Inotuzumab ozogamicin to help prevent relapse of acute lymphoblastic leukaemia after stem cell transplant
Tests inotuzumab ozogamicin to prevent relapse in adults with high-risk leukaemia after transplant.
Plain-language title generated from the registry record
Registry title: A phase II clinical trial of inotuzumab ozogamicin as prophylaxis for relapse in patients with lymphoblastic leukaemia after allogeneic stem cell haemotopoietic transplantation
Key facts
- Where
- Badalona, Barcelona, Donostia, Madrid, Málaga, Salamanca, Santander, Sevilla, and Valencia, SpainSee the 10 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with high-risk CD22-positive B-cell acute lymphoblastic leukaemia who are in first remission and have had a stem cell transplant from a donor, with stable engraftment.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- High-risk CD22-positive acute lymphoblastic leukaemia, in first complete remission at the time of the donor stem cell transplant, with stable blood cell recovery after the transplant (neutrophils >1000/μL for at least 3 consecutive days, platelets >50000/μL for 7 days without transfusions, donor chimerism >90%).
- Earlier treatment
- Must have had a donor (allogeneic) stem cell transplant from a sibling or unrelated donor. Must not have had inotuzumab ozogamicin before.
- Biomarker or test result
- CD22-positive leukaemia. Ph-positive leukaemia cannot join.
Main reasons for not taking part
- Previous inotuzumab ozogamicin
- Previous liver disease or hepatic veno-occlusive disease
- Active hepatitis B or C
- Active severe graft-versus-host disease (grade 3-4)
- Pregnant or breastfeeding, or planning pregnancy
Read by machine on 9 November 2026.
Where in Spain
- Institut Catala d'OncologiaBadalona, SpainNot yet recruiting
- Hospital de la Santa Creu i Sant PauBarcelona, SpainNot yet recruiting
- Hospital Universitario DonostiaDonostia, SpainNot yet recruiting
- Hospital General Universitario Gregorio MarañónMadrid, SpainNot yet recruiting
- Hospital Universitario 12 de OctubreMadrid, SpainNot yet recruiting
- Hospital Universitario Regional de MálagaMálaga, SpainNot yet recruiting
- Complejo Asistencial Universitario de SalamancaSalamanca, SpainNot yet recruiting
- Hospital Universitario Marqués de ValdecillaSantander, SpainNot yet recruiting
- University Hospital Virgen Del Rocio S.L.Sevilla, SpainNot yet recruiting
- Hospital Universitario Y Politecnico La FeValencia, SpainNot yet recruiting
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?
Contact the study team: see the registry record
Print a page for my doctorTrial details
- Who runs it
- Fundacion PETHEMA
- Trial code
- EU 2026-525964-17-00
- Record updated
- 15 September 2026
- Original description
To evaluate the efficacy of InO in the prevention of relapse after allo-HSCT in adult patients with high-risk BCP-ALL treated according to the PETHEMA ALL- 2025 protocol in terms of the relapse rate, the CIR, and the DFS.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
To evaluate the efficacy of InO in the prevention of relapse after allo-HSCT in adult patients with high-risk BCP-ALL treated according to the PETHEMA ALL- 2025 protocol in terms of the relapse rate, the CIR, and the DFS.
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: 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: Prior exposure to inotuzumab ozogamicin; 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; Bilirubin, GOT and GPT > 2 times the upper limit of the institution's reference values; Creatinine clearance <30 ml/minute; Ph-positive lymphoblastic leukemia; Absence of haematological recovery; Uncontrolled non-hematological tumor; Women who are pregnant or breastfeeding, or who intends to become pregnant during participation in the study, and men and women of reproductive potential who are not using effective contraceptive methods (double barrier method, intrauterine device, oral contraception); Cord blood HSCT.