CC-5013-NHL-008 MAGNIFY

Eine randomisierte Phase 3b Studie zur Erhaltungstherapie durch Kombination von Lenalidomid (CC-5013) und Rituximab und anschließender Monotherapie mit Lenalidomid oder Rituximab im Vergleich bei Patienten mit rezidiviertem/refraktärem follikulärem, Marginalzonen- oder Mantelzelllymphom

Status: aktiv

Patientenmerkmale

Einschlußkriterien

• Histologically confirmed
  • Follicular Lymphoma (Grade 1, 2 or 3a)
  • Marginal Zone Lymphoma
  • Mantle Cell Lymphoma
• Must have documented relapsed, refractory or Progressive Disease after last treatment with systemic therapy
• Bi-dimensionally measurable disease
• Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2
• Adequate bone marrow function
• Willingness to follow pregnancy precautions

Ausschlußkriterien

• Histology other than follicular or marginal zone lymphoma or clinical evidence of transformation or Grade 3b follicular lymphoma
• Any medical condition (other than the underlying lymphoma) that requires chronic steroid use
• Subjects taking corticosteroids during the last 1 week prior treatment, unless administered at a dose equivalent to < 20 mg/day of prednisone
• Systemic anti-lymphoma therapy within 28 days or use of antibody agents within 8 weeks use of radioimmunotherapy within 3 months
• Known seropositive for or active viral infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV)
• Known sensitivity or allergy to murine products
• Presence or history of central nervous system involvement by lymphoma.
• Subjects who are at a risk for a thromboembolic event and are not willing to take prophylaxis for it.
• Any condition that places the subject at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study

Studiendesign

Phase 3B, Prospektiv, Randomisiert, Multizentrisch

Intervention

• Lenalidomid + Rituximab, gefolgt von Rituximab-Lenalidomid-Erhaltungstherapie
  
  vs.
• Lenalidomid + Rituximab, gefolgt von Rituximab-Erhaltungstherapie

Zuständigkeiten

Sponsor

Celgene Corporation
86 Morris Avenue
Summit, NJ 07901
USA

Studienkontakt

Paula Franson
Celgene Corporation
86 Morris Avenue
Summit, NJ 07901
USA
Email: pfranson@celgene.com

Kontakt

Gudrun Biemer-Mansouri

Telefon: +49 (0)641-985-42-602
Telefax: +49 (0)641-985-42-609
Email: gudrun.biemer-mansouri@innere.med.uni-giessen.de

Yvonne Holderer

Telefon: +49 (0)641-985-42-602
Telefax: +49 (0)641-985-42-609
Email: yvonne.holderer@innere.med.uni-giessen.de