011

First posted31 Jul 2007 (estimated)
Study startSep 2006
Primary completionNov 2007
Study completionJan 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for LymphomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00509379
Sponsor's protocol ID: BRIL06
Other IDs: LYM-2023
Acronym: LYM-2023
Status last verified: Jul 2009
First submitted: 30 Jul 2007
Last updated: 28 Jan 2011
Results posted: No
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00509379
Acronym / sponsor ID: LYM-2023 / BRIL06
Conditions: Lymphoma, Non-Hodgkin Lymphoma
Keywords: 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
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle LeucemieUniversity, hospital or other
Collaborators: Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte, Fondazione Italiana Linfomi - ETS, University of Turin, Italy
Study start: Sep 2006
Primary completion: Nov 2007 (actual)
Study completion: Jan 2011 (actual)
First posted: 31 Jul 2007 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: Rituximab, Drug: VELCADEAll patients will be treated with six courses of therapy with a thirteen day rest period between them. Courses will be restarted at day 36.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

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.

Key exclusion criteria (15 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RituximabRituximab 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.	Drug	1
VELCADEVELCADE 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.	Drug	1

Primary outcome

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
Time frame: 1 year

1 secondary outcome

If 12/43 or fewer responses are observed by the end of the trail, then no further investigation of this regimen is warranted
Time frame: 4 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2011.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Umberto Vitolo, MD principal investigator

S.C. Ematologia 2 ASO San Giovanni Battista Torino

22 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab and VELCADE in people with Lymphoma and Non-Hodgkin Lymphoma, run by Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie at 22 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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 (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00509379.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2011.