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Acute Lymphoid LeukemiaPhase 2ALL2418NCT03610438

Feasibility and Effectiveness of Inotuzumab Ozogamicin in B-Cell Acute Lymphoblastic Leukemia

A Phase 2 study testing Inotuzumab Ozogamicin (IO) in people with Acute Lymphoid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 30 sites in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a multi-center, phase 2A exploratory study of feasibility and effectiveness of Inotuzumab Ozagomicin in adult patients with Acute Lymphoid Leukemia (ALL) with positive minimal residual disease before any hematopoietic stem cell transplantation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Lymphoid Leukemia
What is being tested?
Inotuzumab Ozogamicin (IO)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
30 sitesItaly
Study dates
30 Oct 2019to Oct 2026
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

  • Ph+ ALL with p190 or p210 detectable and measurable (at least 10-4 x10000 ABL) after at least 3 months of any therapy, or the failure of at least 2 TKI.
  • Ph- ALL with detectable and measurable IG specific transcript after at least 2 courses of previous therapy.
  • Age ≥ 18 years old.
  • ECOG ≤ 2.

Who cannot join

  • More than 5% of BM blasts.
  • WHO performance status ≤ 50% (Karnofsky) or ≥ 3 (ECOG).
  • Active HBV or HCV hepatitis, or AST/ALT ≥ 2.5 x ULN and bilirubine ≥ 1.5 x ULN.
  • Evidence of liver fibrosis, portal hypertension or other clinically relevant liver abnormalities at screening liver ultrasonography.
  • History of alcohol abuse.
  • Burkitt lymphoma and active CNS leukemia. Patients with previuos neurological toxicitiy as well co-morbidity will be carefully evaluated for enrolment.
Show all 19Show fewer
  • Ongoing or active infections.
  • Uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL). Clinically significant, uncontrolled, or active cardiovascular disease.
  • Uncontrolled hypertension (diastolic blood pressure >90 mm Hg; systolic >140 mm Hg). Patients with hypertension should be under treatment on study entry to effect blood pressure control.
  • Creatinine level > 2.5mg/dl or Glomerular Filtration Rate (GFR) < 20 ml/min or proteinuria > 3.5 g/day.
  • Documented inherited protrombotic disorders
  • Patients who have received any investigational drug ≤ 4 weeks.
  • Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
  • Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention or with a life expectancy due to other malignancy <6 months.
  • Patients that have received Inotuzumab or Anti CD22 directed therapies before
  • Patients with known hereditary coagulopathy
  • Patient that received during their life diagnosis of VOD or had ongoing VOD
  • Patients who are pregnant or breastfeeding and adults of reproductive potential not employing an effective method of birth control (women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of induction therapy). Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 4 months following discontinuation of study drugs.
  • Patients unwilling or unable to comply with the protocol.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

Italy30 sites

  • Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona- Sod Clinica Ematologica

    Ancona

  • Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia

    Ascoli Piceno

  • Asst Papa Giovanni Xxiii - Ospedale Di Bergamo - Sc Ematologia

    Bergamo

  • Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia

    Bologna

  • As Dell'Alto Adige, Ospedale Centrale Di Bolzano - Ematologia E Centro Trapianto Midollo Osseo

    Bolzano

  • Asst Degli Spedali Civili Di Brescia - Uo Ematologia

    Brescia

  • Aso S. Croce E Carle - Cuneo - Sc Ematologia

    Cuneo

  • Irccs Aou San Martino - Genova - Uo Clinica Ematologica

    Genova

  • Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia

    Lecce

  • I.R.S.T. Srl Irccs - Meldola - Sc Oncologia Medica

    Meldola

  • Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia

    Mestre

  • Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia

    Milan

  • Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia

    Milan

  • Istituto Europeo Di Oncologia Irccs - Milano - Divisione Di Oncoematologia

    Milan

  • Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo

    Naples

  • Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo

    Palermo

  • Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia

    Pavia

  • Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica

    Pescara

  • Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli" Po E. Morelli - Reggio Calabria - Uoc Ematologia

