Tedavi Edilmemiş ABC Tipi Diffüz Büyük B Hücreli Lenfomada Lenalidomid + R-CHOP Kemoterapisinin Plasebo + R-CHOP'a Karşı Etkinlik ve Güvenliği

Sade dilde özet

Bu çalışma, yeni tanı almış, tedavi edilmemiş aktive B hücreli (ABC) tip diffüz büyük B hücreli lenfoma (diffuse large B-cell lymphoma) hastalarında Lenalidomid + R-CHOP kemoterapisini, plasebo + R-CHOP ile karşılaştırıyor. Doğrulanmış ABC tip DLBCL olan 18-80 yaş arası hastalar dahil edilmiştir. Faz 3 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 3 (Phase 3)

Durum

Tamamlandı

Sponsor

Celgene

Müdahale

lenalidomide, Placebo, Rituximab, Cyclophosphamide, Doxorubicin, prednisone, vincristine

Başlangıç

17.02.2015

Tahmini bitiş

28.07.2022

Ülkeler

United States, Australia, Belgium, Canada, China, Czechia, France, Ireland, Israel, Italy, Japan, Netherlands, New Zealand, Portugal, Puerto Rico, Russia, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye)

İlgili genler

Merkezler

• Fayetteville, United States
• Orange, United States
• Sacramento, United States
• New Haven, United States
• Hollywood, United States
• Ames, United States
• Sioux City, United States
• Fairway, United States
• Shreveport, United States
• Bethesda, United States
• Minneapolis, United States
• Minneapolis, United States
• Rochester, United States
• Durham, United States
• Philadelphia, United States
• Dallas, United States
• Dallas, United States
• Salt Lake City, United States
• Edmonds, United States
• Issaquah, United States
• Seattle, United States
• Seattle, United States
• Albury, Australia
• Clayton, Australia
• Geelong, Australia
• Frankston, Australia
• Brussels, Belgium
• Liège, Belgium
• Roeselare, Belgium
• Sint-Niklaas, Belgium
• Calgary, Canada
• Surrey, Canada
• Saint John, Canada
• Greenfield Park, Canada
• Montreal, Canada
• Beijing, China
• Beijing, China
• Beijing, China
• Beijing, China
• Changchun, China

+118

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

1. Histologically proven Diffuse Large B-Cell Lymphoma of the Activated B-Cell type
2. Newly diagnosed, previously untreated Diffuse Large B-Cell Lymphoma
3. Measurable Diffuse Large B-Cell Lymphoma disease by Computed Tomography (CT) / Magnetic Resonance Imagining (MRI) scans
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
5. Age 18 - 80 years; age \> 80 allowed at investigator discretion if performance status ≤ 1; and each organ system score ≤ 2 using cumulative illness rating scale (CIRS)

Exclusion Criteria:

1. Diagnosis of lymphoma histologies other than Diffuse Large B-Cell Lymphoma
2. History of malignancies, other than Diffuse Large B-Cell Lymphoma, unless the patient has been disease free for 5 years or more
3. Known seropositive for, or history of, active Human Immunodeficiency Virus (HIV) Hepatitis B Virus (HBV), Hepatitis C Virus (HCV)
4. Contraindication to any drug in the chemotherapy regimen, and specifically: LVEF (Left Ventricular Ejection Fraction) \< 45% or peripheral neuropathy grade 2