Inotuzumab Ozogamicin and Conventional Chemotherapy In Patients Aged 56 Years and Older With ALL
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|ClinicalTrials.gov Identifier: NCT03460522|
Recruitment Status : Active, not recruiting
First Posted : March 9, 2018
Last Update Posted : May 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Precursor Cell Lymphoblastic Leukemia||Drug: Inotuzumab ozogamicin||Phase 2|
Despite recent advances especially in younger patients, the prognosis of elderly patients with ALL remains dismal with a 5-year survival rate of around 20%, even after intensive chemotherapy.
Inotuzumab ozogamicin (PF-05208773; CMC-544) is an antibody-targeted intravenous (IV) chemotherapy agent composed of an anti-CD22 antibody linked to calicheamicin, a potent cytotoxic antitumor antibiotic.
After a prephase treatment, induction therapy will be based on inotuzumab ozogamicin and intrathecal therapy only. After a maximum of three cycles, patients will receive an age adapted intermediate dose consolidation chemotherapy based on the backbone of the German Multicenter Study Group for adult ALL (GMALL). This will be followed by a conventional maintenance therapy. All patients will be followed for cytological response, minimal residual disease and safety parameters.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label Phase II Study to Evaluate the Efficacy and Safety of Inotuzumab Ozogamicin for Induction Followed by Chemotherapy Consolidation and Maintenance Therapy In Patients Aged 56 Years and Older With Acute Lymphoblastic Leukemia (ALL)|
|Actual Study Start Date :||May 2, 2018|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||April 2023|
Experimental: Induction Therapy with Inotuzumab Ozogamicin
Patients will receive up to 3 cycles Inotuzumab with applications on day 1, 8 and 15 in each cycle. First dose will be 0.8 mg/m² on Day 1. All subsequent doses will be 0,5 mg/m².
Drug: Inotuzumab ozogamicin
Patients will receive standard of care chemotherapy (consolidation and maintenance) after Inotuzumab Ozogamicin.
- Event free survival (EFS) at 12-months follow-up [ Time Frame: At 12 months ]An event is any of the following: persisting bone marrow blasts (more than 5% leukemic blasts) after two cycles of inotuzumab ozogamicin, relapse or death.
- Complete hematological remission [ Time Frame: 42 days ]The rate of complete hematological remission after inotuzumab ozogamicin induction treatment
- MRD response after induction treatment [ Time Frame: 42 days ]The rate of patients being negative for minimal residual disease (defined by RQ-PCR for at least one leukemia-specific IG/TR gene rearrangement or leukemia specific genetic aberration with a sensitivity of at least 10-4) after induction treatment
- Relapse free survival [ Time Frame: two years ]Relapse free survival after two years
- Molecular relapse [ Time Frame: two years ]The proportion of patients with molecular relapse
- Overall survival [ Time Frame: two years ]Overall survival after two years
- Death during induction [ Time Frame: 42 days ]Death during induction
- Death in complete remission [ Time Frame: up to 2 years ]Death in complete remission
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): NCT03460522
|Klinikum Chemnitz gGmbH|
|University Hospital Düsseldorf|
|Düsseldorf, Germany, 40225|
|University Hospital of Frankfurt|
|Frankfurt, Germany, 60590|
|Heidelberg, Germany, 69120|
|University of Muenster|
|Münster, Germany, 48149|
|Klinikum Nürnberg Nord|
|Robert - Bosch - Krankenhaus|
|Principal Investigator:||Matthias Stelljes, MD||University of Münster|