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Study of Inotuzumab Ozogamicin Combined to Chemotherapy in Older Patients With Philadelphia Chromosome-negative CD22+ B-cell Precursor ALL (EWALL-INO)

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ClinicalTrials.gov Identifier: NCT03249870
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Patrice Chevallier, Nantes University Hospital

Brief Summary:
The aim of the present EWALL-INO study is to confirm very promising results obtained with a combination of INO and mild chemotherapy in older de novo CD22+ B-ALL patients. For that purpose, safety and efficacy of a weekly INO administration combined to mild-intensity chemotherapy will be evaluated in a cohort of patients aged more than 55 years with newly diagnosed previously untreated Ph-negative (CD22+) BCP-ALL. Conversely to the MDACC miniHCVD-INO study and in order to lower the overall toxicity of the combination, INO will be given as part of the remission induction treatment phase during the first 2 treatment cycles only, in combination with corticosteroid, vincristine, cyclophosphamide and intrathecal prophylaxis only; then, all responding patients will received standard INO-free chemotherapy as consolidation and maintenance.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia (ALL) - Philadelphia Chromosome (Ph)-Negative CD22+ B-cell Precursor (BCP) Drug: Inotuzumab ozogamicin (INO) Phase 2

Detailed Description:

INO schedule of administration will be as described in the refractory/relapsed INO-VATE study for the first cycle, with sequential day 1/8/15 doses of 0.8, 0.5 and 0.5 mg/m2, respectively. Reduced dose of INO will be used for the second and last cycle (0.5 mg/m2 on day 1/8). This was retained in order:

  1. to minimize potential toxicities, including liver disorders and prolonged thrombocytopenia; and
  2. to allow delivery of subsequent chemotherapy consolidations cycles.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Inotuzumab Ozogamicin (INO) Combined to Chemotherapy in Older Patients With Philadelphia Chromosome-negative CD22+ B-cell Precursor Acute Lymphoblastic Leukemia
Actual Study Start Date : December 28, 2017
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021


Arm Intervention/treatment
Experimental: Inotuzumab ozogamicin (INO) Drug: Inotuzumab ozogamicin (INO)

INO schedule of administration is as follows:

  • First induction course: 0.8 mg/m² on day 1, 0.5 mg/m² on day 8, and 0.5 mg/m² on day 15
  • Second induction course: 0.5 mg/m² on day 1, and 0.5 mg/m² on day 8




Primary Outcome Measures :
  1. Assessment of overall survival (OS) [ Time Frame: one year ]
    The primary objective of the trial is to assess overall survival (OS) observed at 1 year after administration of INO and chemotherapy in older Ph-negative BCP-ALL patients.


Secondary Outcome Measures :
  1. Assessment of adverse events (AEs) [ Time Frame: 3 months ]
    Type, duration and frequency of AEs up to 3 months of induction course 1 or 2

  2. Rate of complete remission (CR / CRp) [ Time Frame: 35 days ]
    CR/CRp response rate after INO-based induction course 1 and 2

  3. Assessment of Minimal residual disease (MRD) [ Time Frame: 35 days ]
    Flow cytometry and Ig-TCR MRD levels, after INO-based induction course 1 and 2 and impact on outcomes

  4. Rate of early death [ Time Frame: 100 days ]
    Early death (ED) rate at 30, 60 and 100 day from treatment initiation

  5. Composite measure for Duration of response (DOR), Disease-free survival (DFS) and cumulative incidence of relapse (CIR) [ Time Frame: one year ]
    Duration of response (DOR), Disease-free survival (DFS) and cumulative incidence of relapse (CIR)



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged more than 55 years old,
  • With confirmed diagnosis of BCP-ALL according to World Health Organisation (WHO) criteria expressing the CD22 antigen by flow cytometry (20% or more positive blast cells),
  • Without central nervous system (CNS) involvement,
  • Without BCR-ABL fusion by standard cytogenetics, Fluorescence In Situ Hybridization (FISH) analysis and/or RT-PCR,
  • Previously untreated,
  • Eligible to intensive chemotherapy, due to general health status,
  • ECOG performance status ≤ 2,
  • Patients must have the following laboratory values unless considered due to leukemia: AST and ALT ≤ 2.5 x upper the limit of normal (ULN); estimated GFR ≥ 50 mL/min using the MDRD equation; total and direct serum bilirubin ≤ 1.5 x ULN; electrolyte panel within normal ranges for the institution unless attributed to the underlying disease.
  • Written informed consent obtained prior to any screening procedures.
  • Eligible for National Health Insurance in France.

Exclusion Criteria:

  • Concurrent therapy with any other investigational agent or cytotoxic drug,
  • Prior documented chronic liver disease,
  • Active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) or positive HIV serology,
  • Female patients who are pregnant or breast feeding or patients of childbearing potential not willing to use a double barrier method of contraception during the study and for 3 months following the last dose of maintenance.
  • Male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a double barrier method of contraception, one of which includes a condom, during the study and for 3 months following the last dose of maintenance.
  • Any of concurrent severe and/or uncontrolled medical condition, which could compromise participation in the study.

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): NCT03249870


Contacts
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Contact: Assitan KONE +33 1 39 23 97 75 akone@ch-versailles.fr
Contact: Laure MORISSET +33 1 39 23 97 85 lmorisset@ch-versailles.fr

Locations
Show Show 35 study locations
Sponsors and Collaborators
Versailles Hospital
Investigators
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Principal Investigator: Patrice CHEVALLIER, MD Nantes University Hospital
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Responsible Party: Patrice Chevallier, MD, PhD, Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03249870    
Other Study ID Numbers: P16/11- EWALL INO
2016-004942-27 ( EudraCT Number )
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 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
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
Inotuzumab Ozogamicin
Antineoplastic Agents