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Studies

Interventional Recruiting Phase 2

NCT05289687 on ClinicalTrials.gov

Daratumumab for Chemotherapy-Refractory Minimal Residual Disease in T Cell ALL

Official title: A Phase II Study of Daratumumab-Hyaluronidase for Chemotherapy-Relapsed/Refractory Minimal Residual Disease (MRD) in T Cell Acute Lymphoblastic Leukemia (T-ALL

  • Sponsor: Eastern Cooperative Oncology Group
  • Collaborators: Janssen, LP
  • Enrollment: 20 (Estimated)
  • Study start: 2023-05-25 (Actual)
  • Primary completion: 2027-06-30 (Estimated)
  • Study completion: 2027-06-30 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • InterventionModelDescription: This is a single arm study of daratumumab-hyaluronidase in T-ALL patients in morphologic CR with persistent or relapsed MRD. MRD will be assessed centrally for eligibility and response by flow cytometry. All patients will receive daratumumab-hyaluronidase once weekly for up to 4 doses during Course 1. .
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

In this study, the investigators are hypothesizing that daratumumab-hyaluronidase will effectively treat T-ALL in patients who have persistent or recurrent MRD following treatment with chemotherapy.

Conditions

  • T-cell Acute Lymphoblastic Leukemia

Intervention / Treatment

  • Drug: Daratumumab / Hyaluronidase Injection

Primary Outcome Measures

  • Complete Remission (CR) (Day 29)
    Requires that all of the following be present. * Peripheral Blood Counts * Neutrophil count ≥ 1,000/µL. * Platelet count ≥ 100,000/µL. * Reduced hemoglobin concentration or hematocrit has no bearing on remission status. * Leukemic blasts must not be present in the peripheral blood. * Bone Marrow Aspirate and Biopsy * Cellularity of bone marrow biopsy must be \> 20% with maturation of all cell lines. * ≤ 5% T lymphoblasts by flow cytometry. * Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present.
  • Complete Remission (CR) (Day 64)
    Requires that all of the following be present. * Peripheral Blood Counts * Neutrophil count ≥ 1,000/µL. * Platelet count ≥ 100,000/µL. * Reduced hemoglobin concentration or hematocrit has no bearing on remission status. * Leukemic blasts must not be present in the peripheral blood. * Bone Marrow Aspirate and Biopsy * Cellularity of bone marrow biopsy must be \> 20% with maturation of all cell lines. * ≤ 5% T lymphoblasts by flow cytometry. * Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present.
  • Complete Response with Partial Count Recovery (CRh) (Day 29)
    The same as for CR except with unsupported platelets \> 50,000/μL, hemoglobin \> 7 g/dL, and absolute neutrophil count \> 500/μL.
  • Complete Response with Partial Count Recovery (CRh) (Day 64)
    The same as for CR except with unsupported platelets \> 50,000/μL, hemoglobin \> 7 g/dL, and absolute neutrophil count \> 500/μL.
  • Complete Remission incomplete (CRi) (Day 29)
    All the same response criteria in peripheral blood and bone marrow as CR with the exception that there is incomplete platelet recovery (platelets \> 75,000/uL but \< 100,000/μL independent of platelet transfusions) or incomplete neutrophil count recovery \> 750/uL but \< 1000/μL.
  • Complete Remission incomplete (CRi) (Day 64)
    All the same response criteria in peripheral blood and bone marrow as CR with the exception that there is incomplete platelet recovery (platelets \> 75,000/uL but \< 100,000/μL independent of platelet transfusions) or incomplete neutrophil count recovery \> 750/uL but \< 1000/μL.
  • Minimal Residual Disease Negativity (MRD-) (Day 29)
    Bone marrow lymphoblast percent \< 0.01% (\< 10-4) by flow cytometry in a patient that fulfills count requirements for CR/CRh/CRi..
  • Minimal Residual Disease Negativity (MRD-) (Day 64)
    Bone marrow lymphoblast percent \< 0.01% (\< 10-4) by flow cytometry in a patient that fulfills count requirements for CR/CRh/CRi..
  • Morphologic Relapse (Day 29)
    Bone Marrow Aspirate and Biopsy * Presence of \> 5% T lympho-blasts, not attributable to another cause (e.g., bone marrow regeneration). * If there are no circulating blasts and the bone marrow contains 5% to 20% blasts, then a repeat bone marrow performed ≥ 1 week later documenting more than 5% blasts is necessary to meet the criteria for relapse.
  • MRD Relapse (Day 29)
    • Relapse following MRD negativity is defined as bone marrow T lymphoblast percent ≥ 0.01% (10-4).
  • Morphologic Relapse (Day 64)
    Bone Marrow Aspirate and Biopsy * Presence of \> 5% T lympho-blasts, not attributable to another cause (e.g., bone marrow regeneration). * If there are no circulating blasts and the bone marrow contains 5% to 20% blasts, then a repeat bone marrow performed ≥ 1 week later documenting more than 5% blasts is necessary to meet the criteria for relapse.
  • MRD Relapse (Day 64)
    • Relapse following MRD negativity is defined as bone marrow T lymphoblast percent ≥ 0.01% (10-4).
  • Refractory (Day 29)
    Failure to achieve MRD negativity as defined by bone marrow with CR/CRh/CRi with T lymphoblast percent ≥ 0.01% (10-4).
  • Refractory (Day 64)
    Failure to achieve MRD negativity as defined by bone marrow with CR/CRh/CRi with T lymphoblast percent ≥ 0.01% (10-4).

Countries

United States

Locations and Investigators

  • Northwestern, Chicago, United States (Recruiting)
    • Shira Dinner, MD

Study Officials