Childhood Acute Lymphoblastic LeukemiaNCT04723342
Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2019 Pilot
A study testing Blinatumomab in people with Childhood Acute Lymphoblastic Leukemia, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 4 sites in Russia.
Trial summary
THE PURPOSE OF THE STUDY is to optimize the therapy of patients with primary B-cell precursor acute lymphoblastic leukemia (BCP-ALL) by including monoclonal bispecific antibodies in post-induction treatment with simultaneous reduction of chemotherapy. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Childhood Acute Lymphoblastic Leukemia
- What is being tested?
- Blinatumomab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 4 sitesRussia
- Study dates
- 1 Feb 2020to Dec 2025
- Phase
- Interventional
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- This study included patients with B-cell precursor ALL (BCP-ALL) diagnosed or confirmed in one of the clinics participating in the study. Also following criteria should be considered at the diagnosis for each case:
- Age at diagnosis at 1 to 18 years.
- The start of induction therapy within a time interval of study recruitment phase.
- The diagnosis of BCP-ALL is to be proved by the morphological, cytochemical, and immunological analysis of tumor cells in bone marrow in the reference laboratories of Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology (D. Rogachev NMRCPHOI).
- CD19 expression on tumor cells.
- Informed consent of the patient parents (guardians)
Who cannot join
- Any non-compliance with the inclusion criteria.
- ALL is a second malignancy.
- There is severe concomitant disease, which significantly impedes chemotherapy protocol (such as multiple malformations, heart diseases, metabolic disorders, etc.);
- The patient was treated before for a long time with cytotoxic drugs.
- Initial CNS (central nervous system) involvement (status CNSII or CNSIII).
- Initial leukocyte count ≥100×109/L (except for patients with significant translocations).
- Patients not achieved cytological remission after induction
Trial locations and contacts
4 sites in 1 country.
Russia4 sites, 4 recruiting
- Recruiting
Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology
Moscow
- Recruiting
National Medical Research Center of Oncology named after N.N. Blokhin
Moscow
- Recruiting
Russian Children's Clinic Hospital; Pirogov Russian National Research Medical University
Moscow
- Recruiting
Almazov National Medical Research Centre
Saint Petersburg
About this study
Official title: Treatment of Children and Adolescents With Primary B-precursor Acute Lymphoblastic Leukemia With Combination Chemotherapy and Immunotherapy
THE PURPOSE OF THE STUDY is to optimize the therapy of patients with primary B-cell precursor acute lymphoblastic leukemia (BCP-ALL) by including monoclonal bispecific antibodies in post-induction treatment with simultaneous reduction of chemotherapy.
QUESTIONS AND OBJECTIVES OF THE STUDY:
- to determine the efficacy and feasibility of chemotherapy and immunotherapy combination in comparison with standard PCT in children and adolescents with newly diagnosed BCP-ALL;
- to determine the safety and toxicity of chemotherapy and immunotherapy combination in comparison with standard PCT in children and adolescents with newly diagnosed BCP-ALL;
- to determine the possibility of chemotherapy reducing when immunotherapy is included in the treatment regimen without loss of effectiveness;
- to determine the possibility of reducing the maintenance therapy duration to 1 year when immunotherapy is included in the treatment regimen without loss of effectiveness.
- Conditions
- Childhood Acute Lymphoblastic Leukemia
- Being tested
- Blinatumomab
- Keywords
- Acute lymphoblastic leukemia, Children, Chemotherapy, Immunotherapy, Blinatumomab
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinatumomabDrug
Blinatumomab, intravenously, as continuous 24 hours infusion 1-7 days - 5 μg/m2/day, 8-28 day - 15 μg/m2/day
1 course after induction treatment
| Study group | Role | What they receive |
|---|---|---|
| Blinatumomab | Experimental | Consolidation therapy with Blinatumomab administration Receives: Drug: Blinatumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal residual disease level
Measured: On the last day of the blinatumomab course, on average at 11 weeks of protocol
Minimal residual disease level
Measured: 6 months after starting maintenance therapy
Minimal residual disease level
Measured: 1 year after starting maintenance therapy
Event-free survival
Measured: 3 years after study start
Event-free survival
Measured: 5 years after study start
Secondary outcomes (6)
Overall survival
Measured: 3 years after study start
Overall survival
Measured: 5 years after study start
Cumulative incidence of relapse
Measured: 3 years after study start
Cumulative incidence of relapse
Measured: 5 years after study start
Remission death rate
Measured: 3 years after study start
Remission death rate
Measured: 5 years after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start1 Feb 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander I. Karachunskiy, Professor,MD, Principal investigator, Federal Research Institute of Pediatric Hematology, Oncology and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723342
- Sponsor's protocol ID
- ALL-MB 2019 Pilot
- Status last verified
- Jan 2021
- First submitted
- 19 Jan 2021
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.
