Spots Global Cancer Trial Database for Ofatumumab With IVAC Salvage Chemotherapy in Diffuse Large B Cell Lymphoma Patients

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Trial Identification

Brief Title: Ofatumumab With IVAC Salvage Chemotherapy in Diffuse Large B Cell Lymphoma Patients

Official Title: A Phase II Trial on Ofatumumab With IVAC Salvage Chemotherapy in Diffuse Large B Cell Lymphoma Patients Progressing or Relapsed After Prior R-CHOP Treatment Not Suitable for Autologous Stem Cell Transplant

Study ID: NCT01481272

Conditions

Diffuse Large B Cell Lymphoma

Interventions

Granulocyte-Colony Stimulating Factor

Study Description

Brief Summary: It is expected that addition of anti-CD20 antibody - ofatumumab would enhance the activity of the etoposide+ifosphamide with mesna+cytarabine+methotrexate+lenograstim or filgrastim (IVAC) regimen. This study is planned to determine the efficacy and safety of ofatumumab in combination with IVAC chemotherapy in patients with CD20 positive diffuse large B cell lymphoma progressing or relapsed after prior R-CHOP chemotherapy not suitable for Autologous Stem Cell Transplant (ASCT).

Detailed Description: The purpose of this study is to assess the Overall Response Rate (ORR) = Complete Response (CR) + Partial Response (PR) in adult Diffuse Large B Cell Lymphoma (DLBCL) patients progressing or relapsed after prior R-CHOP treatment not suitable for ASCT treated with O-IVAC salvage chemotherapy regimen. The secondary objective is the evaluation of progression-free survival (PFS), event-free survival (EFS), overall survival (OS), safety and tolerability.

Keywords

Salvage therapy in DLBCL

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Dolnośląskie Centrum Transplantacji Komórkowych, Wrocław, Dolnośląskie, Poland

Instytut Hematologii i Transfuzjologii, Warszawa, Mazowieckie, Poland

Centrum Onkologii - Istytut im. M.Sklodowskiej-Curie, Warszawa, Mazowieckie, Poland

Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. ks. Bronisława Markiewicza, Brzozów, Podkarpackie, Poland

Uniwersyteckie Cenrum Medyczne, Gdańsk, Pomorskie, Poland

Szpital Morski im. PCK Oddz. Onkologii i Radioterapii, Gdynia, Pomorskie, Poland

Klinika Transplantacji Szpiku i Onkohematologii; Centrum Onkologii Instytut im. M.Sklodowskiej-Curie, Oddz. w Gliwicach, Gliwice, Slaskie, Poland

Oddz. Hematologii, Samodzielny Publiczny ZOZ MSW z Warminsko-Mazurskim Centrum Onkologii w Olsztynie, Olsztyn, Warminsko-Mazurskie, Poland

Contact Details

Name: Jan Walewski, Prof.

Affiliation: CENTRUM ONKOLOGII - INSTYTUT im. Marii Skłodowskiej-Curie ul. W.K. Roentgena 5, 02-781 Warszawa

Role: STUDY_CHAIR

Name: Krzysztof Warzocha, Prof.

Affiliation: Instytut Hematologii i Transfuzjologii, 02-776 Warszawa ul. Indiry Gandhi 14