The IntReALL BCP 2020 study aims to review recent developments and findings regarding chemoimmunotherapy with inotuzumab and immunotherapy with blinatumomab and to increase the use of promising new immunotherapeutic drugs as replacements for toxic SOC chemotherapy elements.
The IntReALL BCP 2020 study has the potential to improve CR and EFS rates for all SR and HR groups, as well as for patients with IEM recurrence, by replacing toxic chemotherapy with targeted, less toxic immunotherapy strategies, and could establish these new approaches as SOC for children with relapsed BCP ALL in the future.
Who can participate
Age range
1 Year
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
For all study questions:
* Confirmed diagnosis of 1st relapsed B-cell precursor ALL
* Patients ≥ 1 year and less than 18 years of age at diagnosis of primary ALL and less than 21 years of age at date of inclusion into the study
* Patient enrolled in a participating center
* Written informed consent (IC)
* Start of treatment falling into the study period
* No participation in other clinical trials 30 days prior to study enrolment that interfere with this protocol, except trials for primary ALL
Specific for SR induction randomization:
* Meeting SR criteria
* BM involvement (≥ 5% or ≥ 1% leukemic blasts confirmed by 2 quantitative methods)
* CD22 positive ALL (\>80% confirmed by flow-cytometry)
* No previous history of veno-occlusive disease (VOD)/ sinusoidal obstruction syndrome (SOS)
Specific for SR MRD poor response consolidation:
* Meeting SR criteria with bone marrow involvement at relapse diagnosis
* M1/CR2 and MRD ≥ 10-4 after induction
* CD19 positive ALL at relapse (\>10%)
Specific for SR MRD good response consolidation:
* Meeting SR criteria with bone marrow involvement at relapse diagnosis
* M1/CR2 and MRD \< 10-4 after induction
* CD19 positive ALL at relapse (\>10%) Specific for HR consolidation arm
* Meeting HR or VHR (in case of no possibility to be treated with CAR T cells) criteria
* M1/CR2 after induction therapy
* CD19 positive ALL at relapse (\>10%)
Specific for IEM arm:
* Histology or cytology proven extramedullary relapse
* No …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
SR induction EFS
Timeframe: From enrollment until 2 years after end of treatment
2
SR-MRD good response consolidation DFS
Timeframe: From enrollment until 2 years after end of treatment
3
HR with CR2 consolidation DSF
Timeframe: From enrollment until 2 years after end of treatment
4
Isolated extramedullary manifestations: EFS
Timeframe: From enrollment until 2 years after end of treatment