Inotuzumab ozogamicin after stem cell transplant in adults with high-risk acute lymphoblastic leukemia
Tests inotuzumab ozogamicin to help prevent relapse after transplant in adults with acute lymphoblastic leukemia.
Plain-language title generated from the registry record
Registry title: Inotuzumab as Post-Trasplantation Therapy for Adult High-risk B-cell Precursor Acute Lymphoblastic Leukemia
Key facts
- Where
- Badalona, Barcelona, Madrid, Málaga, Salamanca, San Sebastián, Santander, Seville, and Valencia, SpainSee the 10 sites
- Phase
- Phase 2
Where in Spain
- Ico Hospital Germans Trias I PujolBadalona, SpainNo longer taking part
- H. de la Santa Creu I Sant PauBarcelona, SpainNo longer taking part
- C. H. Gregorio MarañónMadrid, SpainNo longer taking part
- H. 12 de OctubreMadrid, SpainNo longer taking part
- C. H. Regional de Málaga , H. GeneralMálaga, SpainNo longer taking part
- C. Asistencial U. de SalamancaSalamanca, SpainNo longer taking part
- H DonostiaSan Sebastián, SpainNo longer taking part
- H. Marqués de ValdecillaSantander, SpainNo longer taking part
- Complejo Hosp. Regional Virgen del RocíoSeville, SpainNo longer taking part
- Hospital Universitari i Politécnic La FeValencia, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- PETHEMA Foundation
- Trial code
- NCT07862946
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
Multicenter, Open Label, Phase II Clinical Trial of Inotuzumab Ozogamicin as Prophylaxis for Relapse in Patients With High-risk Acute B-cell Precursor Acute Lymphoblastic Leukaemia After Allogeneic Stem Cell Haemotopoietic Transplantation
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.
Inclusion: Patient is, in the investigator's opinion, willing and able to adhere/comply with visit schedule and other protocol requirements; Patient must be able to understand the study procedures; Patients aged ≥18 years at the time of signing the informed consent form; Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2; Patient with CD22-positive high risk ALL according to any of the following criteria:; 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); Patients who are in first CR at the time of transplantation, irrespective of MRD status as assessed by immunophenotypic study; Allo-HSCT from an HLA-identical, mismatched or haploidentical sibling or unrelated donor, with myeloablative, reduced toxicity or non-myeloablative conditioning; 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: Prior exposure to inotuzumab ozogamicin or known hypersensitivity to inotuzumab ozogamicin or to any of its excipients; History of previous liver disease or hepatic veno-occlusive disease/sinusoid obstruction syndrome; Graft-versus-host disease prophylaxis with sirolimus at enrolment that cannot be discontinued prior to initiation of trial treatment; Uncontrolled concomitant disease (cardiac, renal, pulmonary, psychiatric); Active hepatitis B or C; Fungal infection or relevant uncontrolled infection; Active grade 3-4 acute graft-versus-host disease or acute or chronic hepatic graft-versus- host disease grade ≥2; Any serious medical condition or psychiatric illness that would interfere in understanding of the informed consent form; Any serious medical condition that places the subject at an unacceptable risk if he or she participates in this study; Creatinine clearance <30 ml/minute; Bilirubin, GOT and GPT > 2 times the upper limit of the institution's reference values; Ph-positive lymphoblastic leukemia; Cord blood HSCT; Absence of haematological recovery; Uncontrolled non-hematological tumor; 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.