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Targeted drug aims to clear hidden leukemia before transplant

NCT ID NCT03610438

Disease control Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This study tests whether the targeted drug inotuzumab ozogamicin can eliminate minimal residual disease (MRD) in adults with B-cell acute lymphoblastic leukemia (ALL) before they receive a stem cell transplant. Participants have either Philadelphia chromosome-positive or -negative ALL with detectable MRD after prior therapy. The goal is to see if the drug can make MRD undetectable, which may lead to better transplant outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
inotuzumab ozogamicin, an antibody-drug conjugate that targets cancer cells
What this could lead to
If successful, this approach could help more patients achieve a cancer-free state before a stem cell transplant, potentially improving long-term outcomes.
What could go wrong
This is an early-phase study with a small number of participants, so results may not apply broadly. The drug can cause serious side effects like liver damage and low blood cell counts.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 76 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2019

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia B-cell acute lymphoblastic leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute lymphoid leukemia

Contacts and locations

Locations

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

    Naples, Italy

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

    Palermo, Italy

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

    Salerno, Italy

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

    Torino, Italy

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

    Bologna, Italy

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

    Verona, Italy

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

    Ancona, Italy

  • Aou Senese - Uoc Ematologia E Trapianti

    Siena, Italy

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

    Ascoli Piceno, Italy

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

    Bolzano, Italy

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

    Lecce, Italy

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

    Pescara, Italy

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

    Roma, Italy

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

    Cuneo, Italy

  • Asst Degli Spedali Civili Di Brescia - Uo Ematologia

    Brescia, Italy

  • Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia

    Milan, Italy

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

    Bergamo, Italy

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

    Udine, Italy

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

    Mestre, Italy

  • Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia

    Vicenza, Italy

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

    Rimini, Italy

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

    San Giovanni Rotondo, Italy

  • Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia

    Pavia, Italy

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

    Reggio Calabria, Italy

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

    Meldola, Italy

  • Irccs Aou San Martino - Genova - Uo Clinica Ematologica

    Genova, Italy

  • Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia

    Milan, Italy

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

    Milan, Italy

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

    Treviso, Italy

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

    Roma, Italy

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