search
Back to results

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

Primary Purpose

Acute Lymphoblastic Leukemia

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
inotuzumab ozogamicin
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Peking University First HospitalRecruiting
  • Peking University Third HospitalRecruiting
  • Fujian Medical University Union HospitalRecruiting
  • Guangzhou First People's HospitalRecruiting
  • NanFang Hospital of Southern Medical UniversityRecruiting
  • SUN Yat-Sen University Cancer CenterRecruiting
  • The First Hospital of HarbinRecruiting
  • Henan Cancer HospitalRecruiting
  • Union Hospital, Tongji Medical College of Huazhong University of Science & TechnologyRecruiting
  • Tongji Hospital, Tongji Medical College,Huazhong University of Science and TechnologyRecruiting
  • Wuhan Tongji Hospital
  • Nanjing Drum Tower HospitalRecruiting
  • The First Affiliated Hospital of Soochow UniversityRecruiting
  • The First Hospital of Jilin UniversityRecruiting
  • West China Hospital of Sichuan UniversityRecruiting
  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical SciencesRecruiting
  • Tianjin Medical University General Hospital
  • Tianjin Medical University General HospitalRecruiting
  • The first Affiliated Hospital, Zhejiang University School of MedicineRecruiting
  • The First Affiliated Hospital of Wenzhou Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

inotuzumab ozogamicin

Arm Description

Dose: inotuzumab ozogamicin 0.8-0.5 mg/m^2 IV, weekly, 3 times per cycle Cycle length: 21-28 days Total number of cycles: 6

Outcomes

Primary Outcome Measures

Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) per Investigator Assessment
CR was the disappearance of leukemia indicated by less than (<) 5 percent (%) marrow blasts & absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) greater than or equal to (≥)1000 per microliter (/μL) & platelets ≥100,000/μL. C1 extramedullary disease status (i.e. complete disappearance of measurable & non-measurable extramedullary disease with the following exceptions: for participants with at least 1 measurable lesion, all nodal masses greater than (>) 1.5 centimeters (cm) in greatest transverse diameter (GTD) at baseline must have regressed to less than or equal to (≤) 1.5 cm in GTD; all nodal masses ≥1 cm & ≤1.5 cm in GTD at baseline must have regressed to <1 cm GTD or reduced by 75% in sum of products of greatest diameters, no new lesions, spleen & other previously enlarged organs must have regressed in size & must not be palpable) was required. CRi was defined as CR except ANC <1000/μL &/or platelets <100,000/μL.

Secondary Outcome Measures

Duration of Remission (DoR) for Participants Who Achieved CR/CRi
DoR was defined as time from date of first response in responders (CR/CRi per Investigator assessment) to date of PFS event (i.e., death, progressive disease [objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status] or starting new induction therapy or post-therapy stem cell transplant [SCT] without achieving CR/CRi). Participants without a DoR event at a time of analysis will be censored at the date of last valid disease assessment including follow-up disease assessment。
Percentage of Participants Achieving MRD Negativity (Based on Central Laboratory Analysis) in Participants Achieving a CR/CRi
Bone marrow aspirate, collected at screening and for remission status and assessment of MRD. MRD will be assessed using NGS for rearranged IgH, IgK, and IgL receptor gene sequences at a central laboratory. MRD analysis will be done at least once in patients with prior assessment of CR or CRi. MRD-negativity will be defined as malignant B lymphocytes occurring at a frequency of <10^-4.
Progression-Free Survival (PFS)
PFS was defined as time from date of randomization to earliest date of the following events: death, progressive disease (objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status) and starting new induction therapy or post-therapy SCT without achieving CR/CRi. Participants without a PFS event at time of analysis were censored at the last valid disease assessment. In addition, participants with documentation of an event after an unacceptably long interval (>28 weeks if there was post-baseline disease assessment, or >12 weeks if there was no post-baseline assessment) since the previous disease assessment were censored at the time of the previous assessment (date of randomization if no post-baseline assessment). Post-study treatment follow-up disease assessments was included. Kaplan-Meier method used and 2-sided 95% confidence interval (CI) calculated based on the Brookmeyer and Crowley method.
Overall Survival (OS)
OS was defined as the time from first dose to date of death due to any cause. Participants last known to be alive were censored at date of last contact.
Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT)
HSCT rate is defined as the percentage of participants who proceed to HSCT among participants who take at least one dose of inotuzumab ozogamicin.
Percentage of Participants With Treatment-emergent Adverse Events
Type and severity (including severity per National Cancer Institutes [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 5.0), including Veno-Occlusive Liver Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) (total, during study treatment, and post-HSCT)
Percentage of Participants With Laboratory Abnormalities
Type and severity (including severity per National Cancer Institutes [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 5.0)
Maximum Observed Inotuzumab Ozogamicin Serum Concentration (Cmax) Following Single and Multiple Dosing
Cmax was the maximum observed concentration occurring between 0-8 hours post-dose.
Percentage of Participants With Anti-drug Antibodies (ADA)
Analysis will be performed by central laboratory.
Pre-Dose Inotuzumab Ozogamicin Serum Concentration (Ctrough) Following Single and Multiple Dosing
Ctrough was the concentration prior to subsequent dose (pre-dose) occurring after 8 hours.
Percentage of Participants With Neutralizing Antibodies (Nab).
Analysis will be performed by central laboratory.

