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Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
City of Hope National Medical Center
Duarte, California, 91010-3000 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Lymphocytic Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 enrolled in the Phase 2 portion of the
study must be due to receive salvage 2 or later therapy.

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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).

NCT01363297
Pfizer
Completed
Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia

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