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

Study acronym: Anti-CD19-ALL
StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Primary completion date: Mar 2027 to Jul 2028
    • Study completion date: Mar 2027 to Feb 2029
    • Eligibility criteria expanded, about 64 words
    v7
  2. Site details revised at 1 of 11 sitesv6
  3. Study sites: 6 to 11v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 6
    • Start date changed from estimate of Dec 2022 to Mar 8, 2023
    v4
  5. Primary endpoints: 1 to 2
    • Eligibility criteria shortened, about 8 words
    • Secondary endpoints: 6 to 8
    v3
  6. Start date: Sep 2022 to Dec 2022v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The objective of the trial is to evaluate the safety, clinical toxicity and in vivo immunological effects of MOR00208 in pediatric patients with acute lymphoblastic leukemia who showed newly emerging or persistent MRD after a first stem cell transplantation, 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 stem cell transplantation irrespective of MRD after SCT. Part I: to determine the recommended dose of MOR00208 in pediatric patients Part II: to evaluate the time until hematological relapse or increase of MRD
Trial Details
NCT Number NCT05366218
Lead Sponsor University Hospital Tuebingen
Conditions
(from sponsor)		 ALL, Childhood B-Cell, Acute Lymphoid Leukemia Relapse, Acute Lymphocytic Leukemia Refractory
Related terms Recurrence
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov