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| Name | Class |
|---|---|
| KCRI | OTHER |
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A multicenter, prospective, randomized and controlled study to compare the efficacy and safety of obinutuzumab and rituximab in adult ALL patients with CD20 expression.Study population is 124 patients (62 in each study group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obinutuzumab | Experimental | Patients in reference arm (Arm A) will receive rituximab. Patients in experimental arm (Arm B) will receive obinutuzumab instead of rituximab in the same time-points. |
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| Rituximab | Active Comparator | Patients in reference arm (Arm A) will receive rituximab. Patients in experimental arm (Arm B) will receive obinutuzumab instead of rituximab in the same time-points. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obinutuzumab | Drug | Chemotherapy will be conducted according to PALG ALL7 protocol, which is considered a standard of care in Poland. Patients in experimental arm will receive obinutuzumab .Obinutuzumab: 1000 mg i.v. (first infusion divided into 100 mg on d. 1 and 900 mg on d. 2). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving complete remission with Minimal Residual Disease level <0.1% of bone marrow cells after one course of induction treatment. | assessed between days 33-34 since start of Induction I |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients achieving complete remission with Minimal Residual Disease level <0.01% of bone marrow cells after consolidation. | assessed between days 20-28 since start of last course of consolidation | |
| complete remission rate after Induction I |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sebastian Giebel, prof. dr n.med. | Contact | 32 278 85 23 | Sebastian.Giebel@io.gliwice.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego | Recruiting | Bialystok | Poland |
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| Rituximab | Drug | Chemotherapy will be conducted according to PALG ALL7 protocol, which is considered a standard of care in Poland.The protocol includes the use of rituximab in combination chemotherapy. Rituximab: 375 mg/m2 intravenously (i.v.) |
|
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| assessed between days 33-34 since start of Induction I |
| Overall complete remission | in 24month follow up |
| Probability of overall survival | in 24 month follow up |
| Probability of relapse-free survival | in 24 month follow up |
| Probability of event-free survival | in 24 month follow up |
| Cumulative incidence of relapse | in 24 month follow up |
| Rate of adverse events | in 24 month follow up |
| Oddział Hematologii Onkologicznej Podkarpacki Ośrodek Onkologiczny | Recruiting | Brzozów | Poland |
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| Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach | Recruiting | Gliwice | Poland |
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| Klinika Hematologii i Transplantacji Szpiku, Samodzielny Publiczny Szpital Kliniczny | Recruiting | Katowice | Poland |
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| Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii | Recruiting | Kielce | Poland |
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| Oddział Hematologii i Chorób Wewnętrznych z Pododdziałem Dziennym Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o. | Recruiting | Krakow | Poland |
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| Oddział Hematologiczny Wojewódzkiego Szpitala Specjalistycznego w Legnicy | Recruiting | Legnica | Poland |
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| Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi | Recruiting | Lodz | Poland |
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| Klinika Hematoonkologii I Transplantacji Szpiku, Uniwersytet Medyczny w Lublinie | Recruiting | Lublin | Poland |
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| Oddział Hematologii i Transplantacji Szpiku Centrum Onkologii Ziemi Lubelskiej im. Św. Jana z Dukli w Lublinie | Recruiting | Lublin | Poland |
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| Oddział Kliniczny Hematologii Samodzielnego Publicznego Zakładu Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie | Recruiting | Olsztyn | Poland |
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| Klinika Hematologii i Chorób Rozrostowych Układu Krwiotwórczego Uniwersytetu Medycznego w Poznaniu | Recruiting | Poznan | Poland |
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| Klinika Hematologii Pomorskiego Uniwersytetu Medycznego | Recruiting | Szczecin | Poland |
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| Oddział Hematologii, Specjalistyczny Szpital Miejski | Recruiting | Torun | Poland |
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| Klinika Chorób Wewnętrznych i Hematologii Wojskowy Instytut Medyczny | Recruiting | Warsaw | Poland |
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| Klinika Hematologii, Instytut Hematologii i Transfuzjologii | Recruiting | Warsaw | Poland |
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| Klinika Hematologii, Onkologii i Chorób Wewnętrznych Warszawskiego Uniwersytetu Medycznego | Recruiting | Warsaw | Poland |
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| Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku | Recruiting | Wroclaw | Poland |
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| Oddział Hematologiczny Z Oddziałem Nowotworów Krwi Dolnośląskie Centrum Transplantacji Komórkowych Z Krajowym Bankiem Dawców Szpiku | Recruiting | Wroclaw | Poland |
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| ID | Term |
|---|---|
| C543332 | obinutuzumab |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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