Clinical trial NCT05687032: A Study of Inotuzumab Ozogamicin in Chinese Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Official title: A PHASE 4, OPEN-LABEL, SINGLE-ARM, MULTICENTER STUDY OF INOTUZUMAB OZOGAMICIN IN CHINESE ADULT PATIENTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Acute Lymphoblastic Leukemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-01-17
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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 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).

Primary outcomes:
measure: Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) per Investigator Assessment
timeFrame: Screening, Day 16 to 28 of Cycles 1, 2 and 3, then every 1 to 2 cycles (or as clinically indicated) up to approximately 4 weeks (end of treatment [EoT]) from the last dose
Secondary outcomes:
measure: Duration of Remission (DoR) for Participants Who Achieved CR/CRi
timeFrame: Up to approximately 2 years from first dose
measure: Percentage of Participants Achieving MRD Negativity (Based on Central Laboratory Analysis) in Participants Achieving a CR/CRi
timeFrame: Up to approximately 4 weeks (EoT) from last dose of study drug
measure: Progression-Free Survival (PFS)
timeFrame: Up to approximately 2 years from first dose
measure: Overall Survival (OS)
timeFrame: Up to approximately 2 years from first dose
measure: Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT)
timeFrame: Up to approximately 2 years from first dose
measure: Percentage of Participants With Treatment-emergent Adverse Events
timeFrame: Up to approximately 2 years from first dose
measure: Percentage of Participants With Laboratory Abnormalities
timeFrame: Up to approximately 2 years from first dose
measure: Maximum Observed Inotuzumab Ozogamicin Serum Concentration (Cmax) Following Single and Multiple Dosing
timeFrame: Days 1, 4, 8, and 15 of Cycle 1, Days 1 and 8 of Cycle 2 and Day 1 of Cycle 4
measure: Percentage of Participants With Anti-drug Antibodies (ADA)
timeFrame: Day 1 of Cycle 1-6 and up to approximately 4 weeks (end of treatment [EoT]) from the last dose
measure: Pre-Dose Inotuzumab Ozogamicin Serum Concentration (Ctrough) Following Single and Multiple Dosing
timeFrame: Days 1, 4, 8, and 15 of Cycle 1, Days 1 and 8 of Cycle 2 and Day 1 of Cycle 4
measure: Percentage of Participants With Neutralizing Antibodies (Nab).
timeFrame: Day 1 of Cycle 1-6 and up to approximately 4 weeks (end of treatment [EoT]) from the last dose
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: NanFang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Harbin
country: China
facility: The First Hospital of Harbin
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
state: Hubei
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
state: Tianjin
city: Hangzhou
country: China
facility: The first Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical College
state: Zhejiang
city: Tianjin
country: China
facility: Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: