Actively Recruiting
A Phase I/II Study to Evaluate Safety and Efficacy of Tafasitamab (MOR00208) in Children With Relapsed or Refractory Acute B-Lineage Leukemia
Led by University Hospital Tuebingen · Updated on 2026-02-05
20
Participants Needed
11
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, clinical toxicity, and immune effects of the antibody tafasitamab (MOR00208) in children aged 3 to under 18 with relapsed or refractory acute B-lineage lymphoblastic leukemia, especially those who have persistent or new minimal residual disease (MRD) after stem cell transplantation or who underwent multiple transplantations. This study aims to find a new therapy approach for very high-risk pediatric patients, as current treatment options show low event-free survival rates and a high risk of relapse. The trial has two parts: first, it determines the recommended dose of tafasitamab by escalating doses among participants and monitoring side effects; second, it evaluates the drug's efficacy and continued safety at the established dose. Tafasitamab is given intravenously over 2 to 3 hours every two weeks during 28-day cycles, with additional doses in the first few cycles to optimize treatment. This antibody therapy is intended to reduce relapse risk after transplantation in these high-risk children. Participants will attend regular visits for treatment infusions and monitoring, including safety checks, laboratory tests, and assessments of leukemia status and immune responses. Researchers will measure time until relapse or MRD increase, drug side effects, pharmacokinetics, overall survival, and immune cell changes over follow-up periods up to approximately 18 months. Study participation involves close medical supervision to assess treatment effects and possible toxicities while aiming to improve long-term outcomes for these patients.
CONDITIONS
Brief 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 or older and younger than 18 years at enrollment
- Diagnosis of B-lineage (CD19 positive) acute lymphoblastic leukemia (B, pro-B, pre-B, or c-ALL)
- Have undergone a first allogeneic stem cell transplantation after relapse with very high-risk molecular alterations or
- Have undergone a first allogeneic stem cell transplantation or CAR T-cell therapy with newly emerging or persistent minimal residual disease (MRD) post-treatment or
- Received stem cell transplantation without sufficient molecular remission before transplant (MRD \u226510E-4) or
- Underwent a second or subsequent allogeneic stem cell transplantation
- Females of childbearing potential must agree to use two reliable contraception methods or abstain from heterosexual contact during and for 3 months after treatment, and agree to pregnancy testing
- Females must abstain from breastfeeding during participation and for 3 months after treatment
- Males must use latex condoms during sexual contact with females of childbearing potential and refrain from donating sperm during and for 3 months after treatment
You will not qualify if you...
- Having frank relapse with more than 5% leukemic blasts
- Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia
- Ejection fraction below 25% on echocardiography
- Cystatin C-clearance less than 40 ml/min
- Liver abnormalities with bilirubin over 4 mg/dL or transaminases above 400 U/L
- Severe infections such as HIV or chronic active viral hepatitis
- Acute graft-versus-host disease (GvHD) grade III-IV or extensive chronic GvHD
- Use of immunosuppressive drugs at doses of steroids \u22651 mg/kg or cytostatics (except certain CNS treatments) for 1 week or more
- Use of other experimental therapies within the last 4 weeks
- Significant psychiatric disabilities, uncontrolled seizures, or severe neuropathy/leukoencephalopathy
- Signs of autoimmune diseases like idiopathic thrombocytopenic purpura or autoimmune hemolytic anemia
- Refusal to refrain from blood donation during study drug treatment
- Severe or uncontrolled medical diseases compromising participation
- Pregnancy or lactation
- History of hypersensitivity to tafasitamab or similar drugs or any excipients in the study drug formulation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 3 months (3 cycles of 28 days each)
Participants receive tafasitamab infusions administered intravenously over 2-3 hours on a bi-weekly schedule. During the first 28-day cycle, additional doses are given on Days 4, 8, and 22. In cycles 2 and 3, additional doses are given on Days 8 and 22. This treatment aims to reduce the likelihood of leukemia relapse after stem cell transplantation.
Multiple infusions on Days 1, 4, 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycles 2 and 3
Duration - Up to approximately 18 months after treatment start
Participants are monitored for safety, side effects, and treatment efficacy including long-term outcomes such as survival and minimal residual disease reduction.
Periodic visits for safety and efficacy assessments over 545 days
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.
M
Michael Abele, Dr.
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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