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

NCT00656812 | Completed Phase 2

• 2 other identifiers: AGMT_MALTEudraCT 2008-000767-41
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

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).

Conditions

Lymphoma of Mucosa-Associated Lymphoid Tissue

Keywords

advanced MALT lymphoma; Rituximab; 2CdA; chemotherapy; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Response rate

  After 2, 4 and 6 cycles of therapy

Secondary Outcomes (2)

• Progression-free survival and relapse-free survival

  Duration of study

• Occurrence of adverse events

  Duration of study

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Combination therapy Rituximab plus 2CdA

Drug: Rituximab; Drug: 2-CdA

Interventions

Rituximab DRUG

375 mg/m2 on day 1 of a 21-day treatment cycle

Also known as: MabThera

Treatment Arm

2-CdA DRUG

0.1 mg/kg s.c. on days 1 - 4 of a 21-day treatment cycle

Also known as: Litak

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Lymphoma histology other than MALT lymphoma or MALT lymphoma transforming to diffuse large cell lymphoma ("high grade lymphoma")
• 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

Sponsors & Collaborators

• Arbeitsgemeinschaft medikamentoese Tumortherapie: lead
• Hoffmann-La Roche: collaborator
• Lipomed: collaborator

Study Sites (5)

Universitätsklinikum Graz

Graz, A-8036, Austria

Location

Universitaetsklinik Innsbruck/ Klinik für Innere Medizin

Innsbruck, A-6020, Austria

Location

Krankenhaus der Stadt Linz

Linz, A-4020, Austria

Location

Universitaetsklinik f. Innere Medizin III

Salzburg, A-5020, Austria

Location

AKH Wien / Universitaetsklinik fuer Innere Medizin I

Vienna, A-1090, Austria

Location

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

Rituximab; Cladribine

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; 2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Markus Raderer, Prof. Dr.

  AKH Wien / Universitaetsklinik fuer Innere Medizin I

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: April 11, 2008
• Study Start: May 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 24, 2013

Record last verified: 2013-12

Locations

AU (5)