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Acute Lymphobkastic LeukemiaPhase 2INOPOSALONCT07862946

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

A Phase 2 study testing Inotuzumab Ozogamicin (IO) in people with Acute Lymphobkastic Leukemia and Adult, run by PETHEMA Foundation at 10 sites in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Lymphobkastic Leukemia, Adult
What is being tested?
Inotuzumab Ozogamicin (IO)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
10 sitesSpain
Study dates
30 Oct 2026to 30 Oct 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • Prior exposure to inotuzumab ozogamicin or known hypersensitivity to inotuzumab ozogamicin or to any of its excipients.
  • Ph-positive lymphoblastic leukemia
  • Cord blood HSCT.
  • Creatinine clearance <30 ml/minute.
  • Bilirubin, GOT and GPT > 2 times the upper limit of the institution's reference values.
  • History of previous liver disease or hepatic veno-occlusive disease/sinusoid obstruction syndrome.
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  • 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
  • Graft-versus-host disease prophylaxis with sirolimus at enrolment that cannot be discontinued prior to initiation of trial treatment.
  • Absence of haematological recovery
  • Uncontrolled concomitant disease (cardiac, renal, pulmonary, psychiatric).
  • Uncontrolled non-hematological tumor
  • 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.
  • 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.

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Alfonso Santiago contact

+34 91 626 62 32

asm@fundacionpethema.es

Arancha Bermúdez contact

maria.bermudez@scsalud.es

10 sites in 1 country

Spain10 sites

  • ICO-Hospital Germans Trias i Pujol

    Badalona

    Anna Torrent, +344651200, atorrent@iconcologia.net

  • H. de la Santa Creu I Sant Pau

    Barcelona

  • C. H. Gregorio Marañón

    Madrid

  • H. 12 de Octubre

    Madrid

  • C. H. Regional de Málaga , H. General

    Málaga

  • C. Asistencial U. de Salamanca

    Salamanca

  • H Donostia

    San Sebastián

  • H. Marqués de Valdecilla

    Santander

  • Complejo Hosp. Regional Virgen del Rocío

    Seville, 41013

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

About this study

Official title: 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:

Read more
  • 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.

Read the detailed description

This is a single arm study in which participants with high-risk B-cell precurdsor acute lymphoblastic leukemia (BCP ALL) enrollled in the immunochemotherapy schedule according to PETHEMA ALL-2025 protocol will receive Inotuzimab Ozogamicin as post-transplantation therapy to prevent relapse. The relapse rate of the participants will be compared to that of high-risk BCP ALL patients receiving transplantation within the PETHEMA ALL-2025 protocol. In addition, the presence of adverse events and severe adverse events will also be monitored in order to know if this treatment is as safe as or comparable to that of patients not receiving this drug. A safety analysis will be performed in the first 5 patients with special consideration of haematological and hepatic toxicity.

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. This regimen is intended as post-allo-HSCT relapse prophylaxis/maintenance rather than treatment of active relapsed disease. Patients will be monitored upto 24 months after the last drug infusion (month 3, 6, 9, 12, 18, 24).

Being tested
Inotuzumab Ozogamicin (IO)
Keywords
Inotuzomab ozogamicin, B-cell acute lymphoblatic leukemia, allogeneic stem cell trasnplantation, relapse
Medical subject headings
Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inotuzumab Ozogamicin (IO)Drug

    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 groups in NCT07862946
Study groupRoleWhat they receive
Inotuzumab OzogamicinExperimentalNot described
Receives: Drug: Inotuzumab Ozogamicin (IO)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of Inotuzumab Ozogamicin (InO) in the prevention of relapse in terms of the relapse rate

    Evaluation of the efficacy of InO in terms of relapse rate, defined as percentage of patients who experience a relapse after achieving complete remission.

    Measured: 24 months

  2. Efficacy of InO in the prevention of relapse in terms of the cumulative incidence of relapse (CIR)

    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.

    Measured: 24 months

  3. Efficacy of InO in the prevention of relapse in terms of the disease-free survival (DFS).

    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.

    Measured: 24 months

Secondary outcomes (4)

  1. Safety profile of treatment with InO after allogeneic hematopoietic stem cell trasnplantation (allo-HSCT) in terms of side effects, adverse events (AEs) and serious AEs (SAEs) related to treatment

    The safety profile of the treatment will be assessed based on:

    • Incidence of AEs.
    • Percentage of patients discontinuing therapy due to AEs.
    • Percentage of patients requiring dose modifications due to AEs.
    • Incidence of SAEs.
    • Changes in laboratory analysis from the hematology and blood chemistry panel.
    • Incidence of deaths and primary cause of death. A safety analysis will be performed in the first five patients with special consideration of haematological and hepatic toxicity.

    Measured: 24 months

  2. Centralized study the minimal residual disease (MRD) in bone marrow (BM)

    MRD will be centrally analized in BM prior to drug administration, as well as at 3-, 6-, 9-, 12-, 18- and 22-months post allo-HSCT by Next Generation Flow Cytometry. Negative MRD will be considered when there is <0.01% of leukemic cells among all cell counts.

    Measured: 22 months

  3. Analysis of the immune reconstitution in peripheral blood

    Analysis of the immune reconstitution in peripheral blood prior to drug administration and at 3-, 6-, 9-, 12-, 18- and 22-months post allo-HSCT, evaluated by immunophenotypic study (NGF) of specific markers of B-cells, T-cells and myeloid cells, among others.

    Measured: 22 months

  4. Analyse the cumulative incidence of graft failure and acute and chronic graft-versus-host disease (GVHD).

    Analysis of the cumulative incidence of graft failure, defined as time interval from allo-HSCT to graft failure (failure to achieve sustained engraftment of donor cells). Cumulative incidence of acute GVHD (aGVHD), defined as time interval from allo-HSCT to aGVHD, staged and graded according to the MAGIC criteria previously published. Cumulative incidence of chronic GVHD (cGVHD) as time interval from allo-HSCT to cGVHD, based on the NIH criteria previously published.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2026
  2. Study start30 Oct 2026 (estimated)
  3. Primary completion30 Oct 2030 (estimated)
  4. Study completion30 Oct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07862946
Sponsor's protocol ID
INOPOSALO
Acronym
INOPOSALO
Status last verified
Oct 2026
First submitted
2 Oct 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Inotuzumab Ozogamicin (IO) in people with Acute Lymphobkastic Leukemia and Adult, run by PETHEMA Foundation at 10 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alfonso Santiago (+34 91 626 62 32, asm@fundacionpethema.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of Inotuzumab Ozogamicin (InO) in the prevention of relapse in terms of the relapse rate (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07862946.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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