Trials Sponsors Conditions Drugs Pricing

Conditions

Lymphoma of Mucosa-Associated Lymphoid Tissue

Keywords

advanced MALT lymphomaRituximab2CdAchemotherapyimmunotherapy

Outcome Measures

Primary Outcomes (1)

Response rate
After 2, 4 and 6 cycles of therapy

Secondary Outcomes (2)

Progression-free survival and relapse-free survival
Duration of study
Occurrence of adverse events
Duration of study

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Combination therapy Rituximab plus 2CdA

Drug: RituximabDrug: 2-CdA

Interventions

RituximabDrug

375 mg/m2 on day 1 of a 21-day treatment cycle

Also known as: MabThera

Treatment Arm

2-CdADrug

0.1 mg/kg s.c. on days 1 - 4 of a 21-day treatment cycle

Also known as: Litak

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Histologically proven diagnosis of MALT lymphoma of any localization
Disseminated disease upon diagnosis in case of gastric lymphoma or first or greater relapse after local therapy (including gastrectomy or surgery), prior chemotherapy or HP-eradication. In addition, also patients with localized gastric lymphoma judged refractory to HP-eradication by a minimum follow-up of 12 months after successful HP-eradication can be included in the study.

Sponsors & Collaborators

Lipomed
Industrycollaborator
Arbeitsgemeinschaft medikamentoese Tumortherapie
Otherlead
Hoffmann-La Roche

Study Sites (5)

Universitätsklinikum Graz

Graz, A-8036, Austria

Universitaetsklinik Innsbruck/ Klinik für Innere Medizin

Innsbruck, A-6020, Austria

Krankenhaus der Stadt Linz

Linz, A-4020, Austria

Universitaetsklinik f. Innere Medizin III

Salzburg, A-5020, Austria

AKH Wien / Universitaetsklinik fuer Innere Medizin I

Vienna, A-1090, Austria

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

RituximabCladribine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Study Officials

Markus Raderer, Prof. Dr.
AKH Wien / Universitaetsklinik fuer Innere Medizin I
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER

Study Record Dates

First Submitted

April 2, 2008

First Posted

April 11, 2008

Study Start

May 2008

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2011

Actual (reported)

Rituximab Plus 2CdA in Patients With Advanced or Relapsed Mucosa Associated Lymphoid Tissue (MALT) Lymphoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Treatment Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Treatment Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations