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.
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
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.
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, Sevilla, 41013
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, 46026
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).
- Conditions
- Acute Lymphobkastic Leukemia, Adult
- 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 group | Role | What they receive |
|---|---|---|
| Inotuzumab Ozogamicin | Experimental | Not described Receives: Drug: Inotuzumab Ozogamicin (IO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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)
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
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
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
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.
- First posted7 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Oct 2030 (estimated)
- Study completion30 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphobkastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arancha Bermúdez, Study chair, Hospital Marqués de Valdecilla
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
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No