Status:
COMPLETED
Rituximab Plus 2CdA in Patients With Advanced or Relapsed Mucosa Associated Lymphoid Tissue (MALT) Lymphoma
Lead Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborating Sponsors:
Hoffmann-La Roche
Lipomed
Conditions:
Lymphoma of Mucosa-Associated Lymphoid Tissue
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 associat...
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 (i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00656812
Start Date
May 1 2008
End Date
September 1 2011
Last Update
December 24 2013
Active Locations (5)
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1
Universitätsklinikum Graz
Graz, Austria, A-8036
2
Universitaetsklinik Innsbruck/ Klinik für Innere Medizin
Innsbruck, Austria, A-6020
3
Krankenhaus der Stadt Linz
Linz, Austria, A-4020
4
Universitaetsklinik f. Innere Medizin III
Salzburg, Austria, A-5020