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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Tafasitamab
Biological/VaccineAntibody vaccination
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: TafasitamabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary endpoint Part I
Determination of maximum tolerated dose of MOR00208 in pediatric patients
Time frame
49 days2
Primary endpoint Part II
Time until hematological relapse (\> 5% leukemic blasts) or increase of MRD ≥ 2 log in bone marrow during an observation time of 545 days accounting for competing risks
Time frame
545 daysSecondary outcomes
1
Pharmakokinetic of MOR00208
Mean plasma concentrations of MOR00208 will be calculated and displayed graphically
Time frame
8 days2
Safety and toxicity of MOR00208 - Part I
Adverse events will be presented in line listings and also in cumulative tabulations
Time frame
49 days3
Treatment success
Rate of patients with treatment success defined as survival without newly emerging MRD or increasing MRD ≥ 2 log in bone marrow or peripheral blood or unacceptable toxicity
Time frame
365 days4
Overall survival
OS from date of first dose until end of follow up at 545 days will be analyzed using Kaplan-Meier-Methods, presenting corresponding statistical parameters and 95% confidence limits and Kaplan-Meier survival curves. Patients alive at 545 days and patients that could not be followed up until 545 days but were seen alive at the last visit will be censored.
Time frame
545 daysSponsors and contacts
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Source ClinicalTrials.gov