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

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Collaborators: Hoffmann-La Roche; Lipomed
• Treatments: 2-chloro-3'-deoxyadenosine; Cladribine; Rituximab

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