Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
124
Countries
1
Sites
19
acute lymphoblastic leukemia
To compare efficacy of obinutuzumab and rituximab in adult patients with newly diagnosed CD20-positive ALL. The efficacy for this purpose is defined as the proportion of patients achieving complete remission (CR) with MRD level <0.1% of bone marrow cells after one course of induction treatment
Key facts
- Sponsor
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15], Diseases [C] - Neoplasms [C04]
- Trial duration
- 6 Oct 2021 → 21 Apr 2026
- Decision date (initial)
- 2024-10-07
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Medical Research Agency
External identifiers
- EU CT number
- 2024-517389-40-00
- EudraCT number
- 2020-005326-28
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To compare efficacy of obinutuzumab and rituximab in adult patients with newly diagnosed CD20-positive ALL. The efficacy for this purpose is defined as the proportion of patients achieving complete remission (CR) with MRD level <0.1% of bone marrow cells after one course of induction treatment
Secondary objectives 1
- To compare efficacy and safety of obinutuzumab and rituximab in adult patients with newly diagnosed CD20-positive ALL according to the defined secondary endpoints
Conditions and MedDRA coding
acute lymphoblastic leukemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10000845 | Acute lymphoblastic leukemia | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age ≥18 years.
- Newly diagnosed ALL with CD20 expression on at least 20% of blasts
- Signed written informed consent.
- Adequate contraception in case of women with child-bearing potential.
Exclusion criteria 11
- Lymphoblastic lymphoma with bone marrow blasts <20%.
- Patients with a history of chronic myeloid leukemia or other myeloproliferative disease
- Major surgery within 4 weeks before enrollment
- Impaired cardiac function: ejection fraction <40% on echocardiography, QTc interval >450 ms on baseline ECG. Myocardial infarction within 6 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias).
- Active infection e.g. HBV, HCV, HIV
- Other concurrent severe and/or uncontrolled medical conditions: patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease.
- Serum creatinine >2 times the upper normal limit (UNL) of the laboratory, total bilirubin> 2.5 UNL unless related to ALL, AST or ALT >5 UNL, unless related to ALL
- Intolerance to treatment with monoclonal antibody.
- Positive pregnancy test (β-HCG) for women of childbearing age
- Inability to obtain written informed consent
- Inability to comply with regular monitoring.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The proportion of patients achieving complete remission (CR) with MRD level <0.1% of bone marrow cells after one course of induction treatment
Secondary endpoints 8
- The proportion of patients achieving CR with MRD level <0.01% of bone marrow cells after consolidation.
- CR rate after Induction I.
- Overall CR rate in 24 month follow-up.
- Probability of overall survival (OS) in 24 month follow-up
- Probability of relapse-free survival (RFS) in 24 month follow-up
- Probability of event-free survival (EFS) in 24 month follow-up
- Cumulative incidence of relapse in 24 month follow-up
- Rate of adverse events in 24 month follow-up.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB32751 · Substance
- Active substance
- Obinutuzumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 15000 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
SUB12570MIG · Substance
- Active substance
- Rituximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 375 mg/m2 milligram(s)/sq. meter
- Max total dose
- 5625 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Sponsor organisation
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Address
- Ul. Wybrzeze Armii Krajowej 15
- City
- Gliwice
- Postcode
- 44-102
- Country
- Poland
Scientific contact point
- Organisation
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Contact name
- Clinical Research Support Center
Public contact point
- Organisation
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Contact name
- Clinical Research Support Center
Locations
1 EU/EEA country · 19 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 124 | 19 |
| Rest of world | — | 0 | — |
Investigational sites
Uniwersytecki Szpital Kliniczny W Poznaniu
Oddział Hematologii i Transplantacji Szpiku, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Oddział Hematologii Onkologicznej, Ul. Ks. Jozefa Bielawskiego 18, 36-200, Brzozow
Samodzielny Publiczny Szpital Kliniczny Im.Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego W Katowicach
Oddział Hematologii i Transplantacji Szpiku, Ul. Francuska 20/24, 40-027, Katowice
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Klinika Hematoonkologii i Transplantacji Szpiku, Ul. Stanislawa Staszica 11, 20-081, Lublin
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Centrum Onkologii i Traumatologii, Ul. Pabianicka 62, 93-513, Lodz
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Klinika Hematologii i Transplantacji Szpiku, Ul. Prezydenta Stefana Artwinskiego 3, 25-734, Kielce
Uniwersytecki Szpital Kliniczny W Bialymstoku
Klinika Hematologii, Chorób Wewnętrznych i Angiologii z Pododdziałem Transplantacji Komórek Krwiotw., Ul. Marii Curie-Sklodowskiej 24a, 15-276, Bialystok
Uniwersytecki Szpital Kliniczny Nr 1 Im. Prof. Tadeusza Sokolowskiego Pum W Szczecinie
Klinika Hematologii z Oddziałem Transplantacji Szpiku, Ul. Unii Lubelskiej 1, 71-252, Szczecin
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
Oddział Kliniczny Hematologii i Chorób Wewnętrznych z Ośrodkiem Transplantacji Szpiku, Al. Wojska Polskiego 37, 10-228, Olsztyn
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu
Oddział Hematologii, Ul. Sw. Jozefa 53/59, 87-100, Torun
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Oddział Hematologii i Chorób Wewnętrznych z Pododdziałem Dziennym, Os. Zlotej Jesieni 1, 31-826, Cracow
Instytut Hematologii I Transfuzjologii
Klinika Hematologii, Ul Indiry Gandhi 14, 02-776, Warsaw
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Transplantacji Szpiku i Onkohematologii, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Klinika Hematologii, Transplantologii i Chorób Wewnętrznych, Ul. Ulica Stefana Banacha 1a, 02-097, Warsaw
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Oddział Hematologiczny, Transplantologiczny oraz Immunologii Klinicznej, Ul. Grabiszynska 105, 53-439, Wroclaw
Wojewodzki Szpital Specjalistyczny W Legnicy
Oddział Hematologiczny, Ul. Jaroslawa Iwaszkiewicza 5, 59-220, Legnica
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Klinika Chorób Wewnętrznych i Hematologii, Ulica Szaserow 128, 04-141, Warsaw
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Oddział Hematologii i Transplantacji Szpiku, Ul. Dra Kazimierza Jaczewskiego 7, 20-090, Lublin
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Poland | 2021-10-06 | 2021-12-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_blinded | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_blinded | 4.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Blitzima | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Gazyvaro | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Mabthera | 2.0 |
| Synopsis of the protocol (for publication) | D1_Synopsis_PALG ALL7 OVERALL_blinded | 3.0 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-28 | Poland | Acceptable 2024-09-30
|
2024-10-07 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-30 | Poland | Acceptable 2024-09-30
|
2024-12-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-07 | Poland | Acceptable | 2025-03-18 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-11 | Poland | Acceptable | 2025-09-11 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-18 | Poland | Acceptable 2025-10-31
|
2025-11-04 |