Using Tafasitamab to treat children with relapsed or refractory acute B-lineage leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• 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

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tafasitamab and Rituximab for newly diagnosed follicular lymphoma

  This study tests a combination of tafasitamab and rituximab to treat adults with newly diagnosed follicular lymphoma.

  Recruiting Phase 2 University of Washington · Seattle, Washington · NCT07731789

• Tafasitamab plus Acalabrutinib and Venetoclax for newly treated CLL/SLL

  This phase II study tests a combination of tafasitamab, acalabrutinib, and venetoclax in adults who are newly diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma to see if it is safe and effective.

  Recruiting at 2 sites Phase 2 City of Hope Medical Center · Duarte, California and 1 other locations · NCT07582159

• NK cell therapy with epcoritamab and tafasitamab for relapsed or treatment‑resistant B‑cell lymphoma

  This trial will try whether adding donor-derived ONC-PluReceptor NK cells to the antibodies epcoritamab and tafasitamab helps control relapsed or refractory CD19/CD20-positive B‑cell non‑Hodgkin lymphoma.

  Recruiting Phase 1/2 M.D. Anderson Cancer Center · Houston, Texas · NCT07283679

• Rituximab and Tafasitamab with Allogeneic NK Cells for relapsed or refractory B-cell NHL

  This trial tests whether giving allogeneic NK cells with Rituximab, Tafasitamab, and IL-2 can help people with relapsed or refractory B-cell non-Hodgkin lymphoma who have tried at least two prior therapies.

  Recruiting Phase 1 Case Comprehensive Cancer Center · Cleveland, Ohio and 1 other locations · NCT07225439

• Tafasitamab for adults with primary immune thrombocytopenia or warm autoimmune hemolytic anemia

  This trial will try tafasitamab, an anti‑CD19 antibody, in adults with primary immune thrombocytopenia or warm autoimmune hemolytic anemia to see if it is safe and helps blood counts.

  Recruiting at 39 sites Phase 2 Incyte Corporation · Glendale, Arizona and 38 other locations · NCT07104565

• CTD402 for relapsed or refractory T-ALL and T-LBL

  This trial will test whether a single infusion of CTD402 UCART can be safe and shrink cancer in people age 12 and older with relapsed or refractory T‑cell acute lymphoblastic leukemia or lymphoblastic lymphoma.

  Recruiting at 8 sites Phase 1/2 Imviva Bio · Palo Alto, California and 8 other locations · NCT07070219

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.