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

Conditions

Leukemia in childhood

Brief summary

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.

Detailed description

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, Cytotoxicity of patient derived PBMCs against cell lines (NALM) and cryopreserved autologous blasts at several time points., Pharmacokinetic of MOR00208., Safety endpoint: Any toxicity irrespective of grade, Safety endpoint: Number of Deaths, Safety endpoint: Number of relapses, Safety endpoint: Adverse events will be presented in line listings and also in cumulative tabulations.

Related papers

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Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGMINJUVI 200 mg powder for concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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, Cytotoxicity of patient derived PBMCs against cell lines (NALM) and cryopreserved autologous blasts at several time points., Pharmacokinetic of MOR00208., Safety endpoint: Any toxicity irrespective of grade, Safety endpoint: Number of Deaths, Safety endpoint: Number of relapses, Safety endpoint: Adverse events will be presented in line listings and also in cumulative tabulations.	—

Measure

Time frame

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, Cytotoxicity of patient derived PBMCs against cell lines (NALM) and cryopreserved autologous blasts at several time points., Pharmacokinetic of MOR00208., Safety endpoint: Any toxicity irrespective of grade, Safety endpoint: Number of Deaths, Safety endpoint: Number of relapses, Safety endpoint: Adverse events will be presented in line listings and also in cumulative tabulations.

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Countries

Germany

Outcome results

None listed