Tafasitamab (MOR00208) in Pediatric Patients with Relapsed or Refractory Acute B Lineage Leukemia

Launched by UNIVERSITY HOSPITAL TUEBINGEN · May 4, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Tafasitamab (MOR00208) to see how safe it is and how well it works for children with a type of blood cancer known as acute lymphoblastic leukemia (ALL) that has not responded to previous treatments or has come back after treatment. Specifically, the trial is looking at children who have had a stem cell transplant but still have signs of the disease, called minimal residual disease (MRD). The goal is to find the best dose of the medication and understand how long it takes for the disease to return or for MRD levels to change.

To be eligible for this trial, participants must be children diagnosed with B-lineage ALL and have either had a stem cell transplant with ongoing MRD or have not fully achieved remission before their transplant. Additionally, they must meet certain health criteria, such as not having severe infections or significant heart or liver problems. Participants will receive the study medication and will be monitored closely for side effects and how well the treatment is working. It's important for families to discuss this option with their healthcare team to see if it’s a good fit for their child.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 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/ 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.