    Reggio Calabria

  • Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia

    Rimini

  • Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia

    Roma

  • Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia

    Roma

  • Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche

    Salerno

  • Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia

    San Giovanni Rotondo

  • Aou Senese - Uoc Ematologia E Trapianti

    Siena

  • Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2

    Torino

  • Unità Operativa Di Ematologia - Presidio Ospedaliero Di Treviso - Azienda Ulss N.2 Marca Trevigiana

    Treviso

  • Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica

    Udine

  • Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia

    Verona

  • Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia

    Vicenza

Other trials in Italy

About this study

Official title: A Phase IIA Study of Feasibility and Effectiveness of Inotuzumab Ozogamicin (IO) in Adult Patients With B-Cell Acute Lymphoblastic Leukemia With Positive Minimal Residual Disease Before Any Hematopoietic Stem Cell Transplantation

This is a multi-center, phase 2A exploratory study of feasibility and effectiveness of Inotuzumab Ozagomicin in adult patients with Acute Lymphoid Leukemia (ALL) with positive minimal residual disease before any hematopoietic stem cell transplantation.

The study is divided in two cohorts; cohort 1 will enroll 38 Ph+ patients, cohort 2 will enroll 38 Ph- patients, as defined with statistical analysis. The two cohorts will have the same treatment, with the exception of short term and long term maintenance.

Being tested
Inotuzumab Ozogamicin (IO)
Keywords
Acute Lymphoid Leukemia, Inotuzumab Ozogamicin
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

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

  • Inotuzumab Ozogamicin (IO)Drug

    After course 1 MRD will be evaluated:

    • patients MRD negative will enter into short maintenance or long maintenance according to investigator choice. After 4 to 12 weeks in short maintenance patient will undergo SCT, otherwise, patients will enter long maintenance.

  • Inotuzumab Ozogamicin (IO)Drug

    After course 2 MRD will be evaluated; patients MRD negative will enter into short maintenance or long maintenance by investigator choice. After 4 to 12 weeks in short maintenance patient will undergo SCT, otherwise, patients will enter long maintenance.

Study groups in NCT03610438
Study groupRoleWhat they receive
Cohort 1ExperimentalCohort 1 will entroll 38 Ph+ patients
Receives: Drug: Inotuzumab Ozogamicin (IO)
Cohort 2ExperimentalCohort 2 will enroll 38 Ph- patients
Receives: Drug: Inotuzumab Ozogamicin (IO)

What is being measured

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

  1. Number of patients obtaining a negative Minimal Residual Disease (MRD)

    Measured: Two years after study entry.

Secondary outcomes (2)

  1. Number of patients alive

    Measured: Two years from start of treatment.

  2. Number of adverse events in MRD positive patients

    Measured: Two years after study entry.

Timeline

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

  1. First posted1 Aug 2018
  2. Study start30 Oct 2019
  3. Primary completion15 Jul 2026
  4. Study completionOct 2026 (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
Non-randomised
Intervention model
Parallel groups
Model description
The study is divided in two cohorts; cohort 1 will enroll 38 Ph+ patients, cohort 2 will enroll 38 Ph- patients, as defined with statistical analysis. The two cohorts will have the same treatment, with the exception of short term and long term maintenance.
Masking
None (open label)
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03610438
Sponsor's protocol ID
ALL2418
Other IDs
2018-003006-32, 2018
Acronym
ALL2418
Status last verified
Jul 2026
First submitted
25 Jul 2018
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Inotuzumab Ozogamicin (IO) in people with Acute Lymphoid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 30 sites in Italy.

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 4 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Italy. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients obtaining a negative Minimal Residual Disease (MRD) (time frame: Two years after study entry.). 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 NCT03610438.

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 16 Jul 2026.

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