TAFASITAMAB for Acute B-lineage lymphoblastic leukemia | Acute lymphoblastic leukemia

Inclusion criteria

• {"criterion_text":"- Age >=3 to <18 years\n- B-lineage (CD19 positive) ALL (B, pro-B, pre-B or c-ALL)\n- Refractory to standard treatment or with relapsed disease\n- •\tPatients must have either underwent a first allogeneic stem cell transplantation after relapse with one of the following very high-risk somatic molecular alterations - KMT2A::AFF1 [t(4;11) rearrangement, TP53 alteration (mutation/deletion), low hypodiploidy (<40 chromosomes, evident or masked), TCF3-PBX1 [t(1;19)], TCF3::HLF [t(17;19)] - and irrespective of MRD after SCT or underwent a first allogeneic stem cell transplantation or a CAR T-cell therapy with newly emerging or persistent MRD load posttransplant / post CAR T-cell-treatment 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\n- Informed consent must be given by patients or legal representatives"}

Exclusion criteria

• {"criterion_text":"- Frank relapse (>5% leukemic blasts)\n- Signs of autoimmune disease (i.e. idiopathic thrombocytopenic purpura, autoimmune hemolytic anemia)\n- Subjects that do not agree to refrain from donating blood while on study drug\n- Concurrent severe or uncontrolled medical disease which by assessment of the treating physician could compromise participation in the study\n- Women during pregnancy and lactation\n- 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.\n- Ejection fraction <25% on echocardiography\n- Cystatin C-clearance <40ml/min\n- Liver function abnormalities with bilirubin >4 mg/dL and elevation of transaminases higher than 400 U/L\n- Severe infection (HIV, Chronic active viral hepatitis), tests have to be conducted at screening\n- Acute GvHD III-IV or extensive chronic GvHD\n- The following immunosuppressive drugs (≥ 1 week of administration): steroids ≥ 1mg/kg body weight, cytostatics (except intrathecal/intracerebroventricular application for CNS treatment)\n- Application of other experimental therapy modalities in the last 4 weeks\n- Significant psychiatric disabilities, uncontrolled seizure disorders or severe peripheral neuropathy/ leukencephalopathy"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured as time (days) from baseline until occurrence of hematological relapse defined as >5% leukemic blasts or increase of minimal residual disease (MRD) ≥2 log in bone marrow within an observation time of 545 days; competing risks accounted for."}

Secondary endpoints

• {"endpoint_text":"- 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.\n- Overall survival.\n- 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\n- Cytotoxicity of patient derived PBMCs against cell lines (NALM) and cryopreserved autologous blasts at several time points.\n- Pharmacokinetic of MOR00208.\n- Safety endpoint: Any toxicity irrespective of grade\n- Safety endpoint: Number of Deaths\n- Safety endpoint: Number of relapses\n- Safety endpoint: Adverse events will be presented in line listings and also in cumulative tabulations.","definition_or_measurement_approach":"Rate of patients with treatment success: proportion surviving without newly emerging MRD or MRD increase ≥2 log in bone marrow/peripheral blood or unacceptable toxicity; Overall survival: time to death from any cause; MRD reduction: proportion with ≥1 log MRD decrease versus baseline (between SCT and treatment start); B cell numbers: measured by flow cytometry in peripheral blood until end of follow-up; Cytotoxicity: ex vivo assays of patient-derived PBMCs against NALM cell lines and autologous blasts at multiple time points; Pharmacokinetics: plasma concentrations of MOR00208 measured pre-dose, end-of-infusion, 1h post-dose, 24h post-dose and pre-next-dose at infusion No.1 and 7; Safety endpoints: AEs/toxicities recorded and presented in listings and cumulative tabulations; counts of deaths and relapses."}

Germany

Earliest CTIS Part Ii Submission Date

23-04-2024

Latest Decision Or Authorization Date

30-01-2026

Processing Time Days

647

Number Of Sites

12

Number Of Participants

20

Primary sponsor

Full Name

Universitaetsklinikum Tuebingen AöR

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany

Contract research organisations

Name

Almac

Responsibilities

MIA (IMP) 20377: IMP manufacturing, secondary packaging, labelling and testing (including QP release)

Third parties

• {"country":"Switzerland","full_name":"Incyte Biosciences International Sàrl","duties_or_roles":"Source of monetary support","organisation_type":""}