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New hope for chinese adults with Hard-to-Treat leukemia

NCT ID NCT05687032

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called inotuzumab ozogamicin in 44 Chinese adults whose acute lymphoblastic leukemia (ALL) had come back or stopped responding to treatment. The drug targets a protein called CD22 on leukemia cells to destroy them. The main goal was to see how many patients achieved complete remission, meaning no signs of cancer in the bone marrow or blood.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

44 people

The number who actually took part.

Started

Feb 2023

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia B-cell acute lymphoblastic leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute lymphoblastic leukemia

Contacts and locations

Locations

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350000, China

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008, China

  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300020, China

  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

    Tianjin, 301600, China

  • NanFang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515, China

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510700, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006, China

  • The First Affiliated Hospital of Wenzhou Medical College

    Wenzhou, Zhejiang, 325000, China

  • The First Hospital of Harbin

    Harbin, Heilongjiang, 150010, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The first Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology

    Wuhan, Hubei, 430030, China

  • Union Hospital, Tongji Medical College of Huazhong University of Science & Technology

    Wuhan, Hubei, 430022, China

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041, China

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