Feasibility and Effectiveness of Inotuzumab Ozogamicin in B-Cell Acute Lymphoblastic Leukemia (ALL2418)

December 31, 2021 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy
        • Recruiting
        • Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona- Sod Clinica Ematologica
        • Contact:
          • Olivieri
      • Ascoli Piceno, Italy
        • Recruiting
        • Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia
        • Contact:
      • Bergamo, Italy
        • Recruiting
        • Asst Papa Giovanni Xxiii - Ospedale Di Bergamo - Sc Ematologia
        • Contact:
      • Bologna, Italy
      • Bolzano, Italy
        • Recruiting
        • As Dell'Alto Adige, Ospedale Centrale Di Bolzano - Ematologia E Centro Trapianto Midollo Osseo
        • Contact:
          • Mosna
        • Principal Investigator:
          • Federico Mosna
      • Brescia, Italy
        • Recruiting
        • Asst Degli Spedali Civili Di Brescia - Uo Ematologia
        • Contact:
      • Cuneo, Italy
      • Genova, Italy
        • Recruiting
        • Irccs Aou San Martino - Genova - Uo Clinica Ematologica
        • Contact:
          • Lemoli
      • Lecce, Italy
        • Recruiting
        • Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia
        • Principal Investigator:
          • Nicola Di Renzo
      • Meldola, Italy
        • Recruiting
        • I.R.S.T. Srl Irccs - Meldola - Sc Oncologia Medica
        • Contact:
          • Cangini
        • Principal Investigator:
          • Delia Cangini
      • Mestre, Italy
      • Milano, Italy
      • Milano, Italy
      • Milano, Italy
        • Recruiting
        • Istituto Europeo Di Oncologia Irccs - Milano - Divisione Di Oncoematologia
        • Contact:
          • Todisco
        • Principal Investigator:
          • Elisabetta Todisco
      • Napoli, Italy
        • Recruiting
        • Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo
        • Contact:
      • Palermo, Italy
        • Recruiting
        • Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
        • Principal Investigator:
          • Antonino Mulè
        • Contact:
          • Mulè
      • Pavia, Italy
        • Recruiting
        • Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia
        • Contact:
          • Zappasodi
        • Principal Investigator:
          • Patrizia Zappasodi
      • Pescara, Italy
        • Recruiting
        • Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
        • Contact:
          • Spadano
        • Principal Investigator:
          • Antonio Spadano
      • Reggio Calabria, Italy
        • Recruiting
        • Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli" Po E. Morelli - Reggio Calabria - Uoc Ematologia
        • Contact:
      • Rimini, Italy
        • Recruiting
        • Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia
        • Contact:
          • Mianulli
        • Principal Investigator:
          • Anna Maria Mianulli
      • Roma, Italy
        • Recruiting
        • Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
        • Principal Investigator:
          • Sabina Chiaretti
        • Contact:
          • Chiaretti
      • Roma, Italy
        • Recruiting
        • Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia
        • Contact:
          • De Fabritiis
      • Salerno, Italy
        • Recruiting
        • Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche
        • Contact:
          • Selleri
        • Principal Investigator:
          • Carmine Selleri
      • San Giovanni Rotondo, Italy
        • Recruiting
        • Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
      • Siena, Italy
        • Recruiting
        • Aou Senese - Uoc Ematologia E Trapianti
        • Contact:
          • Bocchia
      • Torino, Italy
        • Recruiting
        • Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2
        • Contact:
          • Audisio
      • Treviso, Italy
        • Recruiting
        • Unità Operativa Di Ematologia - Presidio Ospedaliero Di Treviso - Azienda Ulss N.2 Marca Trevigiana
        • Contact:
          • Endri
        • Principal Investigator:
          • Mauro Endri
      • Udine, Italy
        • Recruiting
        • Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica
        • Contact:
          • Candoni
        • Principal Investigator:
          • Anna Candoni
      • Verona, Italy
        • Recruiting
        • Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
        • Contact:
          • Bonifacio
      • Vicenza, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Cohort 1 will entroll 38 Ph+ patients
Drug: Inotuzumab Ozogamicin (IO)

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.

Drug: Inotuzumab Ozogamicin (IO)
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.
Experimental: Cohort 2
Cohort 2 will enroll 38 Ph- patients
Drug: Inotuzumab Ozogamicin (IO)

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.

Drug: Inotuzumab Ozogamicin (IO)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients obtaining a negative Minimal Residual Disease (MRD)
Time Frame: Two years after study entry.
Two years after study entry.

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients alive
Time Frame: Two years from start of treatment.
Two years from start of treatment.
Number of adverse events in MRD positive patients
Time Frame: Two years after study entry.
Two years after study entry.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

  • Study Chair: Giovanni Martinelli, Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST Italy
  • Study Director: Fabio Ciceri, Istituto S. Raffaele, Milan, Italy Giuseppe Saglio, Institute of Hematology, Ospedale Mauriziano, Turin, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2019

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

July 25, 2018

First Submitted That Met QC Criteria

July 31, 2018

First Posted (Actual)

August 1, 2018

Study Record Updates

Last Update Posted (Actual)

January 4, 2022

Last Update Submitted That Met QC Criteria

December 31, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALL2418
  • 2018-003006-32 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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