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Sequential Chemotherapy and Blinatumomab to Improve MRD Response and Survival in Acute Lymphoblastic Leukemia (LAL2317)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03367299
Recruitment Status : Recruiting
First Posted : December 8, 2017
Last Update Posted : April 13, 2020
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief Summary:
The present study aims at analyzing the response to treatment of adult patients homogeneously treated with supportive care, chemotherapy and blinatumomab.

Condition or disease Intervention/treatment Phase
Acute Lymphoid Leukemia Philadelphia Chromosome-Negative B-Cell Precursor Drug: Chemotherapy + Blinatumomab Phase 2

Detailed Description:
Eligible patients with CD19+ Ph- BCP ALL (Philadelphia-negative B-cell precursor acute lymphoblastic leukemia) will receive homogeneous supportive care, chemotherapy and blinatumomab immunotherapy, and will be homogeneously analyzed for response at prefixed time points from induction day 1. For risk-oriented therapy, patients in complete remission (CR) will be stratified by risk class according to the diagnostic characteristics and MRD (minimal residual disease) study results during early consolidation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 149 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: National Treatment Program With Sequential Chemotherapy and Blinatumomab to Improve Minimal Residual Disease Response and Survival in Philadelphia Chromosome-Negative B-Cell Precursor Adult Acute Lymphoblastic Leukemia
Actual Study Start Date : August 22, 2018
Estimated Primary Completion Date : August 22, 2023
Estimated Study Completion Date : August 22, 2023

Arm Intervention/treatment
Experimental: Chemotherapy + Blinatumomab
Treatment sequence consists of eight chemotherapy courses and two blinatumomab courses. Patients not in CR after chemotherapy course 2 will go off-study.
Drug: Chemotherapy + Blinatumomab
Chemotherapy cycles are administered at 21-28 days intervals and each blinatumomab course is 28-day long.

Primary Outcome Measures :
  1. Number of patients that obtain a negative Minimal Residual Disease (MRD) [ Time Frame: At week 14 from study entry ]

Secondary Outcome Measures :
  1. Number of patients in complete remission (CR) [ Time Frame: At 32 months from study entry ]
  2. Number of patients that reach disease-free survial [ Time Frame: At 32 months from study entry ]
  3. Number of patients that relapse [ Time Frame: At 32 months from study entry ]
  4. Number of patients that dye due to treatment [ Time Frame: At 32 months from study entry ]
    Treatment-related mortality

  5. Number of serious adverse events [ Time Frame: At 32 months from study entry ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed written informed consent according to ICH/EU/GCP and national local laws.
  • Age 18-65 years.
  • A diagnosis of untreated Ph- CD19+ BCP ALL is required, either de novo or secondary to chemo-radiotherapy for another cancer. Pre-treatment with low-dose corticosteroids in patients presenting with hyperleukocytosis is allowed. Before enrolment and pre-phase is allowed only in patients presenting with severe, potentially life-threatening disease-related clinical symptoms. All diagnostic procedures need to be performed on freshly obtained bone marrow (BM) and peripheral blood (PB) samples.
  • Full cytological, cytochemical, immunophenotypic, cytogenetic and molecular disease characterization according to the EGIL and WHO classifications.
  • BM and PB sampling for MRD evaluations study. Detailed indications on patient registration, storage of representative diagnostic material and diagnostic work-up, including the shipping of samples for the diagnostic work-up and MRD follow-up studies are given in Appendix A.
  • An ECOG performance status 0-2, unless a performance of 3 is unequivocally caused by the disease itself, (and not by pre-existing comorbidities,) and is considered and/or documented to be reversible following the application of anti-leukemic therapy and appropriate supportive measures.

Exclusion Criteria:

  • Diagnosis of Burkitt's leukemia/lymphoma, CD19- BCP ALL, Ph+ ALL, T-ALL, lymphoblastic lymphoma (BM involvement by blast cells <25%).
  • Active CNS leukemia documented by diagnostic lumbar puncture on days -1 to -5 prior to the first blinatumomab administration, or any other clinical sign or symptom ascribable to symptomatic/documented CNS disease at time of each planned blinatumomab course.
  • Down's syndrome.
  • A pre-existing, uncontrolled pathology such as heart failure (congestive/ischemic, acute myocardial infarction within the past 3 months, untreatable arrhythmias, NYHA classes III and IV), severe liver disease with serum bilirubin >3 mg/dL and/or ALT >3 x upper normal limit (unless attributable to ALL), kidney function impairment with serum creatinine >2 mg/dL (unless attributable to ALL), and severe neuropsychiatric disorder that impairs the patient's ability to understand and sign the informed consent, or to cope with the intended treatment plan. N.B. For altered liver and kidney function tests, eligibility criteria can be reassessed at 24-96 hours, following the institution of adequate supportive measures.
  • Presence of serious, active, uncontrolled infections.
  • Pre-existing HIV positive serology (i.e. already known before enrolment). If HIV positivity is detected after enrolment, the patient is put off study.
  • A history of cancer that is not in a remission phase following surgery and/or radiotherapy and/or chemotherapy, with a life expectancy <1 year.
  • Pregnancy declared by the patient, unless a decision is taken with the patient to induce a therapeutic abortion in order to carry on with the ALL therapy. A pregnancy test is performed at diagnosis, but does not preclude the enrolment into study. Fertile patients will be advised to adopt contraceptive methods while on treatment.

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 identifier (NCT number): NCT03367299

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Contact: Paola Fazi +39 0670390514
Contact: Enrico Crea +39 0670390514

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Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
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Study Chair: Renato Bassan Azienda ULSS 12 "Veneziana" U.O. Ematologia Direttore Renato Bassan
Study Director: Roberto Foà Policlinico Umberto I, Hematology Department.
Study Director: Alessandro Rambaldi Ospedale di Bergamo
Additional Information:
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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto Identifier: NCT03367299    
Other Study ID Numbers: LAL2317
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Acute Lymphoid Leukemia
Philadelphia Chromosome-Negative B-Cell Precursor
Minimal residual disease
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Philadelphia Chromosome
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Antineoplastic Agents