Ofatumumab With IVAC Salvage Chemotherapy in Diffuse Large B Cell Lymphoma Patients
NCT ID: NCT01481272
Last Updated: 2021-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
77 participants
INTERVENTIONAL
2011-11-30
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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O-IVAC
Ofatumumab Etoposide Ifosfamide Mesna Cytarabine Methotrexate Leukovorin Granulocyte-Colony Stimulating Factor
Ofatumumab
1000 IV, according to detailed instruction included in the protocol, on day 1 of each 21-day cycle, maximum 6 cycles
Etoposide
60mg/m2 IV, daily over 1 hour, on days 1-5 of 21-day cycle, maximum 6 cycles
Ifosfamid
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
Mesna
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
Cytarabine
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
Methotrexate
12mg, it, on day 5 of each 21 days cycle, maximum 6 cycles
Leukovorin
15mg, po 24 hours after methotrexate it
Granulocyte-Colony Stimulating Factor
5 microgram/kg or 263 microgram ampoule, sc, daily, starting on day 7 of each 21 day cycle, until ANC\>1.0x109/l
Interventions
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Ofatumumab
1000 IV, according to detailed instruction included in the protocol, on day 1 of each 21-day cycle, maximum 6 cycles
Etoposide
60mg/m2 IV, daily over 1 hour, on days 1-5 of 21-day cycle, maximum 6 cycles
Ifosfamid
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
Mesna
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
Cytarabine
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
Methotrexate
12mg, it, on day 5 of each 21 days cycle, maximum 6 cycles
Leukovorin
15mg, po 24 hours after methotrexate it
Granulocyte-Colony Stimulating Factor
5 microgram/kg or 263 microgram ampoule, sc, daily, starting on day 7 of each 21 day cycle, until ANC\>1.0x109/l
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Progressing or relapsed following prior treatment including but not limited to rituximab-CHOP chemotherapy regimen.
* Not suitable for ASCT (age \> 60 years, PS ≥ 2, prior ASCT as a part of the previous treatment for DLBCL, and/or other medical conditions that unable the patients to undergo the ASCT, e.g. NYHA II, creatinine clearance \< 50 mL/min).
* Age ≥ 18 years.
* ECOG/ WHO performance status grades 0 - 3.
* Resolution of toxicities from previous therapy to grade ≤ 1.
* Written signed and dated informed consent prior to any study procedures being performed.
Exclusion Criteria
* Prior treatment with anti-CD20 monoclonal antibodies with the exception of rituximab.
* Screening laboratory values:
* platelets \< 75 x 109/L (unless due to DLBCL involvement of the bone marrow),
* neutrophils \< 1.5 x 109/L (unless due to DLBCL involvement of the bone marrow),
* creatinine \> 2.0 times upper normal limit (unless normal creatinine clearance),
* total bilirubin \>1.5 times upper normal limit (unless due to DLBCL involvement of liver or a known history of Gilbert's disease),
* ALT \> 2.5 times upper normal limit (unless due to DLBCL involvement of liver),
* alkaline phosphatase \> 2.5 times upper normal limit (unless due to DLBCL involvement of the liver or bone marrow).
* Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
* Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrolment, whichever is longer, or currently participating in any other interventional clinical study.
* Other past or current malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
* Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis C.
* History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequel.
* Known HIV positive.
* Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (NYHA III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities.
* Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient.
* Positive serology for Hepatitis B (HB).
* Positive serology for hepatitis C (HC).
* Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test at screening.
* Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy.
* Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy.
* Patients unwilling or unable to comply with the protocol.
18 Years
ALL
No
Sponsors
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Polish Lymphoma Research Group
NETWORK
Responsible Party
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Principal Investigators
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Jan Walewski, Prof.
Role: STUDY_CHAIR
CENTRUM ONKOLOGII - INSTYTUT im. Marii Skłodowskiej-Curie ul. W.K. Roentgena 5, 02-781 Warszawa
Krzysztof Warzocha, Prof.
Role: PRINCIPAL_INVESTIGATOR
Instytut Hematologii i Transfuzjologii, 02-776 Warszawa ul. Indiry Gandhi 14
Andrzej Hellmann, Prof.
Role: PRINCIPAL_INVESTIGATOR
Klinika Hematologii i Tranplantologii, Uniwersyteckie Centrum Medyczne, ul. Dębinki 7, 80-952 Gdańsk
Andrzej Pluta, Prof.
Role: PRINCIPAL_INVESTIGATOR
Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. ks. Bronisława Markiewicza, ul. ks. Bielawskiego 18, 36-200 Brzozów
Andrzej Lange, Prof.
Role: PRINCIPAL_INVESTIGATOR
Dolnośląskie Centrum Transplantacji Komórkowych, 53-439 Wrocław, ul. Grabiszyńska105
Wanda Knopinska-Posluszny, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Oddz. Hematologii, Samodzielny Publiczny ZOZ MSW z Warminsko-Mazurskim Centrum Onkologii w Olsztynie; ul.Wojska Polskiego 37, 10-228 Olsztyn
Sebastian Giebel, Prof.
Role: PRINCIPAL_INVESTIGATOR
Klinika Transplantacji Szpiku i Onkohematologii, Centrum Onkologii Instytut im. M. Sklodowskiej-Curie w Gliwicach; al. Wybrzeże Armii Krajowej 15, 44-101 Gliwice
Jan M Zaucha, Prof.
Role: PRINCIPAL_INVESTIGATOR
Oddz. Onkologii i Radioterapii, Szpital Morski im. PCK; ul. Powstania Styczniowego 1, 81-519 Gdynia
Locations
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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
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
Countries
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Other Identifiers
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2010-023568-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PLRG8 (OMB114361)
Identifier Type: -
Identifier Source: org_study_id