NCT06861348Not yet recruitingPhase 2

Effectiveness and Safety of InO±DLI for Relapsed B-ALL/LBL After Allo-HSCT

Effectiveness and Safety of Inotuzumab Ozogamicin±Donor Lymphocyte Infusion for Relapsed B Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma After Allogeneic Hematopoietic Stem Cell Transplantation：Phrase II, Multicenter Study

Source: ClinicalTrials.gov · Last updated 6 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

B cell acute lymphoblastic leukemia (B-ALL)/Lymphoblastic lymphoma (LBL) is a hematological malignancy caused by malignant transformation and clonal expansion of B-lineage precursor cells. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains a potential curable therapy for ALL, especially for high-risk ALL patients. However, post-HSCT recurrence is the primary cause of transplant failure and salvage treatment option for this patient population are very limited. Current data showed that the CR rate and overall survival (OS) in adults with ALL who relapse after transplantation are as low as 30% and 25%, respectively, and the prognosis is extremely dismal. Some researchers have successfully salvage treated relapsed B-ALL patients after transplantation with donor lymphocyte infusions (DLI), but the response rate of DLI alone is usually less than 10%, with increased risk of Graft-Versus-Host Disease (GvHD). In the immunotherapy era, the introduction of immuno-designed therapies like bispecific antibody constructs, antibody conjugates, as well as chimeric antigen receptor T cell (CAR-T) therapy, have immensely broadened the treatment landscape of relapsed or refractory (r/r) B-ALL. Inotuzumab ozogamicin (InO) is a CD22-targeted monoclonal antibody conjugated to the cytotoxic antibiotic calicheamicin. Based on the pivotal Phase III INO-VATE clinical trial published in N Engl J Med in 2016, compared to standard chemotherapy, 73% (64/88) of r/r B-ALL patients treated with InO achieved CR/CRi in the first cycle. Superior CR duration, OS and relapse free survival (RFS) was also observed in the InO group. Subgroup analysis showed that the treatment benefits were consistent for patients who relapsed after allo-HSCT. Moreover, a single-center retrospective study attempted to salvage treat relapsed B-ALL patients after transplantation with combined InO and DLI, results showed that six out of eight patients achieved CR after the first InO course and 75% of patients obtained MRD negativity after the second course, which is quite satisfactory. Therefore, we designed a Phase II clinical study of InO combined with or without DLI in patients with recurrent acute B-ALL/LBL after allo-HSCT, with expectation to increase CR rate and improve long-term survival.

Status (registry): Not yet recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 23 (estimated)
First submitted: 3 Mar 2025
Start date: 1 Mar 2025
Primary completion date: 30 Apr 2026
Lead sponsor: First Affiliated Hospital of Zhejiang University
Diseases: Acute lymphoblastic leukaemia, Childhood cancers
NCT number: NCT06861348

What you commit to

Study type: Interventional · Phase 2
Planned participants: 23
From 1 Mar 2025 to the primary completion date, 30 Apr 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Drug abuse or chronic alcohol abuse that may affect the study results;

Other illness

Allergic or with a history of serious adverse reactions to drugs or drugs with similar chemical structure in this study;
Severe pulmonary disorders (obstructive or restrictive ventilation disorder);
Participants with active infection or active bleeding who were deemed intolerance to InO treatment by the investigators;
A history of new thrombosis, embolism, cerebral hemorrhage or other diseases within one year before enrollment;
Participants suffer from known or other mental disorders that investigators are unable to obtain informed consent and may interfere with their ability to comply with research requirements;
A history of major organ surgery within the past six weeks;
Participants with a history of organ transplantation other than HSCT (except BMT);

Lab values

Severe cardiac dysfunction: left ventricular ejection fraction (LVEF) \<60%; Or severe arrhythmia: a history of a clinically significant corrected interval (QTc) prolongation (male \>450ms; female\>470 ms), ventricular tachycardia, atrial fibrillation, second degree atrioventricular block; myocardial infarction and coronary heart disease with clinical symptoms requiring medical treatment within one year before enrollment;
Severe liver function impairment: ALT, AST, or TBIL is more than 3 times higher than the upper limit of normal value (ULN);
Severe renal impairment: serum Cr is more than 2 times higher than the upper limit of normal (ULN); Or 24-hour urinary creatinine clearance \<50ml/min;

Other

Women who are pregnant or breastfeeding, as well as those who are unwilling to take effective contraceptive measures;
Other situations identified by the investigator as unsuitable to participate in the study.

Who the study is looking for

Aged 14-65 years, male or female;
Participants with CD22 positive B-ALL/LBL who relapsed after allo-HSCT from a related or unrelated donor (regardless of CD22 expression);
ECOG physical status score 0\~3, Karnofsky score ≥70;
No active grade III/IV graft-versus-host disease (GvHD) or any active liver GvHD, no history of venous occlusive disease (VOD); No active GvHD and no previous history of VOD;
Creatinine clearance rate≥50 mL/min (estimate by Cockcroft-Gault Equation);
Liver function: alanine transaminase (ALT) and aspartate aminotransferase (AST)≤ 3×upper limit of normal (ULN), and total bilirubin ≤ 2×ULN;
Left ventricular ejection fraction (LVEF) ≥50% as measured by echocardiography;
Estimated life expectancy \>3 months;
Participants voluntarily participate in clinical trial; Understand and know this study, sign an informed consent form, and be willing to follow all experimental procedures.

Age in the registry: 14 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
The First Affiliated Hospital, College of Medicine, Zhejiang University Coordinator of this site? Confirm its status	Hangzhou	China	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.