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

December 23, 2013 updated by: Arbeitsgemeinschaft medikamentoese Tumortherapie

Phase II Trial of Rituximab Plus 2CdA in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)

The purpose of this trial is to evaluate whether a Rituximab plus 2 CdA combination therapy is effective and safe in the treatment of patients with advanced or relapsed lymphoma of the mucosa associated lymphoid tissue (MALT).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Currently, there is no chemotherapeutic standard treatment for patients with MALT lymphoma either presenting with disseminated disease or with relapsing/refractory disease following local treatment (including radiation) or eradication of HP. Various compounds have been tested, including alkylating agents such as cyclophosphamide or chlorambucil, the nucleoside analog cladribine (2CdA), as well as combination regimens including CHOP or MCP (mitoxantrone, chlorambucil, prednisone), but only limited data exists from prospective trials. Thus, trials to evaluate the potential of new compounds in patients with advanced MALT lymphoma are not only justified, but seem warranted.

While systemic approaches were until recently thought to be justified only in patients with disseminated disease, emerging data suggest that also patients with localized disease potentially amenable to radiation may benefit from systemic treatment. This has been demonstrated for ocular adnexal MALT lymphoma and recently also for gastric MALT lymphoma in a randomized fashion, where application of chemotherapy resulted in a significantly longer time to relapse as opposed to surgery or radiation without impairing overall survival.

Both 2CdA and rituximab have been demonstrated as active single agents in MALT lymphoma with mild toxicity profiles and no data on combination therapy with rituximab plus chemotherapy in MALT lymphoma have been published to date. This study will therefore evaluate the efficacy and safety of Rituximab plus 2CdA in patients with advanced or relapsed lymphoma of the mucose associated lymphoid tissue.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, A-8036
        • Universitätsklinikum Graz
      • Innsbruck, Austria, A-6020
        • Universitaetsklinik Innsbruck/ Klinik für Innere Medizin
      • Linz, Austria, A-4020
        • Krankenhaus der Stadt Linz
      • Salzburg, Austria, A-5020
        • Universitaetsklinik f. Innere Medizin III
      • Vienna, Austria, A-1090
        • AKH Wien / Universitaetsklinik fuer Innere Medizin I

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • Measurable disease
  • ECOG performance status of 0,1 or 2
  • Age at least 18 years
  • Life expectancy of at least 3 months
  • Adequate cardiac, renal and liver function tests (LVEF > 50%, serum creatinine < 2.5 mg/dl, ALAT or ASAT < 2.5 x upper limit of normal range (ULN), alkaline phosphatase < 2.5 x ULN, serum bilirubin < 2.0 mg/dl)
  • Patient must be willing and able to comply with the protocol for the entire study duration
  • Women of child-bearing potential must have a negative pregnancy test and must agree to use effective contraception for the entire treatment period
  • Patient's written informed consent

Exclusion Criteria:

  • Lymphoma histology other than MALT lymphoma or MALT lymphoma transforming to diffuse large cell lymphoma ("high grade lymphoma")
  • Use of any investigational agent 30 days prior to inclusion
  • History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years
  • Major surgery, other than diagnostic surgery, within the last 4 weeks
  • Evidence of CNS involvement
  • A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
  • Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months
  • Inadequate hematological status at baseline prior to study entry: Dependency on red blood cell and/or platelet transfusions, ANC (absolute neutrophile count (segmented + bands) <1.0 x 109/L
  • Patients with active opportunistic infections
  • Pregnant or breast feeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment Arm
Combination therapy Rituximab plus 2CdA
Drug: Rituximab
375 mg/m2 on day 1 of a 21-day treatment cycle
Other Names:
  • MabThera
Drug: 2-CdA
0.1 mg/kg s.c. on days 1 - 4 of a 21-day treatment cycle
Other Names:
  • Litak

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: After 2, 4 and 6 cycles of therapy
After 2, 4 and 6 cycles of therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival and relapse-free survival
Time Frame: Duration of study
Duration of study
Occurrence of adverse events
Time Frame: Duration of study
Duration of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Collaborators

Hoffmann-La Roche
Lipomed

Investigators

  • Principal Investigator: Markus Raderer, Prof. Dr., AKH Wien / Universitaetsklinik fuer Innere Medizin I

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

April 2, 2008

First Submitted That Met QC Criteria

April 10, 2008

First Posted (ESTIMATE)

April 11, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 24, 2013

Last Update Submitted That Met QC Criteria

December 23, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGMT_MALT
  • EudraCT 2008-000767-41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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