CD20-positive Acute Lymphoblastic LeukemiaPhase 2OVERALLNCT04920968
Obinutuzumab Versus Rituximab for Acute Lymphoblastic Leukemia/PALG ALL7 "OVERALL"
A Phase 2 study testing Obinutuzumab and Rituximab in people with CD20-positive Acute Lymphoblastic Leukemia, run by Maria Sklodowska-Curie National Research Institute of Oncology at 19 sites in Poland.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CD20-positive Acute Lymphoblastic Leukemia
- What is being tested?
- Obinutuzumab and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 19 sitesPoland
- Study dates
- 5 Oct 2021to 21 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Newly diagnosed Acute lymphoblastic leukemia with CD20 expression on at least 20% of blasts.
- Signed written informed consent.
- Adequate contraception in case of women with child-bearing potential
Who cannot join
- 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 electrocardiogram. 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. hepatitis B virus, hepatitis C virus, human immunodeficiency virus
- 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.
Show all 11Show fewer
- Serum creatinine > 2 times the upper normal limit of the laboratory, total bilirubin> 2.5 upper normal limit unless related to Acute lymphoblastic leukemia, aspartate aminotransferase or alanine aminotransferase > 5 upper normal limit, unless related to Acute lymphoblastic leukemia
- Intolerance to treatment with monoclonal antibody.
- Positive pregnancy test (beta human chorionic gonadotropin) for women of childbearing age.
- Inability to obtain written informed consent.
- Inability to comply with regular monitoring.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Poland19 sites
Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego
Bialystok
Oddział Hematologii Onkologicznej Podkarpacki Ośrodek Onkologiczny
Brzozów
Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach
Gliwice
Klinika Hematologii i Transplantacji Szpiku, Samodzielny Publiczny Szpital Kliniczny
Katowice
Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii
Kielce
Oddział Hematologii i Chorób Wewnętrznych z Pododdziałem Dziennym Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.
Krakow
Oddział Hematologiczny Wojewódzkiego Szpitala Specjalistycznego w Legnicy
Legnica
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
Lodz
Klinika Hematoonkologii I Transplantacji Szpiku, Uniwersytet Medyczny w Lublinie
Lublin
Oddział Hematologii i Transplantacji Szpiku Centrum Onkologii Ziemi Lubelskiej im. Św. Jana z Dukli w Lublinie
Lublin
Oddział Kliniczny Hematologii Samodzielnego Publicznego Zakładu Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn
Klinika Hematologii i Chorób Rozrostowych Układu Krwiotwórczego Uniwersytetu Medycznego w Poznaniu
Poznan
Klinika Hematologii Pomorskiego Uniwersytetu Medycznego
Szczecin
Oddział Hematologii, Specjalistyczny Szpital Miejski
Torun
Klinika Chorób Wewnętrznych i Hematologii Wojskowy Instytut Medyczny
Warsaw
Klinika Hematologii, Instytut Hematologii i Transfuzjologii
Warsaw
Klinika Hematologii, Onkologii i Chorób Wewnętrznych Warszawskiego Uniwersytetu Medycznego
Warsaw
Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
Wroclaw
Oddział Hematologiczny Z Oddziałem Nowotworów Krwi Dolnośląskie Centrum Transplantacji Komórkowych Z Krajowym Bankiem Dawców Szpiku
Wroclaw
About this study
Official title: Efficacy and Safety of Obinutuzumab Versus Rituximab in Combination With Chemotherapy for Adult Patients With Newly Diagnosed CD20-positive Acute Lymphoblastic Leukemia
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).
- Being tested
- Obinutuzumab, Rituximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObinutuzumabDrug
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).
RituximabDrug
Also called Activ comparator
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.)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Obinutuzumab |
| 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. Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving complete remission with Minimal Residual Disease level <0.1% of bone marrow cells after one course of induction treatment.
Measured: assessed between days 33-34 since start of Induction I
Secondary outcomes (8)
The proportion of patients achieving complete remission with Minimal Residual Disease level <0.01% of bone marrow cells after consolidation.
Measured: assessed between days 20-28 since start of last course of consolidation
complete remission rate after Induction I
Measured: assessed between days 33-34 since start of Induction I
Overall complete remission
Measured: in 24month follow up
Probability of overall survival
Measured: in 24 month follow up
Probability of relapse-free survival
Measured: in 24 month follow up
Probability of event-free survival
Measured: in 24 month follow up
Cumulative incidence of relapse
Measured: in 24 month follow up
Rate of adverse events
Measured: in 24 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start5 Oct 2021
- Primary completion21 Apr 2026
- Study completion21 Apr 2026
Why it stopped: Following the recommendation of the Data Monitoring Committee (DMC), based on the results of the interim analysis, the Sponsor has decided to terminate the study prematurely
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD20-positive Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- KCRI
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920968
- Sponsor's protocol ID
- 20-NIO-0002
- Acronym
- OVERALL
- Status last verified
- Aug 2026
- First submitted
- 25 Apr 2021
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Obinutuzumab Versus Rituximab in Combination With Chemotherapy for Adult Patients With Newly Diagnosed CD20-positive Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT04920968
- Acronym / sponsor ID
- OVERALL / 20-NIO-0002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following the recommendation of the Data Monitoring Committee (DMC), based on the results of the interim analysis, the Sponsor has decided to terminate the study prematurely
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Collaborators
- KCRI
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 21 Apr 2026 (actual)
- Study completion
- 21 Apr 2026 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obinutuzumab | Experimental | Drug: ObinutuzumabPatients 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. |
| Rituximab | Active comparator | Drug: RituximabPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years.
- Newly diagnosed Acute lymphoblastic leukemia with CD20 expression on at least 20% of blasts.
- Signed written informed consent.
- Adequate contraception in case of women with child-bearing potential
Key exclusion criteria (11 listed)
- 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 electrocardiogram. 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. hepatitis B virus, hepatitis C virus, human immunodeficiency virus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObinutuzumabChemotherapy 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). | Drug | Obinutuzumab |
| RituximabAlso: Activ comparatorChemotherapy 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.) | Drug | Rituximab |
Primary outcome
Proportion of patients achieving complete remission with Minimal Residual Disease level <0.1% of bone marrow cells after one course of induction treatment.
Time frame: assessed between days 33-34 since start of Induction I
8 secondary outcomes
The proportion of patients achieving complete remission with Minimal Residual Disease level <0.01% of bone marrow cells after consolidation.
Time frame: assessed between days 20-28 since start of last course of consolidation
complete remission rate after Induction I
Time frame: assessed between days 33-34 since start of Induction I
Overall complete remission
Time frame: in 24month follow up
Probability of overall survival
Time frame: in 24 month follow up
Probability of relapse-free survival
Time frame: in 24 month follow up
Probability of event-free survival
Time frame: in 24 month follow up
Cumulative incidence of relapse
Time frame: in 24 month follow up
Rate of adverse events
Time frame: in 24 month follow up
Results and safety
The study was stopped early (reason given: Following the recommendation of the Data Monitoring Committee (DMC), based on the results of the interim analysis, the Sponsor has decided to terminate the study prematurely). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Obinutuzumab and Rituximab in people with CD20-positive Acute Lymphoblastic Leukemia, run by Maria Sklodowska-Curie National Research Institute of Oncology at 19 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Following the recommendation of the Data Monitoring Committee (DMC), based on the results of the interim analysis, the Sponsor has decided to terminate the study prematurely). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving complete remission with Minimal Residual Disease level <0.1% of bone marrow cells after one course of induction treatment. (time frame: assessed between days 33-34 since start of Induction I). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.