MabionCD20 Compared to MabThera in Lymphoma Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

143

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

August 31, 2017

Study Completion Date

January 31, 2018

Conditions
Diffuse Large B-Cell Lymphoma
Interventions
DRUG

Rituximab

375 mg/m2 IV on day 1 of each 21 days chemotherapy cycle. Number of Cycles: 8.

DRUG

Doxorubicin

50 mg of doxorubicin per square meter administrated IV on day 1 of each chemotherapy cycle

DRUG

Vincristine

1.4 mg of vincristine per square meter, up to a maximal dose of 2 mg, administrated IV on day 1 of each chemotherapy cycle

DRUG

Cyclophosphamide

750 mg of cyclophosphamide per square meter of body-surface area administrated IV on day 1 of each chemotherapy cycle

DRUG

prednisone

100 mg of prednisone administrated PO per day for five days, day 1-5 of each chemotherapy cycle

Trial Locations (35)

2025

Institut of Oncology, Hematology Department, Chisinau

10000

CH Merkur, Zagreb

CHC Zagreb, Zagreb

11000

Clinical Hospital Center Zemun, Belgrade

Clinical Hospital Center Zvezdara, Belgrade

Military Hospital Academy, Belgrade

21029

Vinnitsya Regional Clinical Oncology Dispensary, Chemotherapy Department,, Vinnitsya

25011

"Utility Enterprise Kirovograd regional oncology dispensary", Kirovohrad

35000

"GH dr.Josip Bencevic", Slavonski Brod

36011

Poltava regional oncology hospital, heamotherapy department, Poltava

45634

Volyn' Regional clinical hospital, Haematology Department, Lutsk

49102

"Municipal Institution Dnipropetrovsk City multi-field Clinical Hospital #4, Oncology and medical radiology department", Dnipropetrovsk

50048

Kryvyi Rih Oncology Dispensary, Dnipropetrovsk Highway, Kryvyi Rih

54058

Mykolayiv Region Clinical Hospital, Heamotology department, Mykolayiv

58013

"Public utility Chernivtsi regional clinical oncology dispensary, Day patient department", Chernivtsi

61070

Kharkiv Regional Clinical Oncology Centre, Deartment of haematology, Kharkiv

69040

Regional Oncology dispensary, Zaporizhzhia

69600

Zaporizhzhya Regional Clinical Hospital, Deartment of haematology and intensive therapy, Zaporizhzhia

76008

Regional Clinical Hospital of Ivano-Frankivsk, Hematology Department., Ivano-Frankivsk

76018

Regional Clinical Oncology Dispensary, Chemotherapy Department, Ivano-Frankivsk

79044

"State institution Institute for haemotopathology and haemotransfusion of National Academy of science of Ukraine", Lviv

88000

Regional clinical Hospital named after Novak, Hematology Department, Uzhhorod

78 000

University Clinical Center Banja Luka, Banja Luka

71 000

University Clinical Center Sarajevo, Sarajevo

75 000

University Clinical Center Tuzla, Tuzla

72 000

General Hospital Zenica, Zenica

0112

HEMA, Tbilisi

0179

S. Khechinashvili state University clinic, Tbilisi

0186

Medulla - Chemotherapy and Immunotherapy Clinic, Tbilisi

59-220

Wojewódzki Szpital Specjalistyczny w Legnicy, Oddział Hematologiczny, Legnica

20-081

Samodzielny Publiczny Szpital Kliniczny nr1, Klinika Hematologii i Transplantacji Szpiku, Lublin

45-061

Szpital Wojewódzki w Opolu, Oddział Hematologii i Onkologii Hematologicznej, Opole

02-106

MTZ Clinical Research Sp. Z o.o., Warsaw

03022

National Institute of Cancer, Department of chemotherapy, Kiev

03115

Kiev City Clinical Oncological Center, Department of chemotherapy #2, Kiev

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mabion SA

INDUSTRY

NCT02617485 - MabionCD20 Compared to MabThera in Lymphoma Patients | Biotech Hunter | Biotech Hunter