Clinical trial · Interventional
CART-19 Cells For MRD Positive CD19+ ALL
CART-19 Cells For Patients With Minimal Residual Disease (MRD) Positive CD19+ Acute Lymphoblastic Leukemia
NCT03027739CI-TRIAL-00025580CCFMPCAunknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
CART-19 cells has emerged as a powerful targeted immunotherapy, showing striking responses in highly refractory CD19+ acute lymphoblastic leukemia (ALL). This study aims to assess the safety and toxicity of CART-19 cells to patients who are refractory or at highest risk of relapse as defined by MRD+ status.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CART-19 | Biological | Tisagenlecleucel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- CART-19 cells treated
- interventionNames
- Biological: CART-19
Primary outcomes (1)
- measure
- Leukemia free survival
- timeFrame
- 1 year
Secondary outcomes (1)
- measure
- Adverse events that are related to treatment
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Signed written informed consent * Aged between 1-60 years * Patients with MRD positive CD19+ ALL * Cardiac: Left ventricular ejection fraction ≥ 50% * Adequate renal and hepatic function * Performance status: Karnofsky ≥ 70% Exclusion Criteria: * Pregnant or lactating females. * Any co-morbidity precluding the administration of CART-19 cells.
References
Publications (0)
Data not yet available
No reference posted for this study.