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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00656812
Recruitment Status : Completed
First Posted : April 11, 2008
Last Update Posted : December 24, 2013
Hoffmann-La Roche
Information provided by:
Arbeitsgemeinschaft medikamentoese Tumortherapie

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Lymphoma of Mucosa-Associated Lymphoid Tissue Drug: Rituximab Drug: 2-CdA Phase 2

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Rituximab Plus 2CdA in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
Study Start Date : May 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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 Name: MabThera

Drug: 2-CdA
0.1 mg/kg s.c. on days 1 - 4 of a 21-day treatment cycle
Other Name: Litak

Primary Outcome Measures :
  1. Response rate [ Time Frame: After 2, 4 and 6 cycles of therapy ]

Secondary Outcome Measures :
  1. Progression-free survival and relapse-free survival [ Time Frame: Duration of study ]
  2. Occurrence of adverse events [ Time Frame: Duration of study ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00656812

Universitätsklinikum Graz
Graz, Austria, A-8036
Universitaetsklinik Innsbruck/ Klinik für Innere Medizin
Innsbruck, Austria, A-6020
Krankenhaus der Stadt Linz
Linz, Austria, A-4020
Universitaetsklinik f. Innere Medizin III
Salzburg, Austria, A-5020
AKH Wien / Universitaetsklinik fuer Innere Medizin I
Vienna, Austria, A-1090
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Hoffmann-La Roche
Principal Investigator: Markus Raderer, Prof. Dr. AKH Wien / Universitaetsklinik fuer Innere Medizin I

Responsible Party: Prof. Dr. Richard Greil, Arbeitsgemeinschaft medikamentoese Tumortherapie Identifier: NCT00656812     History of Changes
Other Study ID Numbers: AGMT_MALT
EudraCT 2008-000767-41
First Posted: April 11, 2008    Key Record Dates
Last Update Posted: December 24, 2013
Last Verified: December 2013

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
advanced MALT lymphoma

Additional relevant MeSH terms:
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents