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New treatment option for ACUTE LYMPHOBLASTIC LEUKEMIA
Official title A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL
ClinicalTrials.gov ID: NCT05748171
What this study is testing
What is Inotuzumab ozogamicin?
Inotuzumab ozogamicin is an investigational medicine, being studied as a potential treatment for acute lymphoblastic leukemia.
Also referred to as Besponsa.
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
- This prospective, randomized, multicenter, open-label Phase 2 study is designed to evaluate the superiority of InO monotherapy vs ALLR3 after 1 cycle of induction treatment in paediatric participants (between 1 and \<18 years) with High Risk (HR) or very high risk (VHR) first bone marrow relapse CD22-positive BCP ALL, and to evaluate the safety and tolerability, PK and long-term efficacy. Treatment with study intervention will end after induction therapy; follow-up will continue for up to 5 years from randomization.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
- 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 to 17
You may be able to join if
- Male or female participants between 1 and \<18 years of age.
- Morphologically confirmed diagnosis of first relapse HR or VHR BCP ALL; HR first relapse is defined as relapse occurring within 18 to 30 months of...
- CD22-positive ALL as defined by local institution;
- Bone marrow involvement of ≥ 5% leukemic blasts (≥ M2 status).
- Adequate serum chemistry parameters:
You likely can't join if
- Any history of prior or ongoing hepatic SOS or prior liver failure [defined as severe acute liver injury with encephalopathy and impaired synthetic...
- Prior allo-HSCT or CAR T-cell therapy.
- Isolated extramedullary leukemia.
- Philadelphia-chromosome positive ALL, ie. BCR-ABL/t(9;22) present.
- Prior therapy with a calicheamicin-conjugated antibody (eg, InO or gemtuzumab ozogamicin).
- Participants with active, uncontrolled bacterial, fungal, or viral infection.
See the full eligibility criteria
- Male or female participants between 1 and \<18 years of age.
- Morphologically confirmed diagnosis of first relapse HR or VHR BCP ALL; HR first relapse is defined as relapse occurring within 18 to 30 months of original diagnosis of ALL or within 6 months of completion of primary...
- CD22-positive ALL as defined by local institution;
- Bone marrow involvement of ≥ 5% leukemic blasts (≥ M2 status).
- Adequate serum chemistry parameters:
- An eGFR in participants 1 to \<2 years of age, or eCrCl in those 2 to \<18 years of age, ≥30 mL/min using the recommended formula in Section 10.10.2.
- AST and ALT ≤5 × institutional ULN at the time of randomization or pre-cytoreduction/general anesthesia; (Refer to Appendix 9 for France-specific requirement on the ALT/AST threshold);
- Total bilirubin ≤1.5 × institutional ULN unless the participant has documented Gilbert's syndrome;
- Prior history of thrombosis during corticosteroid use and/or asparaginase are eligible provided the patient receives anti-coagulant prophylaxis per institutional guidelines.
- Cardiac shortening fraction ≥ 30% by echocardiogram or ejection fraction \>50% by MUGA. 6 Participants with combined bone marrow and testicular relapse are eligible assuming orchiectomy is performed prior to...
- Any history of prior or ongoing hepatic SOS or prior liver failure [defined as severe acute liver injury with encephalopathy and impaired synthetic function (INR of ≥1.5)].
- Prior allo-HSCT or CAR T-cell therapy.
- Isolated extramedullary leukemia.
- Philadelphia-chromosome positive ALL, ie. BCR-ABL/t(9;22) present.
- Prior therapy with a calicheamicin-conjugated antibody (eg, InO or gemtuzumab ozogamicin).
- Participants with active, uncontrolled bacterial, fungal, or viral infection.
- Hypersensitivity/allergy to both PEG-ASP and Erwinia-ASP
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Austria
- Brussels, Bruxelles-capitale, Région de, Belgium
- Ghent, Oost-vlaanderen, Belgium
- Leuven, Vlaams-brabant, Belgium
- Brno, Brno-město, Czechia
- Prague, Czechia
- Copenhagen, Capital Region, Denmark
- Helsinki, Finland
- Nice, Alpes-maritimes, France
- Strasbourg, Alsace, France
- Bordeaux, Aquitaine, France
- Toulouse, Haute-garonne, France
- Montpellier, Hérault, France
- Vandœuvre-lès-Nancy, Meurthe-et-moselle, France
- Lille, NORD, France
- Paris, Paris, France
- Lyon, France
- Nantes, France
- Paris, France
- Rennes, France
+ 47 more site(s).
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 study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, Austria; Brussels, Bruxelles-capitale, Région de, Belgium; Ghent, Oost-vlaanderen, Belgium; Leuven, Vlaams-brabant, Belgium; Brno, Brno-město, Czechia; Prague, Czechia and 61 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.