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Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia

Complete title: An Open-Label, Phase 2 Study Of Inotuzumab Ozogamicin In Subjects With Relapsed Or Refractory Cd22-Positive Acute Lymphocytic Leukemia

Research Study Number       20111581
    
Principal Investigator       Andrei Shustov, MD
    
Phase       II

Look up trial at NIH

Research Study Description

The purpose of this study is to assess the safety, tolerability and efficacy at increasing dose levels of inotuzumab ozogamicin in subjects with CD22-positive relapsed or refractory adult acute lymphocytic leukemia (ALL) in order to select the recommended phase 2 dose (RP2D) and schedule.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

- Subjects with CD22-positive ALL with either refractory disease (i.e. disease progression or no response while receiving their most recent prior anti-cancer therapy), or relapsed disease (i.e. response to their most recent prior anti-cancer therapy with subsequent relapse).

- Subjects with Philadelphia chromosome-positive (Ph+) ALL must have failed standard treatment with at least one tyrosine kinase inhibitor.

- Adequate renal and hepatic function, and negative pregnancy test for women of childbearing potential.

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- Subjects with isolated extramedullary relapse or active central nervous system (CNS) leukemia.

- Prior allogeneic hematopoietic stem cell transplant (HSCT) or other anti-CD22 immunotherapy within 4 months, or active graft versus host disease (GvHD) at study entry.

- Evidence or history of veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS).

Other exclusion criteria may apply.



Research Study Number       20111581
    
Contact       Seattle Cancer Care Alliance Intake Office
    
Telephone       800-804-8824 / 206-288-1024
    
    

Keywords
Acute Lymphoid Leukemia (ALL); Chronic Lymphoid Leukemia (CLL); Hematologic Malignancies; Leukemia

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