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
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 II: to evaluate the time until hematological relapse or increase of MRD
• 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:
• KMT2A::AFF1 \[t(4;11) rearrangement
∙ TP53 alteration (mutation/deletion)
∙ low hypodiploidy (\<40 chromosomes, evident or masked)
∙ TCF3-PBX1 \[t(1;19)\]
∙ TCF3::HLF \[t(17;19)\] and irrespective of MRD after SCT or
⁃ underwent a first allogeneic stem cell transplantation or a CAR T-cell therapy with newly emerging or persistent MRD load posttransplant / post CAR T- cell-treatment 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
• Females of childbearing potential (FCBP1) must agree
‣ to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 3 months before starting study drug, while participating in the study (including dose interruptions), and for at least 3 months after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe
⁃ to abstain from breastfeeding during study participation and 3 months after study drug discontinuation.
• Males must agree
‣ to use a latex condom during any sexual contact with FCBP while participating in the study and for 3 months following discontinuation from this study, even if he has undergone a successful vasectomy
⁃ to refrain from donating semen or sperm during study participation and for 3 months after discontinuation from this study treatment.