Status:
RECRUITING
Tafasitamab (MOR00208) in Pediatric Patients with Relapsed or Refractory Acute B Lineage Leukemia
Lead Sponsor:
University Hospital Tuebingen
Conditions:
ALL, Childhood B-Cell
Acute Lymphoid Leukemia Relapse
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
Acute lymphoblastic leukemia is the most common malignancy in children. In patients with \> 2nd relapse or in patients who relapse after previous stem cell transplantation (SCT), conventional chemothe...
Eligibility Criteria
Inclusion
- B-lineage (CD19 positive) ALL (B, pro-B, pre-B or c-ALL)
- Patients must have either
- underwent a first allogeneic stem cell transplantation with newly emerging or persistent MRD load posttransplant 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
- 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.
Key Trial Info
Start Date :
March 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05366218
Start Date
March 8 2023
End Date
March 1 2027
Last Update
December 12 2024
Active Locations (11)
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1
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
2
University childrens Hospital
Tübingen, Baden-Wurttemberg, Germany, 72076
3
Klinik für Kinder- und Jugendmedizin
Ulm, Baden-Wurttemberg, Germany, 89070
4
Klinikum Dr. von Haunersches Kinderspital
München, Bavaria, Germany, 80337