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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|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
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)
- 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.
Acute Lymphoid Leukemia (ALL); Chronic Lymphoid Leukemia (CLL); Hematologic Malignancies; Leukemia
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