International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 (IntReALL BCP 2020)

Starting soon · Phase 3

Conditions studied: B-Cell Acute Lymphoblastic Leukaemia

In brief

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.

Key facts

Study ID

NCT07476729

Run by

Charite University, Berlin, Germany

People needed

750

Starts

2026-04-01

Expected to finish

2033-03-31

Last updated by the study team

2026-03-17

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Known hypersensitivity to the active substances or excipients of the IMP's or the SOC drugs, except to PEG-asparaginase which can be replaced by Erwinase
• Left ventricular ejection fraction (LVEF) < 50% or fractional shortening < 25%, and/or current or prior treatment for cardiomyopathy and/or history of clinically significant arrhythmias
• Pregnancy or positive pregnancy test in female patients (urine sample positive for β-HCG > 10 U/l) at screening or within 7 days prior to the initiation of study treatment
• Sexually active adolescents and adults not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of anti-leukemic therapy
• Women not willing to refrain from breast feeding until 12 months after end of anti-leukemic therapy
• Relapse post allogeneic HSCT
• Relapse post chimeric antigen receptor T-cell (CAR-T) therapy
• The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian
• Objection to the study participation by a minor patient
• Patients in a dependent or subordinate relationship to the investigator or site staff (e.g. employees, relatives, or students)
• No consent is given for saving and propagation of pseudonymized medical data for study reasons
• Patients with any concurrent medical condition, laboratory abnormality, concomitant treatment, or comorbidity that, in the investigator's clinical judgment would
• compromise the patient's ability to safely receive or tolerate inotuzumab ozogamicin and/or blinatumomab
• significantly interfere with assessment of treatment efficacy or safety
• make it unlikely that the patient would derive clinical benefit from protocol therapy
• preclude adherence to study procedures or follow-up requirements
• Subjects unwilling or unable to comply with the study procedures
• Subjects who are legally detained in an official institute
• Specific for SR induction randomization:
• Prior confirmed severe (grade 3 or 4) or ongoing VOD/SOS
• Serious ongoing hepatic disease (e.g., cirrhosis, active hepatitis) not related to the current ALL relapse or current diagnostic/therapeutic measures
• ALT > 2,5 x ULN (at relapse diagnosis before start of cytoreduction) and/or bilirubin > 1.5 x ULN
• Patients with intolerance to PEG-asparagniase and also to Erwinase are stratified to the inotuzumab arm
• Patients with insufficient expression of CD22 (< 80%) on leukemic blasts, they are assigned to the control chemotherapy arrm
• Specific for blinatumomab treatment:

Where it is running

• St. Anna Kinderspital GmbH — Vienna, Austria
• Ghent University Hospital — Ghent, Belgium
• Fakultni Nemocnice V Motole — Prague, Czechia
• Rigshospitalet — Copenhagen, Denmark
• HUS Helsinki University Hospital — Helsinki, Finland
• CHU de NICE, Hôpital L'ARCHET — Nice, France
• Charité - Universitätsmedizin Berlin — Berlin, Germany
• Semmelweis University — Budapest, Hungary
• Tel Aviv Sourasky Medical Centre Dana-Dwek Children's Hospital — Tel Aviv, Israel
• Ospedale Pediatrico Bambino Gesu — Rome, Italy
• Prinses Máxima Centrum — Utrecht, Netherlands
• University Wroclaw — Wroclaw, Poland
• Instituto Português de Oncologia de Lisboa — Lisbon, Portugal
• Fundeni Clinical Institute, Pediatric Clinic Fundeni — Bucharest, Romania
• Univerzity Komenského a Národného — Bratislava, Slovakia
• University Medical Centre Ljubljana — Ljubljana, Slovenia
• University Clinical Hospital Virgen De La Arrixaca — Murcia, Spain
• Karolinska University Hospital — Solna, Sweden
• University Children's Hospital — Zurich, Switzerland
• Acıbadem University — Istanbul, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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