B-Cell Acute Lymphoblastic Leukaemia study: Inotuzumab ozogamicin vs Blinatumomab
Official title International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 (IntReALL BCP 2020)
ClinicalTrials.gov ID: NCT07476729
What this study is testing
What is Inotuzumab ozogamicin (INO)?
Inotuzumab ozogamicin (INO) is an investigational medicine, being studied as a potential treatment for b-cell acute lymphoblastic leukaemia.
Also referred to as InO vs. R3 randomisation in SR.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 and older
You may be able to join if
- 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
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...
- Left ventricular ejection fraction (LVEF) \< 50% or fractional shortening \< 25%, and/or current or prior treatment for cardiomyopathy and/or history...
- 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...
- Sexually active adolescents and adults not willing to use highly effective contraceptive method (pearl index \<1) until 12 months after end of...
- Women not willing to refrain from breast feeding until 12 months after end of anti-leukemic therapy
- Relapse post allogeneic HSCT
See the full eligibility criteria
- 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
- Meeting SR criteria
- BM involvement (≥ 5% or ≥ 1% leukemic blasts confirmed by 2 quantitative methods)
- CD22 positive ALL (\>80% confirmed by flow-cytometry)
- Meeting SR criteria with bone marrow involvement at relapse diagnosis
- M1/CR2 and MRD ≥ 10-4 after induction
- 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
- Histology or cytology proven extramedullary relapse
- No bone marrow involvement (M1 at relapse diagnosis) and bone marrow MRD \<1%
- CD19 positive ALL at relapse (\>10%)
- 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 how well it works or safety
- make it unlikely that the patient would derive clinical benefit from protocol therapy
- preclude adherence to study procedures or follow-up requirements
- people unwilling or unable to comply with the study procedures
- 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
- Clinically relevant CNS pathology requiring treatment (eg, unstable epilepsy)
- Evidence of current CNS (CNS 2, CNS 3) involvement by ALL. people with CNS relapse at the time of relapse are eligible if CNS is successfully treated prior to enrollment Allowed systemic diseases and concomitant...
- Patients with Down Syndrome (DS) can be included as separate and descriptive population, not joining the study questions. Those with BM involvement receive inotuzumab ozogamicin for induction without randomization.
- Patients with BCR::ABL positive (Ph+) or BCR::ABL like (Ph-like) BCP ALL with TKI treatment option can be included as separate and descriptive population, not joining the study questions.
- Patients with systemic diseases such as cystic fibrosis or diabetes may be eligible for enrolment in this study only if they presumably will tolerate the protocol treatment and primary dose reductions would not be...
- Any kind of concomitant medication given due to medical reasons is allowed. Incompatibilities and drug interactions with the study medications are listed in the appendix.
- Antileukemic therapy other than scheduled in the protocol (except cytoreductive pre-phase with dexamethasone)
- Investigational drugs other than scheduled in the protocol
- Attenuated live vaccines which are strictly prohibited during and until 6 months after end of chemotherapy or 18 months after allo-HSCT
The study team makes the final eligibility decision.
Where it is enrolling
- Vienna, Austria
- Prague, Czechia
- Copenhagen, Denmark
- Nice, France
- Berlin, Germany
- Utrecht, Netherlands
- Oslo, Norway
- Murcia, Spain
- Solna, Sweden
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, but 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, 1 year and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Vienna, Austria; Prague, Czechia; Copenhagen, Denmark; Nice, France; Berlin, Germany; Utrecht, Netherlands and 3 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.