Anti-CD19-ALL (Tafasitamab)
A Prospective Phase I/II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Tafasitamab (MOR00208) in Pediatric Patients with Relapsed or Refractory Acute B Lineage Leukemia
Recruiting
Summary
The trial aims to evaluate the safety, clinical toxicity and in vivo immunological effects of Tafasitamab (MOR00208) in pediatric patients with acute lymphoblastic leukemia who showed newly emerging or persistent MRD after a first stem cell transplantation (SCT), received stem cell transplantation without having reached a sufficient molecular remission prior to transplant (defined as MRD ≥10E-4) irrespective of MRD after SCT or underwent a second or subsequent stem cell transplantation irrespective of MRD after SCT.
Main inclusion criteria
- Age: ≥ 3 to < 18 years
- B-lineage (CD19 positive) ALL (B, pro-B, pre-B or c-ALL)
Patients must have either
- underwent a first allogeneic stem cell transplantation with newly emerging or persistent MRD load posttransplant or
- have received stem cell transplantation without having reached a sufficient molecular remission prior to transplant (defined as MRD ≥10E-4) irrespective of MRD after SCT or
- underwent a second or subsequent allogeneic stem cell transplantation irrespective of MRD after SCT
Sponsor
University Hospital Tuebingen