Tafasitamab (MOR00208) in Pediatric Patients With Relapsed or Refractory Acute B Lineage Leukemia

The objective of the trial is to evaluate the safety, clinical toxicity and in vivo immunological effects of MOR00208 in pediatric patients with acute lymphoblastic leukemia who showed newly emerging or persistent MRD after a first stem cell transplantation, 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. Part I: to determine the recommended dose of MOR00208 in pediatric patients Part I

Trial Details

NCT ID
NCT05366218
Phase
PHASE1 / PHASE2
Sponsor
University Hospital Tuebingen
Status
RECRUITING
Cancer Type
Acute Lymphoblastic (ALL) Leukemia
Interventions
  • Tafasitamab
Locations (sample)
  • Freiburg im Breisgau, Baden-Wurttemberg, Germany|47.9959,7.85222
  • Tübingen, Baden-Wurttemberg, Germany|48.52266,9.05222
  • Ulm, Baden-Wurttemberg, Germany|48.39841,9.99155
  • München, Bavaria, Germany|48.69668,13.46314
  • Hamburg, Free and Hanseatic City of Hamburg, Germany|53.55073,9.99302

Key Eligibility Criteria

  • Age ≥ 3 years and \< 18 years at enrollment
  • B-lineage (CD19 positive) ALL (B, pro-B, pre-B or c-ALL)
  • Patients must have either
  • underwent a first allogeneic stem cell transplantation after relapse with one of the following very high-risk somatic molecular alterations:

For full eligibility, visit ClinicalTrials.gov.

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