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

This study has been completed.
Sponsor:
Collaborators:
Hoffmann-La Roche
Lipomed
Information provided by:
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT00656812
First received: April 2, 2008
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Lymphoma of Mucosa-Associated Lymphoid Tissue
Drug: Rituximab
Drug: 2-CdA
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

Primary Outcome Measures:
  • Response rate [ Time Frame: After 2, 4 and 6 cycles of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival and relapse-free survival [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  • Occurrence of adverse events [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: May 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00656812

Locations
Austria
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
Lipomed
Investigators
Principal Investigator: Markus Raderer, Prof. Dr. AKH Wien / Universitaetsklinik fuer Innere Medizin I
  More Information

No publications provided

Responsible Party: Prof. Dr. Richard Greil, Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT00656812     History of Changes
Other Study ID Numbers: AGMT_MALT, EudraCT 2008-000767-41
Study First Received: April 2, 2008
Last Updated: December 23, 2013
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
advanced MALT lymphoma
Rituximab
2CdA
chemotherapy
immunotherapy

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
2-chloro-3'-deoxyadenosine
Rituximab
Cladribine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 23, 2014