Tafasitamab against childhood leukemia

Phase 1

• Conditions: B-lineage (CD19 positive) ALL (B, pro-B, pre-B or c-ALL) refractory to standard treatment or with relapsed disease; MedDRA version: 20.0Level: LLTClassification code 10024338Term: Leukemia lymphoblastic acuteSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2022-000557-88-DE
• Lead Sponsor: niversity Hospital Tuebingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

•Age < 18 years at enrollment
oonly children = 3 years at enrollment will be enrolled prior to the identification of the recommended Phase II dose (maximum tolerated dose, MTD)
•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
•Informed consent must be given by patients or legal representatives
Are the trial subjects under 18? yes
Number of subjects for this age range: 39
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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/ leukencephalopathy
•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified