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

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · May 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Inotuzumab Ozogamicin to see if it can help prevent relapse in patients with a type of blood cancer known as acute lymphoblastic leukemia (ALL) after they have undergone a stem cell transplant. The trial is specifically looking at patients who are at high risk for relapse after the transplant. Researchers want to find out if giving a low dose of this medication can keep the leukemia from coming back and help patients live longer without the disease.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with a specific type of ALL that tests positive for a marker called CD22. They should have had a stem cell transplant and be at least 60 days post-transplant, showing that their body has accepted the donor cells. Patients who have already shown signs of disease progression or have serious health issues that would make it hard for them to participate are not eligible. If you join the trial, you can expect to receive close monitoring by healthcare professionals to ensure your safety and to track how well the treatment is working. This trial is currently recruiting participants, and it offers a chance to contribute to important research that could improve treatment options for others in the future.

Gender

ALL

Eligibility criteria

• 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