NCT01611259

Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue

Phase II Trial of Rituximab Plus Lenalidomide in Patients With Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)

Interventions

Type	Name	Description
DRUG	Rituximab and Lenalidomide	Rituximab 375 mg/m² i.v. day 1 Lenalidomide 20 mg p.o. daily for 21 days Cycles should be repeated every 28 days. Restaging should be performed after three cycles. In case of at least stable disease, patients should receive another three courses of therapy. Patients with documented CR after 6 courses will stop therapy/study, while patients with PR or SD will be given another two cycles for a maximum of 8 cycles.

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-05-01
• Completion: 2015-02-01
• First posted: 2012-06-04
• Last updated: 2017-11-06
• Results posted: 2017-11-06

Locations

5 sites across 1 country: Austria