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A Study of Inotuzumab Ozogamicin in Chinese Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

CompletedPhase 4

Sponsor: Pfizer

Conditions: Acute Lymphoblastic Leukemia

Interventions: inotuzumab ozogamicin

Countries: China

This is an open-label, single-arm, multicenter study in Chinese patients with relapsed or refractory CD22-positive B-cell ALL. The objective of the study is to confirm the efficacy, safety, and PK of inotuzumab ozogamicin in patients with relapsed or refractory B-cell ALL from mainland China.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Male or female participants, age 18 years or older at screening.
* Relapsed or refractory CD22-positive ALL.
* Subjects with Philadelphia chromosome-positive (Ph+) ALL must have failed standard treatment with at least one tyrosine kinase inhibitor.
* Patients in Salvage 1 with late relapse should be deemed poor candidates for reinduction with initial therapy.
* Patients with lymphoblastic lymphoma and bone marrow involvement ≥5% lymphoblasts by morphologic assessment.
* ECOG performance status 0-2.
* Adequate renal and hepatic function, and negative pregnancy test for women of childbearing potential.

Exclusion Criteria:

* 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).

Locations (16)

Beijing, Beijing Municipality, China
Fuzhou, Fujian, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Harbin, Heilongjiang, China
Zhengzhou, Henan, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Suzhou, Jiangsu, China
Changchun, Jilin, China
Chengdu, Sichuan, China
Tianjin, Tianjin Municipality, China
Hangzhou, Zhejiang, China
Wenzhou, Zhejiang, China
Tianjin, China