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D-ALBA Frontline Sequential Dasatinib and Blinatumomab in Adult Philadelphia Positive Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT02744768
Recruitment Status : Unknown
Verified March 2018 by Gruppo Italiano Malattie EMatologiche dell'Adulto.
Recruitment status was:  Recruiting
First Posted : April 20, 2016
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Study Description
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Brief Summary:
This study aims at exploring the activity of a frontline approach based on dasatinib plus steroids administration as induction treatment, followed by the infusion of Blinatumomab, in adult Ph+ ALL.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Drug: Dasatinib Drug: Blinatumomab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: D-ALBA Front-Line Sequential Treatment of Adult Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Patients With Dasatinib and the Bispecific Monoclonal Antibody Blinatumomab
Actual Study Start Date : May 31, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment

Adult Ph+ ALL (≥18 years old, with no upper age limit) patients will begin treatment with Dasatinib, 140 mg/day, from day 1 to day +84. Prednisone (PDN) will be administered from day -6 to day +0 (during which the presence of the BCR/ABL1 alteration will be established), at escalating doses up to 60 mg/m2; PDN will be continued up to day +24 and progressively tapered up to day +31.

HLA typing will be performed immediately after the diagnosis for eligible patients.

MRD will be evaluated by RT-PCR at fixed time points (days +22, +45, +57) during the induction and at day +85, the latter for molecular response evaluation.

 Drug: Dasatinib
Adult Ph+ ALL (≥18 years old, with no upper age limit) patients will begin treatment with Dasatinib, 140 mg/day, from day 1 to day +84.

Drug: Blinatumomab

Upon induction:

patients in CHR will receive Blinatumomab at a dose of 15 µg/m²/day as continuous intravenous infusion (CIVI) at a constant flow rate for four weeks, followed by a two-week infusion-free interval, defined as one treatment cycle. At least 2 cycles should be administered, up to a maximum of 5 cycles, if deemed necessary.


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients who achieve Minimal Residual Disease (MRD) negativity upon treatment [ Time Frame: After 11 months from study entry ]
    In particular, after 2 cycles of blinatumomab. Minimal Residual Disease (MRD) negativity is intended as Complete Molecular Remission (CMR)


Secondary Outcome Measures :
  1. Number of patients completing the 2 cycles of blinatumomab and alive in first complete hematologic remission (CHR) [ Time Frame: From day +85 at 12 months ]
  2. Number of patients at Complete Molecular Response (CMR) [ Time Frame: At day +22, +45, +57 and +85 from study entry ]
  3. Number of months of the CMR [ Time Frame: At 12 and 24 months ]
  4. Number of patients in Overall Survival (OS) [ Time Frame: At 12 and 24 months ]
  5. Number of grade >3 adverse events [ Time Frame: At 12 and 24 months ]

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

Inclusion Criteria:

  • Newly diagnosed adult B-precursor Ph+ ALL patients.
  • Age greater or equal to18 years,
  • Signed written informed consent according to ICH/EU/GCP and national local laws.
  • ECOG Performance Status 0 or 1 and/or WHO performance status less or equal to 2.

  • Renal and hepatic function as defined below:

    • AST (GOT), ALT (GPT), and AP <2 x upper limit of normal (ULN).
    • Total bilirubin <1.5 x ULN.
    • Creatinine clearance equal or greater than 50 mL/min.

  • Pancreatic function as defined below:

    • Serum amylase less or equal to 1.5 x ULN
    • Serum lipase less or equal to1.5 x ULN.
  • Normal cardiac function.
  • Negative HIV test, negative HBV DNA and HCV RNA.
  • Negative pregnancy test in women of childbearing potential.
  • Bone marrow specimen from primary diagnosis available.

Exclusion Criteria:

  • History of or current relevant CNS pathology (current ≥grade 2 epilepsy, seizure, paresis, aphasia, clinically relevant apoplexia, severe brain injuries, dementia, Parkinson's disease, organic brain syndrome, psychosis).

  • Impaired cardiac function, including any one of the following:

    • LVEF <45% as determined by MUGA scan or echocardiogram.
    • Complete left bundle branch block.
    • Use of a cardiac pacemaker.
    • ST depression of >1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads.
    • Congenital long QT syndrome.
    • History of or presence of significant ventricular or atrial arrhythmia.
    • Clinically significant resting bradycardia (<50 beats per minute).
    • QTc >450 msec on screening ECG (using the QTcF formula).
    • Right bundle branch block plus left anterior hemiblock, bifascicular block.
    • Myocardial infarction within 3 months prior to starting Dasatinib.
    • Angina pectoris.
  • Other clinically significant heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen).
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of Dasatinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
  • History of or current autoimmune disease.
  • Systemic cancer chemotherapy within 2 weeks prior to study.
  • Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation.
  • Active malignancy other than ALL with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix.
  • Active infection, any other concurrent disease or medical conditions that are deemed to interfere with the conduct of the study as judged by the investigator.
  • Nursing women or women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception during participation in the study and at least three months thereafter.
Contacts and Locations
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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): NCT02744768


Contacts
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Contact: Paola Fazi +39 06.70390521 p.fazi@gimema.it
Contact: Enrico Crea +39 0670390514 e.crea@gimema.it

Locations
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Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
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Study Chair: Roberto Foà Policlinico Umberto I, Hematology Department.
  Study Documents (Full-Text)

Documents provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Statistical Analysis Plan  [PDF] December 9, 2016
Study Protocol  [PDF] November 9, 2016

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT02744768    
Other Study ID Numbers: LAL2116
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Dasatinib
Blinatumomab
Tyrosine Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents