Phase II Study of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of Acute Lymphoblastic Leukemia

NCT06427330 | Recruiting Phase 2

• 1 other identifier: IIT2024022
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

To learn about the safety of post-HSCT two dose Inotuzumab Ozogamicin to participants with high risk B cell acute lymphoblastic leukemia(B-ALL). Also, to learn if giving Inotuzumab Ozogamicin to post-HSCT patients with high-risk B- ALL can help to reduce relapse and prolong disease free survival and overall survival.

Conditions

Acute Lymphoid Leukemia

Outcome Measures

Primary Outcomes (1)

• DFS

  Efficacy as measured by DFS at one year, estimated using Kaplan-Meier, reported as median and 2-sided 80% and 95% Confidence Interval (CI) DFS is defined as "Time from date of HSCT to the date of disease progression (ie,objective progression, relapse from CR/CRi), or death due to any cause, whichever occurs first (including post-study treatment follow-up disease assessments)".

  at one year after HSCT

Secondary Outcomes (6)

• Overall survival

  at one year after HSCT

• Relapse

  at one year after HSCT

• NRM

  at one year after HSCT

• Incidence of hematological toxicity

  at one year after HSCT

• Incidence of secondary graft failure(GF)

  at one year after HSCT

Study Arms (1)

Inotuzumab ozogamicin

EXPERIMENTAL

Drug: Inotuzumab ozogamicin

Interventions

Inotuzumab ozogamicin DRUG

1. st dose is given after D+60：inotuzumab 0.3mg/m2 2. nd dose is given after 1 month：inotuzumab 0.6mg/m2

Inotuzumab ozogamicin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of CD22-positive Acute Lymphoblastic Leukemia
• Patients who underwent an allogeneic hematopoietic stem cell transplantation(HSCT) from any donor source or auto-HSCT for acute lymphocytic leukemia
• Patients who are after T+60 after transplantation
• Patients who have/are either:
• High risk B-ALL: (1) high white blood cell(WBC) count when newly diagnosed, (2) Poor risk group according to NCCN guideline 2021 of Acute Lymphoblastic
• Leukemia
• Relapsed or refractory to at least 1 line of treatment
• Minimal residual disease(MRD) positive before HSCT, including flow cytometry and cytogenetic test
• Patients who have \> 99% donor chimerism after allogeneic transplantation.
• Eastern Cooperative Oncology Group(ECOG) Performance status ≤ 2
• Participants must have ANC \> 1,000/µL for 3 days and platelet transfusion independence as defined as a platelet count \> 50,000/µL for 7 days.
• ≥ 18 years old, including male and female
• Participants must have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Patients with evidence of disease progression prior to enrollment
• Persistent prior treatment toxicities Grade 2 and above according to NCI CTCAE Version 4.03 (with the exception for alopecia, neuropathy, etc.)
• Patients with inadequate organ function and can't tolerate the study treatment determined by investigator as defined by:
• Severe renal deficiency, with creatinine clearance \< 50ml/min
• Severe hepatic deficiency
• Bilirubin, aspartate aminotransferase(AST), and/or ALT(ALT) \> 2X institutional upper limit of normal
• Severe cardiac or pulmonary deficiency
• Graft-versus-host disease(GVHD) grade III or IV (for patients with a prior allogeneic transplant).
• Active acute or chronic GVHD of the liver (for patients with a prior allogeneic transplant)
• History of veno-occlusive disease(VOD)
• Second active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast)
• Patients with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)
• Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
• Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Inotuzumab Ozogamicin

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Calicheamicins; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 23, 2024
• Study Start: July 2, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 30, 2024

Record last verified: 2024-04

Locations

CN (1)