Acute Lymphoid Leukemia Clinical Trial
Official title:
Phase II Study Assessing the Efficacy and Safety of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of High Risk Acute Lymphoblastic Leukemia
Verified date | April 2024 |
Source | Institute of Hematology & Blood Diseases Hospital, China |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 21 |
Est. completion date | May 20, 2026 |
Est. primary completion date | May 20, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
China | Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Institute of Hematology & Blood Diseases Hospital, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Overall survival | Defined from time from HSCT to death due to any cause Defined from time from date of HSCT to death due to any cause, estimated using Kaplan-Meier, reported as median and 95% CI Difference in time-to-event endpoints will be tested using a 1-sided log-rank test at a significance level of 0.10 | at one year after HSCT | |
Secondary | Relapse | Defined as time from date of HSCT to the date of first relapse. Reported as Cumulative Incidence | at one year after HSCT | |
Secondary | NRM | Defined as time from date of first dose to death due to any cause without prior relapse. | at one year after HSCT | |
Secondary | Incidence of hematological toxicity | Number of patients who develop hematological toxicity while on study, defined as grade of anemia, neutropenia and thrombocytopenia, etc. | at one year after HSCT | |
Secondary | Incidence of secondary graft failure(GF) | Number of patients who develop secondary graft failure while on study, defined as: Either cytopenias after initial engraftment (ANC <500/µL), with (a) donor chimerism of less than 5% or (b) falling donor chimerism with intervention such as second transplant or donor lymphocyte infusion (DLI) or (c) patient death due to cytopenias, and fall in donor chimerism, even if chimerism was >5%. Exclusion criteria for diagnosis of GF were (a) disease relapse (b) graft versus host disease or (c) other causes of cytopenias such as, viral infections, or drug induced | at one year after HSCT | |
Secondary | Percent of participants with AE/SAEs | safety profile of intervention as measured by percent of participants with any grade AE/SAEs | at one year after HSCT |
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