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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
77
1000 IV, according to detailed instruction included in the protocol, on day 1 of each 21-day cycle, maximum 6 cycles
60mg/m2 IV, daily over 1 hour, on days 1-5 of 21-day cycle, maximum 6 cycles
1500mg/m2 or 1000mg/m2 (patients \>/=60 years), IV, daily over 1 hour, on 1-5 days of each 21-day cycle, maximum 6 cycles
Dolnośląskie Centrum Transplantacji Komórkowych
Wroclaw, Lower Silesian Voivodeship, Poland
Instytut Hematologii i Transfuzjologii
Warsaw, Masovian Voivodeship, Poland
Centrum Onkologii - Istytut im. M.Sklodowskiej-Curie
Warsaw, Masovian Voivodeship, Poland
Response rate
Complete response + partial response
Time frame: 12 months post-therapy
Progression-free survival
Staying free of disease progression
Time frame: 12 month post-therapy
Event-free survival
Staying free of event such as disease progression, relapse, death, starting new anticancer therapy, patient's refusal to continue study treatment, Serious Adverse Event that causes discontinuation of study treatment
Time frame: 12 month post-therapy
Overall survival
Time since entering the study till death of any reason
Time frame: 12 months post-therapy
Number of participants with adverse events as a measure of safety and tolerability
Reporting Adverse Events and Serious Adverse Events
Time frame: 12 months post-therapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
300mg/m2 or 200mg/m2 (patients \>/=60 years), IV, over 1 hour, mixed with ifosfamid then 900mg/m2 or 600mg/m2 (patients \>/=60 years)over 12 hour or by local practice, on 1-5 days of each 21 day cycle, maximum 6 cycles
2g/m2 or 0,5-1g/m2 (patients \>/= 60 years), IV, over 3 hours, 12 hourly (total of 4 doses), on days 1-2 of each 21 day cycle, maximum 6 cycles
12mg, it, on day 5 of each 21 days cycle, maximum 6 cycles
15mg, po 24 hours after methotrexate it
5 microgram/kg or 263 microgram ampoule, sc, daily, starting on day 7 of each 21 day cycle, until ANC\>1.0x109/l
Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. ks. Bronisława Markiewicza
Brzozów, Podkarpackie Voivodeship, Poland
Uniwersyteckie Cenrum Medyczne
Gdansk, Pomeranian Voivodeship, Poland
Szpital Morski im. PCK Oddz. Onkologii i Radioterapii
Gdynia, Pomeranian Voivodeship, Poland
Klinika Transplantacji Szpiku i Onkohematologii; Centrum Onkologii Instytut im. M.Sklodowskiej-Curie, Oddz. w Gliwicach
Gliwice, Silesian Voivodeship, Poland
Oddz. Hematologii, Samodzielny Publiczny ZOZ MSW z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, Warmian-Masurian Voivodeship, Poland