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

Sponsor
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea (Other)
Overall Status
Completed
CT.gov ID
NCT01015248
Collaborator
(none)
60
Enrollment
19
Locations
1
Arm
55
Duration (Months)
3.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.
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

Condition or Disease Intervention/Treatment Phase
  • Drug: Rituximab and Bendamustine
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multicentric, Non-Randomized Phase 2 Trial of Bendamustine And Rituximab for Patients With Previously Untreated Extranodal Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma
Study Start Date :
May 1, 2009
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rituximab and Bendamustine

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

Outcome Measures

Primary Outcome Measures

  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 [2 years follow-up]

Secondary Outcome Measures

  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 [2 years follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 84 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site (WHO classification)

  2. Any stage (Ann Arbor I-IV)

  3. The novo disease en any extranodal site. For primary gastric or cutaneous lymphoma, local/specific previous treatment is accepted, just following the below criteria:

  4. Cutaneous lymphoma: recurrent lymphoma after local therapy

  5. 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).

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)

  1. No evidence of histologic transformation to a high grade lymphoma

  2. Measurable or evaluable disease

  3. Age >18 and <85

  4. ECOG performance status 0-2

  5. Life expectancy of at least 1 year

  6. Written informed consent given according to national/local regulations

Exclusion Criteria:

  1. Prior chemotherapy or prior immunotherapy with any anti-CD20 monoclonal antibody

  2. Prior radiotherapy in the last 6 weeks

  3. 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

  4. 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.

  5. Impairment of bone marrow function (WBC <3.0x109/L, ANC <1.5x109/L, PLT <100x109/L), unless due to lymphoma involvement

  6. Evidence of clinically significant cardiac, neurological or metabolic disease, unless due to lymphoma involvement

  7. Evidence of symptomatic central nervous system (CNS) disease

  8. Active HBV and/or HCV infection

  9. Known HIV infection

  10. Prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer

  11. Any psychiatric disease potentially hampering compliance with the study protocol and follow-up schedule

  12. Potential to attend regular visits to the hospital, on an outpatient regimen

  13. Hypersensibility to any compound of the study medication.

  14. Non appropriate contraceptive method in women of childbearing potential or men

  15. Treatment with any drug under research within 30 days previous to start the study medication.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Central de Asturias Oviedo Asturias Spain 33006
2 ICO-Hospital Germans Trias i Pujol Badalona Barcelona Spain 08918
3 ICO-Hospital Durans i Reynals Hospitalet de Llobregat Barcelona Spain 08907
4 Hospital Mutua de Terrassa Terrassa Barcelona Spain 08221
5 Hospital Marqués de Valdecilla Santander Cantabria Spain 39008
6 Complejo Hospitalario Universitario de Santiago Santiago de Compostela La Coruña Spain 15706
7 Hospital Fundación Alcorcón Alcorcón Madrid Spain 28922
8 Hospital Son Llátzer Palma de Mallorca Mallorca Spain 07198
9 Clínica Universitaria Navarra Pamplona Navarra Spain 31008
10 Hospital Universitario de Canarias Sta. Cruz de Tenerife Tenerife Spain 38320
11 Hospital del Mar Barcelona Spain 08003
12 Hospital La Princesa Madrid Spain 28006
13 Hospital MD Anderson Madrid Spain 28033
14 Hospital Ramón y Cajal Madrid Spain 28034
15 Hospital 12 de Octubre Madrid Spain 28041
16 Hospital La Paz Madrid Spain 28046
17 Hospital Morales Meseguer Murcia Spain 30008
18 Hospital Universitario de Salamanca Salamanca Spain 37007
19 Hospital Clínico de Zaragoza "Lozano Blesa" Zaragoza Spain 50009

Sponsors and Collaborators

  • Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Investigators

  • Principal Investigator: Carlos Montalbán, MD, Ramon y Cajal Hospital
  • Principal Investigator: Antonio Salar, MD, Hospital del Mar
  • Principal Investigator: Ana Muntañola, MD, Mutua de Terrassa Hospital
  • Principal Investigator: Mª José Rodríguez, MD, Hospital Universitario de Canarias
  • Principal Investigator: María José Terol, MD, Hospital Clínico de Valencia
  • Principal Investigator: Juan Manuel Sancho, MD, ICO Hospital Germans Trias i Pujol
  • Principal Investigator: Eva Domingo, MD, ICO Hospital Durans i Reynals
  • Principal Investigator: Grande Carlos, MD, 12 de Octubre Hospital
  • Principal Investigator: Carlos Panizo, MD, Clínica Universitaria Navarra
  • Principal Investigator: Miguel Canales, MD, La Paz Hospital
  • Principal Investigator: Raquel Oña, MD, MD Anderson Hospital
  • Principal Investigator: Reyes Arranz, MD, La Princesa Hospital
  • Principal Investigator: Dolores Caballero, MD, Hospital Unisversitario de Salamanca
  • Principal Investigator: José Luis Bello, MD, Complejo Hospitalario Universitario de Santiago
  • Principal Investigator: Joan Bargay, MD, Son Llátzer Hospital
  • Principal Investigator: Luis Palomera, MD, Hospital Clínico de Zaragoza
  • Principal Investigator: Franciaco Javier Peñalver, MD, Fundación Hospital Alcorcón
  • Principal Investigator: Eulogio Conde, MD, Marqués de Valdecilla Hospital
  • Principal Investigator: José Javier Sánchez-Blanco, MD, Morales Meseguer Hospital
  • Principal Investigator: Concepción Nicolás, MD, Central de Asturias Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
ClinicalTrials.gov Identifier:
NCT01015248
Other Study ID Numbers:
  • MALT2008-01
  • No EudraCT: 2008-007725-39
First Posted:
Nov 18, 2009
Last Update Posted:
Sep 7, 2016
Last Verified:
Sep 1, 2016
Keywords provided by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
CD 20 positive
Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Rituximab
Bendamustine Hydrochloride

Study Results

No Results Posted as of Sep 7, 2016