Tafasitamab (MOR00208) in Pediatric Patients With Relapsed or Refractory Acute B Lineage Leukemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age3-18
SponsorUniversity Hospital Tuebingen
About this trial
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
Eligibility criteria
Qualifiers
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
KMT2A::AFF1 [t(4;11) rearrangement
Disqualifiers
Frank relapse (>5% leukemic blasts)
Philadelphia chromosome-positive (Ph+) ALL
Ejection fraction <25% on echocardiography
Cystatin C-clearance <40ml/min
Trial design
Treatments tested in this trial
- Tafasitamab
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov