Clinical trial · Interventional
Tisagenlecleucel vs Blinatumomab or Inotuzumab for Patients With Relapsed/Refractory B-cell Precursor Acute Lymphoblastic Leukemia
Tisagenlecleucel Versus Blinatumomab or Inotuzumab for Adult Patients With Relapsed/Refractory B-cell Precursor Acute Lymphoblastic Leukemia: A Randomized Open Label, Multicenter, Phase III Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Novartis is no longer pursuing this study because of planned investigation of novel CAR-T therapies in this patient population.
Summary
Brief summary (as posted)
This trial aims to compare the benefits and risks of tisagenlecleucel to blinatumomab or inotuzumab in adult patients with relapsed or refractory ALL. This trial investigates tisagenlecleucel as an additional treatment option for this patient population with high unmet medical need.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blinatumomab | Drug | Blinatumomab | ALIAS |
| Inotuzumab | Drug | — | UNRESOLVED |
| Tisagenlecleucel | Biological | Tisagenlecleucel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tisagenlecleucel arm
- description
- Patient to receive tisagenlecleucel after optional bridging therapy and lymphodepleting chemotherapy.
- interventionNames
- Biological: Tisagenlecleucel
- type
- ACTIVE_COMPARATOR
- label
- Control arm
- description
- blinatumomab or inotuzumab per investigator's discretion after optional bridging chemotherapy
- interventionNames
- Drug: Blinatumomab
- Drug: Inotuzumab
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed informed consent. 2. Age ≥ 18 years. 3. Subject with CD19-expressing B-ALL. 4. Adequate organ function. 5. Patients considered in any of the following settings are eligible: 1. Untreated first or second relapse 2. Refractory to primary induction therapy 3. Refractory to first salvage therapy or 4. Relapse after allogenic stem cell transplant. Exclusion Criteria: 1. Patients presenting with untreated first relapse of ALL more than 24 months after initial diagnosis 2. Presence of extra-medullary disease. 3. History or presence of clinically relevant CNS pathology, or uncontrolled CNS leukemia. 4. History of Veno-occlusive Disease (VOD). 5. Active neurological autoimmune or inflammatory disorders. 6. Active acute Graft-versus-Host Disease (GvHD), grade 2-4. Other protocol-defined Inclusion/Exclusion may apply.
References
Publications (0)
Data not yet available