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

Primary Purpose

Lymphoma of Mucosa-Associated Lymphoid Tissue

Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Rituximab
2-CdA
Sponsored by
Arbeitsgemeinschaft medikamentoese Tumortherapie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma of Mucosa-Associated Lymphoid Tissue focused on measuring advanced MALT lymphoma, Rituximab, 2CdA, chemotherapy, immunotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsklinikum Graz
  • Universitaetsklinik Innsbruck/ Klinik für Innere Medizin
  • Krankenhaus der Stadt Linz
  • Universitaetsklinik f. Innere Medizin III
  • AKH Wien / Universitaetsklinik fuer Innere Medizin I

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

Combination therapy Rituximab plus 2CdA

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

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

Full Information

First Posted
April 2, 2008
Last Updated
December 23, 2013
Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators
Hoffmann-La Roche, Lipomed
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1. Study Identification

Unique Protocol Identification Number
NCT00656812
Brief Title
Rituximab Plus 2CdA in Patients With Advanced or Relapsed Mucosa Associated Lymphoid Tissue (MALT) Lymphoma
Official Title
Phase II Trial of Rituximab Plus 2CdA in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators
Hoffmann-La Roche, Lipomed

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma of Mucosa-Associated Lymphoid Tissue
Keywords
advanced MALT lymphoma, Rituximab, 2CdA, chemotherapy, immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Combination therapy Rituximab plus 2CdA
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
MabThera
Intervention Description
375 mg/m2 on day 1 of a 21-day treatment cycle
Intervention Type
Drug
Intervention Name(s)
2-CdA
Other Intervention Name(s)
Litak
Intervention Description
0.1 mg/kg s.c. on days 1 - 4 of a 21-day treatment cycle
Primary Outcome Measure Information:
Title
Response rate
Time Frame
After 2, 4 and 6 cycles of therapy
Secondary Outcome Measure Information:
Title
Progression-free survival and relapse-free survival
Time Frame
Duration of study
Title
Occurrence of adverse events
Time Frame
Duration of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Raderer, Prof. Dr.
Organizational Affiliation
AKH Wien / Universitaetsklinik fuer Innere Medizin I
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Graz
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
Facility Name
Universitaetsklinik Innsbruck/ Klinik für Innere Medizin
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Krankenhaus der Stadt Linz
City
Linz
ZIP/Postal Code
A-4020
Country
Austria
Facility Name
Universitaetsklinik f. Innere Medizin III
City
Salzburg
ZIP/Postal Code
A-5020
Country
Austria
Facility Name
AKH Wien / Universitaetsklinik fuer Innere Medizin I
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

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