Dose-dense mini-CVD plus inotuzumab ozogamicin, blinatumomab demonstrates deep, durable responses in relapsed or refractory B-ALL

Dose-dense mini-CVD in combination with inotuzumab and blinatumomab leads to early and high overall rates of deep MRD negativity by NGS of 95% (44% post C1) with a 3-year OS rate of 80% approximately. These deep NGS MRD-negative responses allow for consolidation with CAR T-cell therapy leading to a 3-year OS rate of close to 90% with a cumulative incidence of relapse rate of 11%. Further evaluation of this regimen is ongoing in the frontline setting. — Elias Jabbour, MD

The three-year analysis from a phase 2 trial showed dose-dense mini-CVD (cyclophosphamide, vincristine, and dexamethasone) plus inotuzumab ozogamicin and blinatumomab achieved deep responses and high rates of event-free survival (EFS) and overall survival (OS) for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL).

The analysis, led by Hannah Goulart, MD, of The University of Texas MD Anderson Cancer Center in Houston Texas, was presented at the Fourteenth Annual Meeting of the Society of Hematologic Oncology in Houston, Texas.

The study enrolled 27 patients with a median age of 42 years (range, 19-62), including three with Philadelphia chromosome–positive B-ALL. After treatment with dose-dense mini-CVD plus inotuzumab ozogamicin and blinatumomab, 70% of patients achieved complete remission (CR), and the remainder achieved CR with incomplete hematologic recovery. Overall, 21 patients achieved negative measurable residual disease (MRD) on next-generation sequencing, including 44% after the first treatment cycle.

The median follow-up duration was 36 months, and median EFS and OS were not reached. The three-year EFS rate was 69% and the three-year OS rate was 79%. After dose-dense mini-CVD plus inotuzumab ozogamicin and blinatumomab, 11 patients received chimeric antigen receptor (CAR) T-cell therapy, five received autologous stem cell transplantation (SCT), and 11 received no consolidation therapy. Three-year EFS rates (P=.25) and OS rates (P=.19) for these subgroups were as follows.

Dose-dense mini-CVD plus inotuzumab ozogamicin and blinatumomab achieved a 100% response rate with a 95% MRD–negativity rate in patients with relapsed or refractory B-ALL, and subsequent CAR T-cell consolidation therapy provided an EFS rate above 80%, Dr. Goulart and colleagues summarized.

Reference
Goulart H, Kantarjian H, Jain N, et al. Three-year follow-up of dose-dense mini-CVD in combination with inotuzumab ozogamicin and blinatumomab for patients with relapsed/refractory B-cell acute lymphoblastic leukemia. Abstract ALL-866. Presented at the 2026 Society of Hematologic Oncology Annual Meeting; September 9-12, 2026; Houston. 

Read more from SOHO 2026 here.