Full Information

First Posted
January 6, 2023
Last Updated
September 13, 2023
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT05687032
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2023 (Actual)
Primary Completion Date
August 8, 2024 (Anticipated)
Study Completion Date
January 25, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
inotuzumab ozogamicin
Arm Type
Experimental
Arm Description
Dose: inotuzumab ozogamicin 0.8-0.5 mg/m^2 IV, weekly, 3 times per cycle Cycle length: 21-28 days Total number of cycles: 6
Intervention Type
Drug
Intervention Name(s)
inotuzumab ozogamicin
Other Intervention Name(s)
Besponsa
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) per Investigator Assessment
Description
CR was the disappearance of leukemia indicated by less than (<) 5 percent (%) marrow blasts & absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) greater than or equal to (≥)1000 per microliter (/μL) & platelets ≥100,000/μL. C1 extramedullary disease status (i.e. complete disappearance of measurable & non-measurable extramedullary disease with the following exceptions: for participants with at least 1 measurable lesion, all nodal masses greater than (>) 1.5 centimeters (cm) in greatest transverse diameter (GTD) at baseline must have regressed to less than or equal to (≤) 1.5 cm in GTD; all nodal masses ≥1 cm & ≤1.5 cm in GTD at baseline must have regressed to <1 cm GTD or reduced by 75% in sum of products of greatest diameters, no new lesions, spleen & other previously enlarged organs must have regressed in size & must not be palpable) was required. CRi was defined as CR except ANC <1000/μL &/or platelets <100,000/μL.
Time Frame
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 Outcome Measure Information:
Title
Duration of Remission (DoR) for Participants Who Achieved CR/CRi
Description
DoR was defined as time from date of first response in responders (CR/CRi per Investigator assessment) to date of PFS event (i.e., death, progressive disease [objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status] or starting new induction therapy or post-therapy stem cell transplant [SCT] without achieving CR/CRi). Participants without a DoR event at a time of analysis will be censored at the date of last valid disease assessment including follow-up disease assessment。
Time Frame
Up to approximately 2 years from first dose
Title
Percentage of Participants Achieving MRD Negativity (Based on Central Laboratory Analysis) in Participants Achieving a CR/CRi
Description
Bone marrow aspirate, collected at screening and for remission status and assessment of MRD. MRD will be assessed using NGS for rearranged IgH, IgK, and IgL receptor gene sequences at a central laboratory. MRD analysis will be done at least once in patients with prior assessment of CR or CRi. MRD-negativity will be defined as malignant B lymphocytes occurring at a frequency of <10^-4.
Time Frame
Up to approximately 4 weeks (EoT) from last dose of study drug
Title
Progression-Free Survival (PFS)
Description
PFS was defined as time from date of randomization to earliest date of the following events: death, progressive disease (objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status) and starting new induction therapy or post-therapy SCT without achieving CR/CRi. Participants without a PFS event at time of analysis were censored at the last valid disease assessment. In addition, participants with documentation of an event after an unacceptably long interval (>28 weeks if there was post-baseline disease assessment, or >12 weeks if there was no post-baseline assessment) since the previous disease assessment were censored at the time of the previous assessment (date of randomization if no post-baseline assessment). Post-study treatment follow-up disease assessments was included. Kaplan-Meier method used and 2-sided 95% confidence interval (CI) calculated based on the Brookmeyer and Crowley method.
Time Frame
Up to approximately 2 years from first dose
Title
Overall Survival (OS)
Description
OS was defined as the time from first dose to date of death due to any cause. Participants last known to be alive were censored at date of last contact.
Time Frame
Up to approximately 2 years from first dose
Title
Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT)
Description
HSCT rate is defined as the percentage of participants who proceed to HSCT among participants who take at least one dose of inotuzumab ozogamicin.
Time Frame
Up to approximately 2 years from first dose
Title
Percentage of Participants With Treatment-emergent Adverse Events
Description
Type and severity (including severity per National Cancer Institutes [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 5.0), including Veno-Occlusive Liver Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) (total, during study treatment, and post-HSCT)
Time Frame
Up to approximately 2 years from first dose
Title
Percentage of Participants With Laboratory Abnormalities
Description
Type and severity (including severity per National Cancer Institutes [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 5.0)
Time Frame
Up to approximately 2 years from first dose
Title
Maximum Observed Inotuzumab Ozogamicin Serum Concentration (Cmax) Following Single and Multiple Dosing
Description
Cmax was the maximum observed concentration occurring between 0-8 hours post-dose.
Time Frame
Days 1, 4, 8, and 15 of Cycle 1, Days 1 and 8 of Cycle 2 and Day 1 of Cycle 4
Title
Percentage of Participants With Anti-drug Antibodies (ADA)
Description
Analysis will be performed by central laboratory.
Time Frame
Day 1 of Cycle 1-6 and up to approximately 4 weeks (end of treatment [EoT]) from the last dose
Title
Pre-Dose Inotuzumab Ozogamicin Serum Concentration (Ctrough) Following Single and Multiple Dosing
Description
Ctrough was the concentration prior to subsequent dose (pre-dose) occurring after 8 hours.
Time Frame
Days 1, 4, 8, and 15 of Cycle 1, Days 1 and 8 of Cycle 2 and Day 1 of Cycle 4
Title
Percentage of Participants With Neutralizing Antibodies (Nab).
Description
Analysis will be performed by central laboratory.
Time Frame
Day 1 of Cycle 1-6 and up to approximately 4 weeks (end of treatment [EoT]) from the last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100091
Country
China
Individual Site Status
Recruiting
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
Individual Site Status
Recruiting
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Individual Site Status
Recruiting
Facility Name
NanFang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Name
SUN Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510700
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of Harbin
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150010
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Name
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
Wuhan Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Name
The first Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B1931034
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs