Study of Inotuzumab Ozogamicin Combined to Chemotherapy in Older Patients With Philadelphia Chromosome-negative CD22+ B-cell Precursor ALL (EWALL-INO)
![]() |
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. |
ClinicalTrials.gov Identifier: NCT03249870 |
Recruitment Status :
Recruiting
First Posted : August 15, 2017
Last Update Posted : August 11, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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:
- to minimize potential toxicities, including liver disorders and prolonged thrombocytopenia; and
- to allow delivery of subsequent chemotherapy consolidations cycles.
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:
|
- 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.
- 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
- Rate of complete remission (CR / CRp) [ Time Frame: 35 days ]CR/CRp response rate after INO-based induction course 1 and 2
- 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
- Rate of early death [ Time Frame: 100 days ]Early death (ED) rate at 30, 60 and 100 day from treatment initiation
- 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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
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 |

Principal Investigator: | Patrice CHEVALLIER, MD | Nantes University Hospital |
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: | August 11, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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, Immunological Antineoplastic Agents Antibiotics, Antineoplastic |