Using Tafasitamab to treat children with relapsed or refractory acute B-lineage leukemia
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
This study is testing a new treatment called Tafasitamab to see if it can help children with hard-to-treat acute leukemia stay healthy longer after their stem cell transplant.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | University Hospital Tuebingen Academic / other |
| Drugs / interventions | CAR T, tafasitamab, chemotherapy |
| Locations | 11 sites (Freiburg im Breisgau, Baden-Wurttemberg and 10 other locations) |
| Trial ID | NCT05366218 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of Tafasitamab, an anti-CD19 antibody, in pediatric patients suffering from relapsed or refractory acute lymphoblastic leukemia (ALL). The study is divided into two parts: the first part aims to determine the recommended dose of Tafasitamab, while the second part assesses the time until hematological relapse or an increase in minimal residual disease (MRD). The trial focuses on patients who have undergone stem cell transplantation and have either persistent MRD or did not achieve sufficient molecular remission prior to transplantation. The goal is to improve long-term survival rates by reducing the likelihood of relapse in this high-risk population.
Who should consider this trial
Good fit: Ideal candidates include children with B-lineage ALL who have experienced relapses after stem cell transplantation or have persistent MRD.
Not a fit: Patients who do not have B-lineage ALL or those who have not undergone stem cell transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates for pediatric patients with high-risk acute lymphoblastic leukemia.
How similar studies have performed: Previous compassionate use cases of Tafasitamab in pediatric patients have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Frank relapse (\>5% leukemic blasts)
* Philadelphia chromosome-positive (Ph+) ALL
* Ejection fraction \<25% on echocardiography
* Cystatin C-clearance \<40ml/min
* Liver function abnormalities with bilirubin \>4 mg/dL and elevation of transaminases higher than 400 U/L
* Severe infection (HIV, Chronic active viral hepatitis), tests have to be conducted at screening
* Acute GvHD III-IV or extensive chronic GvHD
* The following immunosuppressive drugs (≥ 1 week of administration):
steroids ≥ 1mg/kg body weight, cytostatics (except intrathecal/ intracerebroventricular application for CNS treatment)
* Application of other experimental therapy modalities in the last 4 weeks
* Significant psychiatric disabilities, uncontrolled seizure disorders or severe peripheral neuropathy/ leukoencephalopathy
* Signs of autoimmune disease (i.e. idiopathic thrombocytopenic purpura, autoimmune hemolytic anemia)
* Subjects that do not agree to refrain from donating blood while on study drug
* Concurrent severe or uncontrolled medical disease which by assessment of the treating physician could compromise participation in the study
* Women during pregnancy and lactation
* History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
Where this trial is running
Freiburg im Breisgau, Baden-Wurttemberg and 10 other locations
- Universitätsklinikum Freiburg — Freiburg im Breisgau, Baden-Wurttemberg, Germany (Recruiting)
- University childrens Hospital — Tübingen, Baden-Wurttemberg, Germany (Recruiting)
- Klinik für Kinder- und Jugendmedizin — Ulm, Baden-Wurttemberg, Germany (Recruiting)
- Klinikum Dr. von Haunersches Kinderspital — München, Bavaria, Germany (Not_yet_recruiting)
- Zentrum für Geburtshilfe, Kinder- und Jugendmedizin — Hamburg, Free and Hanseatic City of Hamburg, Germany (Recruiting)
- Universitätsklinikum Düsseldorf — Düsseldorf, North Rhine-Westphalia, Germany (Recruiting)
- Universitätsmedizin Berlin, Campus Virchow Klinikum — Berlin, Germany (Recruiting)
- Universitätsklinikum — Essen, Germany (Not_yet_recruiting)
- Universitätsklinikum, Klinik für Kinder- und Jugendmedizin — Frankfurt, Germany (Not_yet_recruiting)
- Universitätsklinikum Schleswig-Holstein, Campus Kiel — Kiel, Germany (Recruiting)
- Universitäts-Kinderklinik — Würzburg, Germany (Recruiting)
Study contacts
- Principal investigator: Peter Lang, Prof. — University Childrens Hospital Tübingen
- Study coordinator: Peter Lang, Prof.
- Email: peter.lang@med.uni-tuebingen.de
- Phone: 0049 7071 2984744
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.