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Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL)

StatusNot Yet Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv5
  2. Start date: Jun 28, 2026 to Aug 28, 2026v4
  3. Start date: Mar 30, 2026 to Jun 28, 2026v3
  4. Start date: Sep 30, 2025 to Mar 30, 2026v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This phase II/III trial tests the addition of daratumumab to chemotherapy for treating patients with newly-diagnosed T-ALL and T-LL. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with daratumumab may kill more cancer cells.
Trial Details
NCT Number NCT07072585
Lead Sponsor Children's Oncology Group
Conditions Stage II T Lymphoblastic Leukemia/Lymphoma, Stage III T Lymphoblastic Leukemia/Lymphoma, Stage IV T Lymphoblastic Leukemia/Lymphoma, T Acute Lymphoblastic Leukemia, T Lymphoblastic Lymphoma
Enrollment 1,708 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov