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MALT LYMPHOMAPhase 2NCT01015248

Trial of Bendamustine And Rituximab for Patients With Previously Untreated Extranodal Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma

A Phase 2 study testing Rituximab and Bendamustine in people with MALT LYMPHOMA, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 19 sites in Spain.

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 aim of the study is to assess the therapeutic activity and safety of the combination of Bendamustine and Rituximab in MALT lymphomas. Primary endpoint: Event-free-survival (EFS) (failure or death from any cause) for all patients. Read more about this study

Who is it for?
Ages 18 to 84 years
Conditions the study is for
MALT LYMPHOMA
What is being tested?
Rituximab and Bendamustine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
19 sitesSpain
Study dates
May 2009to Dec 2013
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 84 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site (WHO classification)
  • Any stage (Ann Arbor I-IV)
  • The novo disease en any extranodal site. For primary gastric or cutaneous lymphoma, local/specific previous treatment is accepted, just following the below criteria:
  • Cutaneous lymphoma: recurrent lymphoma after local therapy
  • Gastric lymphoma:
  • b1. H. pylori-negative cases, either de novo (non pre-treated) or at relapse following local therapy (i.e., surgery, radiotherapy or antibiotics).
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  • b2. H. pylori-positive cases at diagnosis, who failed antibiotic therapy, including patients with: clinical (endoscopic) and histological evidence of disease progression at any time post H. pylori eradication; stable disease with persistent lymphoma at 1 year post H. pylori eradication; relapse (without H. pylori re-infection), after a remission; patients who failed either first line antibiotics or further local treatment (surgery or radiotherapy)
  • No evidence of histologic transformation to a high grade lymphoma
  • Measurable or evaluable disease
  • Age >18 and <85
  • ECOG performance status 0-2
  • Life expectancy of at least 1 year
  • Written informed consent given according to national/local regulations

Who cannot join

  • Prior chemotherapy or prior immunotherapy with any anti-CD20 monoclonal antibody
  • Prior radiotherapy in the last 6 weeks
  • Corticosteroids during the last 28 days, unless prednisone chronically administered at a dose <20 mg/day for indications other than lymphoma or lymphoma-related symptoms
  • Major impairment of renal function (serum creatinine > 2,5 x upper normal) or liver function (ASAT/ALAT <2,5 x upper normal, total bilirubin <2,5x upper normal), unless due to lymphoma involvement.
  • Impairment of bone marrow function (WBC <3.0x109/L, ANC <1.5x109/L, PLT <100x109/L), unless due to lymphoma involvement
  • Evidence of clinically significant cardiac, neurological or metabolic disease, unless due to lymphoma involvement
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  • Evidence of symptomatic central nervous system (CNS) disease
  • Active HBV and/or HCV infection
  • Known HIV infection
  • Prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer
  • Any psychiatric disease potentially hampering compliance with the study protocol and follow-up schedule
  • Potential to attend regular visits to the hospital, on an outpatient regimen
  • Hypersensibility to any compound of the study medication.
  • Non appropriate contraceptive method in women of childbearing potential or men
  • Treatment with any drug under research within 30 days previous to start the study medication.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Spain19 sites

  • Hospital Fundación Alcorcón

    Alcorcón, Madrid, 28922

  • ICO-Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08918

  • Hospital del Mar

    Barcelona, Barcelona, 08003

  • ICO-Hospital Durans i Reynals

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital La Princesa

    Madrid, Madrid, 28006

  • Hospital MD Anderson

    Madrid, Madrid, 28033

  • Hospital Ramón y Cajal

    Madrid, Madrid, 28034

  • Hospital 12 de Octubre

    Madrid, Madrid, 28041

  • Hospital La Paz

    Madrid, Madrid, 28046

  • Hospital Morales Meseguer

    Murcia, Murcia, 30008

  • Hospital Central de Asturias

    Oviedo, Principality of Asturias, 33006

  • Hospital Son Llátzer

    Palma de Mallorca, Mallorca, 07198

  • Clínica Universitaria Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario de Salamanca

    Salamanca, Salamanca, 37007

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, Tenerife, 38320

  • Hospital Marqués de Valdecilla

    Santander, Cantabria, 39008

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, La Coruña, 15706

  • Hospital Mutua de Terrassa

    Terrassa, Barcelona, 08221

  • Hospital Clínico de Zaragoza "Lozano Blesa"

    Zaragoza, Zaragoza, 50009

Other trials in Spain

About this study

Official title: Multicentric, Non-Randomized Phase 2 Trial of Bendamustine And Rituximab for Patients With Previously Untreated Extranodal Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma

The aim of the study is to assess the therapeutic activity and safety of the combination of Bendamustine and Rituximab in MALT lymphomas.

Primary endpoint:

  • Event-free-survival (EFS) (failure or death from any cause) for all patients.

Secondary endpoints:

  • Complete and partial remission rates for all patients
  • Response duration (time to relapse or progression) for responder patients
  • Progression-free-survival (PFS) (disease progression or death from lymphoma: for all patients
  • Overall survival for all patients
  • Acute and long-term toxicity
Conditions
MALT LYMPHOMA
Being tested
Rituximab and Bendamustine
Keywords
CD 20 positive
Medical subject headings
Lymphoma, B-Cell, Marginal Zone

What participants receive

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

  • Rituximab and BendamustineDrug

    Rituximab 375 mg/m2 iv. day 1 Bendamustine 90 mg/m2 iv. day 1 and 2

Study groups in NCT01015248
Study groupRoleWhat they receive
Rituximab and BendamustineExperimentalNot described
Receives: Drug: Rituximab and Bendamustine

What is being measured

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

  1. The primary endpoint of assessment is the event-free-survival (EFS) according to the criteria of the International Workshop to Standardize Response Criteria for NHL and Criteria for evaluation of response in NHL

    Measured: 2 years follow-up

Secondary outcomes (1)

  1. Include evaluation of the next parameters: Complete and partial remission rates for all patients Response duration for responder patients PFS for all patients Overall survival for all patients Acute and long-term toxicity

    Measured: 2 years follow-up

Timeline

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

  1. First posted18 Nov 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01015248
Sponsor's protocol ID
MALT2008-01
Other IDs
No EudraCT: 2008-007725-39
Status last verified
Sep 2016
First submitted
17 Nov 2009
Last updated
7 Sep 2016
Results posted
No
Data monitoring committee
No

Publications

  • Salar A, Domingo-Domenech E, Panizo C, Nicolas C, Bargay J, Muntanola A, Canales M, Bello JL, Sancho JM, Tomas JF, Rodriguez MJ, Penalver FJ, Grande C, Sanchez-Blanco JJ, Palomera L, Arranz R, Conde E, Garcia M, Garcia JF, Caballero D, Montalban C; Grupo Espanol de Linfomas/Trasplante de Medula Osea (GELTAMO). First-line response-adapted treatment with the combination of bendamustine and rituximab in patients with mucosa-associated lymphoid tissue lymphoma (MALT2008-01): a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2014 Dec;1(3):e104-11. doi: 10.1016/S2352-3026(14)00021-0. Epub 2014 Nov 19.

    PubMed 27029228

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab and Bendamustine in people with MALT LYMPHOMA, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 19 sites in Spain.

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 13 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 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Spain. 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?

The primary endpoint of assessment is the event-free-survival (EFS) according to the criteria of the International Workshop to Standardize Response Criteria for NHL and Criteria for evaluation of response in NHL (time frame: 2 years follow-up). 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 NCT01015248, which also lists 1 linked publication.

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 7 Sep 2016.

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