NCT06861348: ZJU-HSCT-INO

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

Not yet recruiting Phase 2 Last updated 6 March 2025

What this trial tests

Phase 2 trial testing Inotuzumab Ozogamicin±Donor Lymphocyte Infusion in Leukemia, Lymphocytic, Acute in 23 participants. Not yet recruiting.

Timeline

1 March 2025

Primary endpoint
30 April 2026

30 April 2027

Quick facts

Lead sponsor	First Affiliated Hospital of Zhejiang University
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	1 March 2025
Primary completion	30 April 2026
Estimated completion	30 April 2027
Sites	1 location across China

Drugs / interventions tested

• Inotuzumab Ozogamicin±Donor Lymphocyte Infusion — full drug profile →

Conditions studied

• Leukemia, Lymphocytic, Acute — all drugs for Leukemia, Lymphocytic, Acute →

Sponsor

First Affiliated Hospital of Zhejiang University

Who can join

Adults 14 to 65, any sex, with Leukemia, Lymphocytic, Acute. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.