Anti-CD19-ALL

Author:  Dr. med.Michael Abele, Last modification: 2024/03/27 https://kinderkrebsinfo.de/doi/e269391

Anti-CD19-ALL 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
Disease Pediatric Patients with Relapsed or Refractory Acute B Lineage Leukemia after stemcell transplatation (HSCT)
Type Prospective, multicenter, non-randomized, single arm phase I/II
Rationale / Objectives

The primary study objective is to assess whether treatment with Tafasitamab prolongs the mean time to eventual hematologic relapse or increase in residual leukemia burden (MRD) or reduces the frequency of relapse.
Therapy / Study arms

Treatment with tafasitamab weekly or 2-weekly for a treatment period of 12 months, followed by follow-up for 6 months.
Inclusion Criteria
  • Age 0 - 18 years
  • Patients must have either undergone allogeneic stem cell transplantation with new-onset or persistent MRD post-transplant or
  • Have received a stem cell transplant without having achieved sufficient molecular remission prior to transplantation (defined as MRD ≥ 10E-4) or
  • Have undergone a ≥ 2nd allogeneic stem cell transplant.
  • Presence of an informed consent for study participation, data collection, data storage, and data use
  • Use of highly effective contraceptives in sexually active study participants.
Exclusion Criteria
  • Open relapse ( > 5 % leukemic blasts).
  • Ejection fraction less than 25 % on echocardiography
  • Cystatin C clearance less than 40ml/min
  • Liver failure with bilirubin > 4 mg/dl and transaminase elevation above 400 U/l
  • Severe infections (HIV, chronic active viral hepatitis)
  • Acute GvHD III-IV or severe chronic GvHD
  • The following immunosuppressive medications (≥ 1 week): Steroids ≥ 1mg prednisolone equivalent/kg body weight, cytostatics (except intrathecal/intracerebroventricular use for CNS treatment)
  • Use of other experimental therapeutic modalities in the past 4 weeks.
Recruitment Between 20 und 39 patients in 3 years
Status Start of recruitmen 03/2023
EudraCT 2022-000557-88
Entry Study Register ClinicalTrials.gov: NCT05366218
Principal Investigator Prof. Dr. med. Peter Lang / Dr. med. Michael Abele
E-Mail cd19-studie@med.uni-tuebingen.de
Contact

Studienkoordination / stellv. Prüfer

Dr. med. Michael Abele Universitätsklinik für Kinder- und Jugendmedizin Tübingen Hoppe-Seyler-Str. 1 72076 Tübingen Telefon +49 7071 29 83781 (Pforte Kinderklinik)

Participants GPOH-Centers: Tübingen, Freiburg, Ulm, Berlin, Würzburg, Kiel, Essen, Düsseldorf, Frankfurt, Hamburg, München (LMU/von Haunersches Kinderspital)
Weitere Informationen Sponsor: Universitätsklinikum Tübingen