Phase 2
N=48
Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue
Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
Bottom Line
View on ClinicalTrials.gov: NCT01611259 ↗Enrolled (actual)
48
Serious AEs
37.5%
Results posted
Nov 2017
Primary outcome: Primary: Objective Responses in Patients With MALT Lymphoma Presenting With Measureable Disease — 25; 20; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rituximab and Lenalidomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Arbeitsgemeinschaft medikamentoese Tumortherapie
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Responses in Patients With MALT Lymphoma Presenting With Measureable Disease |
25; 20; 1 | — |
| SECONDARY Number and Severity of Adverse Events |
— | — |
| SECONDARY Influence of Rituximab Plus Lenalidomide on T-cell Subsets |
— | — |
Summary
This is an open label, phase II study to evaluate the capacity of Rituximab (Mabthera®) plus Lenalidomide (Revlimid®) to induce objective responses in patients with Mucosa Associated Lymphoid Tissue (MALT) lymphoma presenting with measurable disease.
Eligibility Criteria
Inclusion Criteria selected:
- Histologically verified diagnosis if MALT lymphoma of any localization
- Measurable disease upon diagnosis or first or greater relapse after local therapy, prior chemotherapy orHP-eradication. In addition, also in patients with gastric MALT-lymphoma judged refractory to HP-eradication by a minimum follow-up of 12 months after successfulHP-eradication will be included in the study. Patients with gastric MALT lymphoma and no evidence of HP-infection may be enrolled immediately
- Ann Arbor Stage I-IV
- In case of prior treatment with Rituximab, the presence of CD20 on lymphoma cells must have been demonstrated before inclusion in the trial.
- ECOG performance status of 0, 1 or 2
- Patient must be able to take aspirin daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin
Exclusion Criteria selected:
- Lymphoma histology other than MALT lymphoma or MALT lymphoma with a diffuse large cell lymphoma ("high grade lymphoma") - component
- Use of any investigational agent within 28 days prior to initiation of treatment with lenalidomide
- 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
- Severe peripheral polyneuropathy
- Clinically significant cardiac disease or myocardial infarction within the last 6 months
- Known hypersensitivity to thalidomide or lenalidomide or rituximab
Data sourced from ClinicalTrials.gov (NCT01611259). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.