RecruitingPhase 1Phase 2NCT05366218

Tafasitamab (MOR00208) in Pediatric Patients 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


Sponsor

University Hospital Tuebingen

Enrollment

20 participants

Start Date

Mar 8, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 3 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called tafasitamab for children and teenagers with a type of blood cancer called acute B-cell leukemia (ALL) that has come back after a stem cell transplant or CAR-T therapy. Researchers want to know if this drug can help keep the cancer in remission. **You may be eligible if...** - You are between 3 and 17 years old - You have B-cell leukemia (ALL) that tests positive for a marker called CD19 - You have previously had a stem cell transplant or CAR-T therapy - There is evidence of cancer returning in the blood (measurable residual disease) **You may NOT be eligible if...** - You have more than 5% leukemia cells in your bone marrow (frank relapse) - You have Philadelphia chromosome-positive ALL - Your heart function is poor (ejection fraction below 25%) - Your kidney or liver function is severely impaired - You have severe graft-versus-host disease (a complication after transplant) - You are pregnant or breastfeeding - You have a severe active infection including HIV or hepatitis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTafasitamab

Antibody vaccination


Locations(11)

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

University childrens Hospital

Tübingen, Baden-Wurttemberg, Germany

Klinik für Kinder- und Jugendmedizin

Ulm, Baden-Wurttemberg, Germany

Klinikum Dr. von Haunersches Kinderspital

München, Bavaria, Germany

Zentrum für Geburtshilfe, Kinder- und Jugendmedizin

Hamburg, Free and Hanseatic City of Hamburg, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Universitätsmedizin Berlin, Campus Virchow Klinikum

Berlin, Germany

Universitätsklinikum

Essen, Germany

Universitätsklinikum, Klinik für Kinder- und Jugendmedizin

Frankfurt, Germany

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, Germany

Universitäts-Kinderklinik

Würzburg, Germany

View Full Details on ClinicalTrials.gov

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NCT05366218


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