Post-Frontline Sequential Treatment of Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

October 10, 2022 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

Ancillary Observational Study of Post-Frontline Sequential Treatment of Adult Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Patients With Dasatinib and the Bispecific Monoclonal Antibody Blinatumomab

The primary objective of the present study is to evaluate the long-term observation, in terms of overall survival, of adult Ph+ ALL patients treated frontline with the sequential administration of dasatinib and the bispecific monoclonal antibody blinatumomab according to GIMEMA protocol LAL2116.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Since the treatment after dasatinib and blinatumomab is not uniform and highly dependent on medical decisions, the primary aim of this ancillary trial is to evaluate the long-term follow-up of patients enrolled in the GIMEMA 2116, in terms of overall survival (OS). Furthermore, the secondary objectives are the collection of data and survival outcomes relative to the therapeutic choices carried out after dasatinib and blinatumomab (i.e. allo-SCT, autologous transplant, TKI maintenance, etc), duration of CMR, DFS, long-term safety profile. A correlation of survival outcomes (OS, DFS, etc) with the clinical and biological findings will be carried out with data collected at diagnosis and during the follow-up within the LAL2116 trial.

Study Type

Observational

Enrollment (Anticipated)

60

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
      • Bari, Italy
        • Recruiting
        • Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
        • Contact:
      • Bergamo, Italy
        • Recruiting
        • Asst Papa Giovanni Xxiii - Ospedale Di Bergamo - Sc Ematologia
      • Brescia, Italy
        • Recruiting
        • Asst Degli Spedali Civili Di Brescia - Uo Ematologia
      • Catania, Italy
        • Recruiting
        • Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania
        • Contact:
      • Firenze, Italy
        • Recruiting
        • Aou Careggi - Firenze - Sod Ematologia
        • Contact:
      • Lecce, Italy
        • Recruiting
        • Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia
      • Mestre, Italy
        • Recruiting
        • Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia
      • Milano, Italy
        • Recruiting
        • Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
      • Novara, Italy
        • Recruiting
        • Aou Maggiore Della Carita' Di Novara - Scdu Ematologia
        • Contact:
      • Orbassano, Italy
        • Recruiting
        • Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia
        • Contact:
      • Pagàni, Italy
        • Recruiting
        • Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia
        • Contact:
      • Parma, Italy
        • Recruiting
        • Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo
        • Contact:
      • Perugia, Italy
        • Recruiting
        • Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo
      • Roma, Italy
        • Recruiting
        • Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
        • Contact:
      • Roma, Italy
        • Recruiting
        • Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali
      • Rome, Italy
        • Not yet recruiting
        • Dipartimento di Biotecnologie Cellulari ed Ematologia "Sapienza" Università degli Studi di Roma
      • Verona, Italy
        • Recruiting
        • Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All eligible patients enrolled in the LAL2116 and who have completed the 12 months follow-up will be included in this study (a maximum of 60 patients).

Description

Inclusion Criteria:

  • Study LAL2217 Informed Consent signature.
  • Patients enrolled in the GIMEMA LAL2116 protocol and who have completed the 12 months follow-up

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All patients
All eligible patients enrolled in the GIMEMA LAL2116 study who have completed 12 months follow-up will be included in this group.
Drug: Dasatinib and blinatumomab
Patients treated frontline with the sequential administration of dasatinib and the bispecific monoclonal antibody blinatumomab according to the protocol LAL2116

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients alive
Time Frame: At five years since study entry
At five years since study entry

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of therapeutic choices taken after dasatinib and blinatumomab (induction/consolidation) according to individual medical decisions and clinical practice.
Time Frame: At five years from study entry
Characteristics of these choices
At five years from study entry
Number of days in complete molecular remission.
Time Frame: At five years from study entry
Duration of remission
At five years from study entry
Number of patients in disease-free survival
Time Frame: At five years from study entry
At five years from study entry
Number of adverse events
Time Frame: At five years from study entry
Long-term safety profile
At five years from 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: Roberto Foà, Prof., Dipartimento di Biotecnologie Cellulari ed Ematologia "Sapienza" Università degli Studi di Roma

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)

May 10, 2019

Primary Completion (ANTICIPATED)

May 1, 2024

Study Completion (ANTICIPATED)

May 1, 2024

Study Registration Dates

First Submitted

October 19, 2017

First Submitted That Met QC Criteria

October 23, 2017

First Posted (ACTUAL)

October 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAL2217

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Acute Lymphoblastic Leukemia

Clinical Trials on Dasatinib and blinatumomab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe