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

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ClinicalTrials.gov Identifier: NCT03318770
Recruitment Status : Not yet recruiting
First Posted : October 24, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief Summary:
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.

Condition or disease Intervention/treatment
Acute Lymphoblastic Leukemia Drug: Dasatinib and blinatumomab

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: 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
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023


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




Primary Outcome Measures :
  1. Number of patients alive [ Time Frame: At five years since study entry ]

Secondary Outcome Measures :
  1. 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

  2. Number of days in complete molecular remission. [ Time Frame: At five years from study entry ]
    Duration of remission

  3. Number of patients in disease-free survival [ Time Frame: At five years from study entry ]
  4. Number of adverse events [ Time Frame: At five years from study entry ]
    Long-term safety profile



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03318770


Contacts
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Contact: Paola Fazi +39 06 70390514 p.fazi@gimema.it
Contact: Enrico Crea +39 06 70390514 e.crea@gimema.it

Locations
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Italy
Dipartimento di Biotecnologie Cellulari ed Ematologia "Sapienza" Università degli Studi di Roma Not yet recruiting
Rome, Italy
Contact: Roberto Foà         
Principal Investigator: Roberto Foà         
Sub-Investigator: Sabina Chiaretti         
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
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Study Chair: Roberto Foà, Prof. Dipartimento di Biotecnologie Cellulari ed Ematologia "Sapienza" Università degli Studi di Roma

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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT03318770     History of Changes
Other Study ID Numbers: LAL2217
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Acute Lymphoblastic Leukemia
adult
dasatinib
blinatumomab
LAL2116
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Dasatinib
Blinatumomab
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action