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IntReALL BCP 2020 – International Study for Treatment of Childhood Relapsed Precursor B-cell ALL 2020
EU CTIS ID: 2023-509392-17-00
What this study is testing
SR Arm induction:Improvement of EFS probability with InO versus ALLR3-Mitox SR-MRD good response consolidation: Improvement of 4 years DFS with 3 courses of blinatumomab HR Arm with CR2 consolidation: DFS non-inferiority with one consolidation chemotherapy course HC1 before blinatumomab compared to historical controls with 2 consolidation courses HC1 and 2 Isolated extramedullary relapses: EFS improvement with blinatumomab in late consolidation compared to historical controls
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- All study questions: Confirmed diagnosis of 1st relapsed B-cell precursor ALL
- All study questions: Start of treatment falling into the study period
- Meeting SR criteria: No previous history of veno-occlusive disease (VOD)/ sinusoidal obstruction syndrome (SOS)
- All study questions: No participation in other clinical trials 30 day prior to study enrolment that interfere with this protocol, except trials for primary ALL
- Specific for SR induction randomization: Meeting SR criteria
- Meeting SR criteria: BM involvement (≥ 1% leukemic blasts)
You likely can't join 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
- Severe concomitant disease that, according to the treating physician, does not allow treatment according to the protocol at the investigator’s discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)
- Subjects unwilling or unable to comply with the study procedures
- Subjects who are legally detained in an official institute
- 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
See the full eligibility criteria
Who can join
- All study questions: Confirmed diagnosis of 1st relapsed B-cell precursor ALL
- All study questions: Start of treatment falling into the study period
- Meeting SR criteria: No previous history of veno-occlusive disease (VOD)/ sinusoidal obstruction syndrome (SOS)
- All study questions: No participation in other clinical trials 30 day prior to study enrolment that interfere with this protocol, except trials for primary ALL
- Specific for SR induction randomization: Meeting SR criteria
- Meeting SR criteria: BM involvement (≥ 1% leukemic blasts)
- Meeting SR criteria: CD22 positive ALL (>80% confirmed by flow-cytometry)
- Specific for SR MRD poor response consolidation: Meeting SR criteria with bone marrow involvement at relapse diagnosis
- Specific for SR MRD poor response consolidation: M1/CR2 and MRD ≥ 10-4 after induction
- Specific for SR MRD poor response consolidation: CD19 positive ALL at relapse (>10%)
- Specific for SR MRD good response consolidation: Meeting SR criteria with bone marrow involvement at relapse diagnosis
- Specific for HR consolidation arm: M1/CR2 after induction therapy
- Specific for SR MRD good response consolidation: M1/CR2 and MRD < 10-4 after induction
- Specific for SR MRD good response consolidation: 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
- All study questions: 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
- Specific for HR consolidation arm: CD19 positive ALL at relapse (>10%)
- Specific for IEM arm: Histology or cytology proven extramedullary relapse
- Specific for IEM arm: No bone marrow involvement (M1 at relapse diagnosis) and bone marrow MRD <1%
- Specific for IEM arm: CD19 positive ALL at relapse (>10%)
- All study questions: Patient enrolled in a participating center
- All study questions: Written informed consent (IC)
What rules you out
- 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
- Severe concomitant disease that, according to the treating physician, does not allow treatment according to the protocol at the investigator’s discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)
- Subjects unwilling or unable to comply with the study procedures
- Subjects who are legally detained in an official institute
- 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 Bbreast feeding until 12 months after end of anti-leukemic therapy
- Relapse post allogeneic HSCT
- 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
- Specific for SR induction randomization: Patients with intolerance to PEG-asparagniase and also to Erwinase are stratified to the inotuzumab arm
- Relapse post chimeric antigen receptor T-cell (CAR-T) therapy
- Specific for SR induction randomization: Patients with insufficient expression of CD22 (< 80%) on leukemic blasts, they are assigned to the control chemotherapy arm
- Specific for blinatumomab treatment: Clinically relevant CNS pathology requiring treatment (eg, unstable epilepsy)
- Specific for blinatumomab treatment: Evidence of current CNS (CNS 2, CNS 3) involvement by ALL. Subjects with CNS relapse at the time of relapse are eligible if CNS is successfully treated prior to enrollment
- 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)
- Specific for SR induction randomization: Prior confirmed severe (grade 3 or 4) or ongoing VOD/SOS
- Specific for SR induction randomization: Serious ongoing hepatic disease (e.g., cirrhosis, active hepatitis) not related to the current ALL relapse or current diagnostic/therapeutic measures
- Specific for SR induction randomization: ALT > 2,5 x ULN (at relapse diagnosis before start of cytoreduction) and/or bilirubin > 1.5 x ULN
- No consent is given for saving and propagation of pseudonymized medical data for study reasons
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Australia
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Australia; Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.