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UnknownNCT00907348

Prospective Multicenter Dose Finding Phase II Pilot Trial to Evaluate Efficacy and Safety of LR-CHOP21 for Elderly Patients With Untreated Diffuse Large B Cell Lymphoma

Prospective Multicenter Dose Finding Phase II Pilot Trial to Evaluate Efficacy and Safety of Treatment With Lenalidomide Plus R-CHOP21 (LR-CHOP21) for Elderly Patients With Untreated Diffuse Large B Cell Lymphoma (DLBCL)

Status
Unknown
Phase
Phase 2
Study type
Interventional
Enrollment
49 (estimated)
Sponsor
Fondazione Italiana Linfomi - ETS · Academic / Other
Sex
All
Age
60 Years – 80 Years
Healthy volunteers
Not accepted

Summary

This is a prospective multicenter phase II pilot trial designed with the purpose of dose finding to evaluate the efficacy and safety of treatment with Lenalidomide plus R-CHOP21 (LR-CHOP21) for elderly patients with untreated Diffuse Large B Cell Lymphoma (DLBCL).

Conditions

Interventions

TypeNameDescription
DRUGLR-CHOP21FIRST DOSE LEVEL: Rituximab 375 mg/sqm D 0 or 1; Cyclophosphamide 750 mg/sqm iv D1; Doxorubicin 50 mg/sqm iv D1; Vincristine 1.4 mg/sqm iv D1; Prednisone 40 mg/sqm orally D1, D2, D3, D4, D5; Revlimid 5 mg/day D1-D14 SECOND DOSE LEVEL: Rituximab 375 mg/sqm D 0 or 1;Cyclophosphamide 750 mg/sqm iv D1; Doxorubicin 50 mg/sqm iv D1; Vincristine 1.4 mg/sqm iv D1; Prednisone 40 mg/sqm orally D1, D2, D3, D4, D5; Revlimid 10 mg/day D1-D14 THIRD DOSE LEVEL: Rituximab 375 mg/sqm D 0 or 1; Cyclophosphamide 750 mg/sqm iv D1; Doxorubicin 50 mg/sqm iv D1; Vincristine 1.4 mg/sqm iv D1; Prednisone 40 mg/sqm orally D1, D2, D3, D4, D5; Revlimid 15 mg/day D1-D14 FOURTH DOSE LEVEL: Rituximab 375 mg/sqm D 0 or 1; Cyclophosphamide 750 mg/sqm iv D1; Doxorubicin 50 mg/sqm iv D1; Vincristine 1.4 mg/sqm iv D1; Prednisone 40 mg/sqm orally D1, D2, D3, D4, D5; Revlimid 20 mg/day D1-D14 Repeated every 21 days

Timeline

Start date
2007-10-01
Primary completion
2009-10-01
Completion
2012-01-01
First posted
2009-05-22
Last updated
2011-10-13

Locations

18 sites across 1 country: Italy

Source: ClinicalTrials.gov record NCT00907348. Inclusion in this directory is not an endorsement.