Ireland
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Starting soon Phase 2

Inotuzumab as Post-Trasplantation Therapy for Adult High-risk B-cell Precursor Acute Lymphoblastic Leukemia

NCT07862946 · tracked via the Priya Life Science Spain tracker
Phase
Phase 2
Started
2026-10-30
Last updated
2026-10-07

Condition(s) studied

Acute Lymphobkastic LeukemiaAdult

Investigational drug(s) / intervention(s)

Inotuzumab Ozogamicin (IO) →

Inotuzumab Ozogamicin (IO): Three doses of 0,5mg/m2 of Inotuzumab Ozogamicin will be given to participants at day +70 post-transplantation and a minimum interval of 30 days between consecutive administrations. All patients will receive treatment until treatment is completed, unacceptable toxicity, disease progression, patient withdrawal, loss of follow-up, end of study, study completion, or death, whichever is first.

Study summary

The goal of this clinical trial is to learn if Inotuzumab Ozogamicin works to prevent relapses after transplantation in adult high-risk B-cell precursor acute lymphoblastic leukemia treated with the PETHEMA ALL-2025 protocol.

The main questions it aims to answer are:

* Do patients receiving Inotuzumab ozogamicin post-transplantation suffer less relapses than those patients not receiving this therapy (control group) within the ALL-2025 protocol?
* Do patients receiving Inotuzumab ozogamicin show more adverse events and severe adverse events related with this treatment than those patients no receiving this intervention (control group)? Researchers will compare the relapse rate between patients receiving Inotuzumab Ozogamicin post-transplantation and patients not receiving Inotuzumab Ozogamicin post-trasnplantation within the ALL-2025 protocol.

Participants will receive 3 cycles of Inotuzumab Ozogamicin therapy. Treatment will be initiated from day +70 post-transplantation and a minimum interval of 30 days between consecutive administrations.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patient is, in the investigator's opinion, willing and able to adhere/comply with visit schedule and other protocol requirements. 2. Patient must be able to understand the study procedures. 3. Patients aged ≥18 years at the time of signing the informed consent form. 4. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2. 5. Patient with CD22-positive high risk ALL according to any of the following criteria: i. Definition of high risk ALL according to the PETHEMA LAL 2019 protocol criteria including MRD stratification at the end of induction and during treatment and adverse cytogenetics at diagnosis (hypodiploid karyotype, KMT2A (MLL) alterations, homozygous TP53 deletions/mutations, and IKZF1 and CDKN2A/B deletions). ii. Patients who are in first CR at the time of transplantation, irrespective of MRD status as assessed by immunophenotypic study. iii. Allo-HSCT from an HLA-identical, mismatched or haploidentical sibling or unrelated donor, with myeloablative, reduced toxicity or non-myeloablative conditioning. iv. Stable hematopoietic engraftment defined by neutrophils \>1000/μL for at least 3 consecutive days and platelets \>50000/μL for 7 days with transfusion independence and donor chimerism \>90% assessed in peripheral blood. Exclusion Criteria: 1. Prior exposure to inotuzumab ozogamicin or known hypersensitivity to inotuzumab ozogamicin or to any of its excipients. 2. Ph-positive lymphoblastic leukemia 3. Cord blood HSCT. 4. Creatinine clearance \<30 ml/minute. 5. Bilirubin, GOT and GPT \> 2 times the upper limit of the institution's reference values. 6. History of previous liver disease or hepatic veno-occlusive disease/sinusoid obstruction syndrome. 7. Active hepatitis B or C 8. Fungal infection or relevant uncontrolled infection. 9. Active grade 3-4 acute graft-versus-host disease or acute or chronic hepatic graft-versus- host disease grade ≥2 10. Graft-versus-host disease prophylaxis with sirolimus at enrolment that cannot be discontinued prior to initiation of trial treatment. 11. Absence of haematological recovery 12. Uncontrolled concomitant disease (cardiac, renal, pulmonary, psychiatric). 13. Uncontrolled non-hematological tumor 14. Any serious medical condition or psychiatric illness that would interfere in understanding of the informed consent form. 15. Any serious medical condition that places the subject at an unacceptable risk if he or she participates in this study. 16. Women who are pregnant or breastfeeding, or who intend to become pregnant during participation in the study, or women of childbearing potential who are unwilling or unable to use a highly effective contraceptive method during treatment and for at least 8 months after the last dose; and male participants with female partners of childbearing potential who are unwilling or unable to use a highly effective contraceptive method during treatment and for at least 5 months after the last dose.

Primary outcome measure(s)

  • Efficacy of Inotuzumab Ozogamicin (InO) in the prevention of relapse in terms of the relapse rate — 24 months
    Evaluation of the efficacy of InO in terms of relapse rate, defined as percentage of patients who experience a relapse after achieving complete remission.
  • Efficacy of InO in the prevention of relapse in terms of the cumulative incidence of relapse (CIR) — 24 months
    Evaluation of the efficacy of InO in terms of CIR, defined as time interval between the date of complete remission and the date of relapse, considering any death not related to relapse as a competing event.
  • Efficacy of InO in the prevention of relapse in terms of the disease-free survival (DFS). — 24 months
    Evaluation of the efficacy of InO in terms of DFS, defines as time interval between the date of complete remission and relapse, death from any cause or last follow-up.

Trial sites (10)

FacilityCityRegionStatus
Complejo Hosp. Regional Virgen del Rocío Seville Sevilla
Hospital Universitari i Politecnic La Fe Valencia Valencia
ICO-Hospital Germans Trias i Pujol Badalona Spain
H. de la Santa Creu I Sant Pau Barcelona Spain
C. H. Gregorio Marañón Madrid Spain
H. 12 de Octubre Madrid Spain
C. H. Regional de Málaga , H. General Málaga Spain
C. Asistencial U. de Salamanca Salamanca Spain
H Donostia San Sebastián Spain
H. Marqués de Valdecilla Santander Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07862946 on ClinicalTrials.gov ↗ ← All trials in Spain