Inotuzumab as Post-Trasplantation Therapy for Adult High-risk B-cell Precursor Acute Lymphoblastic Leukemia
Condition(s) studied
Investigational drug(s) / intervention(s)
Inotuzumab Ozogamicin (IO): Three doses of 0,5mg/m2 of Inotuzumab Ozogamicin will be given to participants at day +70 post-transplantation and a minimum interval of 30 days between consecutive administrations. All patients will receive treatment until treatment is completed, unacceptable toxicity, disease progression, patient withdrawal, loss of follow-up, end of study, study completion, or death, whichever is first.
Study summary
The goal of this clinical trial is to learn if Inotuzumab Ozogamicin works to prevent relapses after transplantation in adult high-risk B-cell precursor acute lymphoblastic leukemia treated with the PETHEMA ALL-2025 protocol.
The main questions it aims to answer are:
* Do patients receiving Inotuzumab ozogamicin post-transplantation suffer less relapses than those patients not receiving this therapy (control group) within the ALL-2025 protocol?
* Do patients receiving Inotuzumab ozogamicin show more adverse events and severe adverse events related with this treatment than those patients no receiving this intervention (control group)? Researchers will compare the relapse rate between patients receiving Inotuzumab Ozogamicin post-transplantation and patients not receiving Inotuzumab Ozogamicin post-trasnplantation within the ALL-2025 protocol.
Participants will receive 3 cycles of Inotuzumab Ozogamicin therapy. Treatment will be initiated from day +70 post-transplantation and a minimum interval of 30 days between consecutive administrations.
Eligibility
Primary outcome measure(s)
- Efficacy of Inotuzumab Ozogamicin (InO) in the prevention of relapse in terms of the relapse rate — 24 months
Evaluation of the efficacy of InO in terms of relapse rate, defined as percentage of patients who experience a relapse after achieving complete remission. - Efficacy of InO in the prevention of relapse in terms of the cumulative incidence of relapse (CIR) — 24 months
Evaluation of the efficacy of InO in terms of CIR, defined as time interval between the date of complete remission and the date of relapse, considering any death not related to relapse as a competing event. - Efficacy of InO in the prevention of relapse in terms of the disease-free survival (DFS). — 24 months
Evaluation of the efficacy of InO in terms of DFS, defines as time interval between the date of complete remission and relapse, death from any cause or last follow-up.
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| Complejo Hosp. Regional Virgen del Rocío | Seville | Sevilla | |
| Hospital Universitari i Politecnic La Fe | Valencia | Valencia | |
| ICO-Hospital Germans Trias i Pujol | Badalona | Spain | |
| H. de la Santa Creu I Sant Pau | Barcelona | Spain | |
| C. H. Gregorio Marañón | Madrid | Spain | |
| H. 12 de Octubre | Madrid | Spain | |
| C. H. Regional de Málaga , H. General | Málaga | Spain | |
| C. Asistencial U. de Salamanca | Salamanca | Spain | |
| H Donostia | San Sebastián | Spain | |
| H. Marqués de Valdecilla | Santander | Spain |
More PETHEMA Foundation trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07862946 on ClinicalTrials.gov ↗ ← All trials in Spain