PubMed 41671463
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Children and Adolescents With Primary B-precursor Acute Lymphoblastic Leukemia With Combination Chemotherapy and Immunotherapy
- ClinicalTrials.gov ID
- NCT04723342
- Acronym / sponsor ID
- ALL-MB 2019 Pilot
- Conditions
- Childhood Acute Lymphoblastic Leukemia
- Keywords
- Acute lymphoblastic leukemia, Children, Chemotherapy, Immunotherapy, Blinatumomab
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and ImmunologyUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Jan 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.
THE PURPOSE OF THE STUDY is to optimize the therapy of patients with primary B-cell precursor acute lymphoblastic leukemia (BCP-ALL) by including monoclonal bispecific antibodies in post-induction treatment with simultaneous reduction of chemotherapy.
QUESTIONS AND OBJECTIVES OF THE STUDY:
- to determine the efficacy and feasibility of chemotherapy and immunotherapy combination in comparison with standard PCT in children and adolescents with newly diagnosed BCP-ALL;
- to determine the safety and toxicity of chemotherapy and immunotherapy combination in comparison with standard PCT in children and adolescents with newly diagnosed BCP-ALL;
- to determine the possibility of chemotherapy reducing when immunotherapy is included in the treatment regimen without loss of effectiveness;
- to determine the possibility of reducing the maintenance therapy duration to 1 year when immunotherapy is included in the treatment regimen without loss of effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blinatumomab | Experimental | Drug: BlinatumomabConsolidation therapy with Blinatumomab administration |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- This study included patients with B-cell precursor ALL (BCP-ALL) diagnosed or confirmed in one of the clinics participating in the study. Also following criteria should be considered at the diagnosis for each case:
- Age at diagnosis at 1 to 18 years.
- The start of induction therapy within a time interval of study recruitment phase.
- The diagnosis of BCP-ALL is to be proved by the morphological, cytochemical, and immunological analysis of tumor cells in bone marrow in the reference laboratories of Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology (D. Rogachev NMRCPHOI).
- CD19 expression on tumor cells.
Key exclusion criteria (7 listed)
- Any non-compliance with the inclusion criteria.
- ALL is a second malignancy.
- There is severe concomitant disease, which significantly impedes chemotherapy protocol (such as multiple malformations, heart diseases, metabolic disorders, etc.);
- The patient was treated before for a long time with cytotoxic drugs.
- Initial CNS (central nervous system) involvement (status CNSII or CNSIII).
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 |
|---|---|---|
| BlinatumomabBlinatumomab, intravenously, as continuous 24 hours infusion 1-7 days - 5 μg/m2/day, 8-28 day - 15 μg/m2/day 1 course after induction treatment | Drug | Blinatumomab |
Primary outcome
Minimal residual disease level
Time frame: On the last day of the blinatumomab course, on average at 11 weeks of protocol
Minimal residual disease level
Time frame: 6 months after starting maintenance therapy
Minimal residual disease level
Time frame: 1 year after starting maintenance therapy
Event-free survival
Time frame: 3 years after study start
Event-free survival
Time frame: 5 years after study start
6 secondary outcomes
Overall survival
Time frame: 3 years after study start
Overall survival
Time frame: 5 years after study start
Cumulative incidence of relapse
Time frame: 3 years after study start
Cumulative incidence of relapse
Time frame: 5 years after study start
Remission death rate
Time frame: 3 years after study start
Remission death rate
Time frame: 5 years after study start
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Derived from this study: PubMed 41671463Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.
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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.
Alexander I. Karachunskiy, Professor,MD principal investigator
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blinatumomab in people with Childhood Acute Lymphoblastic Leukemia, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 4 sites in Russia.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Russia. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander I. Karachunskiy, Professor,MD (+7-926-218-84-09, info@mbstudy.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal residual disease level (time frame: On the last day of the blinatumomab course, on average at 11 weeks of protocol). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04723342, which also lists 1 linked publication.
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 25 Jan 2021.