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

Pfizer

Status and phase

Completed

Phase 4

Conditions

Acute Lymphoblastic Leukemia

Treatments

Drug: inotuzumab ozogamicin

Study type

Interventional

Funder types

Industry

Identifiers

NCT05687032

NCT05687032 (Registry Identifier)

B1931034

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).