Trials Sponsors Conditions Drugs Pricing

Conditions

Lymphoma, Mucosa-Associated Lymphoid Tissue

Outcome Measures

Primary Outcomes (1)

Event-free-survival (EFS)
Percentage of patients without events (failure of treatment or Death from any cause) after 5 years from trial registration
5 years

Secondary Outcomes (4)

Complete and Partial Remission Rate - Percentage of Patients With Complete and Partial Response at the End of Treatment
End of treatment (after 24 weeks of therapy)
Response Duration (Time to Relapse or Progression) - Percentage of Patients in Continuous Remission at Five Years From Trial Registration
5 years
Progression-free-survival (PFS)
5 years
Overall Survival
5 years

Study Arms (3)

ARM A

ACTIVE COMPARATOR

chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment; two weeks rest; chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)

Drug: chlorambucil (drug)

ARM B

EXPERIMENTAL

rituximab 375 mg/m2 iv, d1, d8, d15, d22 chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle

Drug: rituximab+chlorambucil

ARM C (Since April 2006)

EXPERIMENTAL

Interventions

chlorambucil (drug)Drug

chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment, two weeks rest, chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)

ARM A

rituximab+chlorambucilDrug

rituximab 375 mg/m2 iv, d1, 8, 15, 22, chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment, ; two weeks rest; chlorambucil 6 mg/m2 os, daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
rituximab+chlorambucil
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site
any stage (Ann Arbor I-IV)

Sponsors & Collaborators

International Extranodal Lymphoma Study Group (IELSG)
Otherlead

Study Sites (75)

ACZA Campus Stuivenberg

Antwerp, Belgium

AZ StJan

Bruges, Belgium

St Luc

Brussels, Belgium

ULB Hopital Erasme

Brussels, Belgium

CHNDRF

Charleroi, Belgium

Hospital St Joseph

Gilly, Belgium

UCL de Mont Godinne

Yvoir, Belgium

Centre Hospitalier de Blois

Related Publications (2)

Bommier C, Zucca E, Chevret S, Conconi A, Nowakowski G, Maurer MJ, Cerhan JR, Thieblemont C, Lambert J. Early complete response as a validated surrogate marker in extranodal marginal zone lymphoma systemic therapy. Blood. 2024 Feb 1;143(5):422-428. doi: 10.1182/blood.2023020984.
PMID: 37801707DERIVED
Zucca E, Conconi A, Laszlo D, Lopez-Guillermo A, Bouabdallah R, Coiffier B, Sebban C, Jardin F, Vitolo U, Morschhauser F, Pileri SA, Copie-Bergman C, Campo E, Jack A, Floriani I, Johnson P, Martelli M, Cavalli F, Martinelli G, Thieblemont C. Addition of rituximab to chlorambucil produces superior event-free survival in the treatment of patients with extranodal marginal-zone B-cell lymphoma: 5-year analysis of the IELSG-19 Randomized Study. J Clin Oncol. 2013 Feb 10;31(5):565-72. doi: 10.1200/JCO.2011.40.6272. Epub 2013 Jan 7.
PMID: 23295789

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

ChlorambucilPharmaceutical PreparationsRituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Results Point of Contact

Title: Prof. Emanuele Zucca MD, Scientific and Medical Director
Organization: International Extranodal Lymphoma Study Group (IELSG)

Study Officials

Emanuele Zucca, MD
International Extranodal Lymphoma Study Group/Oncology Institute of Southern Switzerland. Bellinzona
STUDY CHAIR
Emilio Montserrat, MD
Clinic Hospital Universitari, Hematology. Barcelona
STUDY CHAIR
Catherine Thieblemont, MD
Centre Hospitalier Lyon Sud, Hematology. Lyon
STUDY CHAIR
Giovanni Martinelli, MD
Hemato-oncology. European Oncology Institute. Milan
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

454 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

January 2003

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (3)

ARM A

ARM B

ARM C (Since April 2006)

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (75)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Named ingredients in these interventions

Intervention Hierarchy (Ancestors)

Source record

Locations