B-lineage (CD19 positive) ALL (B, pro-B, pre-B or c-ALL) refractory to standard treatment or with relapsed disease MedDRA version: 20.0 Level: LLT Classification code 10024338 Term: Leukemia lymphoblastic acute System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Tafasitamab
Product Name: Tafasitamab
Product Code: MOR00208
Pharmaceutical Form: Powder for concentrate for solution for infusion
Sponsors
University Hospital Tuebingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Frank relapse (>5% leukemic blasts) • Philadelphia chromosome-positive (Ph+) ALL • Ejection fraction 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part I: To determine the recommended dose of MOR00208 in pediatric patients on the basis of the maximum tolerated dose (MTD). Part II: To evaluate the time until hematological relapse (> 5% leukemic blasts) or increase of MRD = 2 log in bone marrow during an observation time of 545 days accounting for competing risks.;Secondary Objective: Part I: 1.To evaluate the pharmacokinetics with measurement of plasma concentrations of MOR00208 2.Assessment of Safety of MOR00208 by NCI Common Toxicity Criteria, version 5.0. Part II: 1.To determine the rate of patients with "Success of treatment", defined as survival without newly emerging MRD or increasing MRD = 2 log in bone marrow or peripheral blood or unacceptable toxicity/infections. 2.To evaluate the overall survival. 3.To evaluate changes in minimal residual disease during and after treatment in bone marrow aspirates with evaluation of the rate of patients with MRD reduction of at least 1 log at any time point compared to baseline. 4.To evaluate changes in peripheral B cell numbers by flow cytometry in peripheral blood until the end of follow-up. 5.To evaluate the cytotoxicity of patient derived PBMCs against cell lines (NALM) and cryopreserved autologous blasts. 6.Assessment of Safety of MOR00208 by NCI Common Toxicity Criteria, version 5.0.;Primary end point(s): 1. Recommended dose of MOR00208 in pediatric patients, determined on the basis of the maximum tolerated dose (MTD) 2. Time until hematological relapse (> 5% leukemic blasts) or increase of MRD = 2 log in bone marrow during an observation time of 545 days accounting for competing risks.;Timepoint(s) of evaluation of this end point: 1. End of Part I. 2. Day 545. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Pharmacokinetic of MOR00208 - Safety and toxicity of MOR00208 - Rate of patients with treatment success defined as survival without newly emerging MRD or increasing MRD = 2 log in bone marrow or peripheral blood or unacceptable toxicity. - Overall survival. - Rate of patients with MRD reduction of at least 1 log at any time point compared to basline MRD measurement between SCT and start of study treatment. - B cell numbers at several time points. - Cytotoxicity of patient derived PBMCs against cell lines (NALM) and cryopreserved autologous blasts at several time points. - Safety and toxicity of MOR00208 Safety endpoints: • Any toxicity irrespective of grade • Number of Deaths • Number of Relapses • Adverse events will be presented in line listings and also in cumulative tabulations.;Timepoint(s) of evaluation of this end point: Day 365 for the rate of patients with treatment success. Day 545 for the other endpoints. | — |
Countries
Germany
Contacts
Public ContactCPCS
Center for Pediatric Clinical Studies
Outcome results
None listed