Clinical trial · Interventional
Rituximab Plus 2CdA in Patients With Advanced or Relapsed Mucosa Associated Lymphoid Tissue (MALT) Lymphoma
Phase II Trial of Rituximab Plus 2CdA in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
NCT00656812CI-TRIAL-00013230completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma of Mucosa-Associated Lymphoid Tissue | Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2-CdA | Drug | Cladribine | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- description
- Combination therapy Rituximab plus 2CdA
- interventionNames
- Drug: Rituximab
- Drug: 2-CdA
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- After 2, 4 and 6 cycles of therapy
Secondary outcomes (2)
- measure
- Progression-free survival and relapse-free survival
- timeFrame
- Duration of study
- measure
- Occurrence of adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 womenReferences
Publications (0)
Data not yet available
No reference posted for this study.