Actively Recruiting
Tafasitamab (MOR00208) in Pediatric Patients With Relapsed or Refractory Acute B Lineage Leukemia
Led by University Hospital Tuebingen · Updated on 2026-02-05
20
Participants Needed
11
Research Sites
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Tafasitamab (MOR00208) in Pediatric Patients With Relapsed or Refractory Acute B Lineage Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 3 years and under 18 years at enrollment
- Diagnosis of B-lineage (CD19 positive) acute lymphoblastic leukemia (B, pro-B, pre-B or c-ALL)
- Patients who have undergone a first allogeneic stem cell transplantation after relapse with very high-risk molecular alterations (KMT2A::AFF1, TP53 alteration, low hypodiploidy, TCF3-PBX1, TCF3::HLF) regardless of MRD after SCT
- Patients who have undergone a first allogeneic stem cell transplantation or CAR T-cell therapy with newly emerging or persistent MRD after treatment
- Patients who received stem cell transplantation without sufficient molecular remission prior to transplant (MRD 6510E-4) regardless of MRD after SCT
- Patients who underwent a second or subsequent allogeneic stem cell transplantation regardless of MRD after SCT
- Females of childbearing potential must agree to use two reliable contraception methods or abstain from heterosexual contact 3 months before, during, and 3 months after treatment and agree to pregnancy testing
- Females must agree to abstain from breastfeeding during study participation and 3 months after treatment
- Males must agree to use latex condoms during sexual contact with females of childbearing potential during study and 3 months after, and to refrain from semen donation during study and 3 months after
You will not qualify if you...
- Frank relapse defined as more than 5% leukemic blasts
- Philadelphia chromosome-positive (Ph+) ALL
- Ejection fraction less than 25% on echocardiography
- Cystatin C-clearance less than 40 ml/min
- Liver abnormalities with bilirubin above 4 mg/dL and transaminases higher than 400 U/L
- Severe infections including HIV or chronic active viral hepatitis
- Acute graft-versus-host disease (GvHD) grade III-IV or extensive chronic GvHD
- Use of immunosuppressive drugs (steroids 651 mg/kg, cytostatics except intrathecal/intracerebroventricular) for 1 week or more
- Use of other experimental therapies within 4 weeks prior to study
- Significant psychiatric disabilities, uncontrolled seizures, or severe peripheral neuropathy/leukoencephalopathy
- Signs of autoimmune disease such as idiopathic thrombocytopenic purpura or autoimmune hemolytic anemia
- Refusal to refrain from blood donation while on study drug
- Concurrent severe or uncontrolled medical conditions that may interfere with study participation
- Pregnancy or lactation
- History of hypersensitivity to tafasitamab or similar drugs or excipients in the drug formulation
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Actively Recruiting
2
University childrens Hospital
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
3
Klinik für Kinder- und Jugendmedizin
Ulm, Baden-Wurttemberg, Germany, 89070
Actively Recruiting
4
Klinikum Dr. von Haunersches Kinderspital
München, Bavaria, Germany, 80337
Not Yet Recruiting
5
Zentrum für Geburtshilfe, Kinder- und Jugendmedizin
Hamburg, Free and Hanseatic City of Hamburg, Germany, 20246
Actively Recruiting
6
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany, 40225
Actively Recruiting
7
Universitätsmedizin Berlin, Campus Virchow Klinikum
Berlin, Germany, 13353
Actively Recruiting
8
Universitätsklinikum
Essen, Germany, 45147
Not Yet Recruiting
9
Universitätsklinikum, Klinik für Kinder- und Jugendmedizin
Frankfurt, Germany, 60590
Not Yet Recruiting
10
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24105
Actively Recruiting
11
Universitäts-Kinderklinik
Würzburg, Germany, 97080
Actively Recruiting
Research Team
P
Peter Lang, Prof.
CONTACT
M
Michael Abele, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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