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Pomalidomide After CAR T-cell Therapy for the Treatment of Relapsed or Refractory CD19+ B-cell Leukemia or Lymphoma

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Primary completion moved earlier from Oct 2027 to Aug 2027 Show 4 more changesShow less
    • Study completion moved earlier from Oct 2028 to Aug 2028
    • Start date changed from estimate of Sep 1, 2026 to Aug 26, 2026
    • Secondary endpoints: details revised at 3 of 6 entries
    • Eligibility criteria expanded, about 3 words
  2. Start date: Jul 1, 2026 to Sep 1, 2026v3 Show 5 more changesShow less
    • Primary completion pushed from Aug 2027 to Oct 2027
    • Study completion pushed from Aug 2028 to Oct 2028
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: 7 to 6
    • Study description expanded, about 18 words
  3. Recruitment openedv2 Show 4 more changesShow less
    • Start date: May 1, 2026 to Jul 1, 2026
    • Primary completion pushed from Jul 2027 to Aug 2027
    • Study completion pushed from Jul 2028 to Aug 2028
    • Site details revised
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 I trial tests the safety and effectiveness of pomalidomide after CD19 chimeric antigen receptor T-cell (CD19CART) therapy for the treatment of patients with CD19+ B-cell leukemias or lymphomas that have come back after a period of improvement (relapsed) or do not respond to treatment (refractory). Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells and are then re-infused into the patient. Following CAR T-cell infusion, CAR T-cells must expand and persist in the blood stream in order to most effectively treat leukemia/lymphoma. Pomalidomide stops the growth of blood vessels, stimulates the immune system, and may kill cancer cells. Research has shown that drugs like pomalidomide can modify the immune system and increase the number or improve the function of CAR T-cells in the blood. Pomalidomide may enhance the treatment effects of CAR T-cell therapy in patients who have received CD19CART therapy for relapsed or refractory CD19+ B-cell leukemia or lymphoma.
Trial Details
NCT Number NCT07532525
Lead Sponsor University of Michigan Rogel Cancer Center
Conditions
(from sponsor)		 Recurrent B Acute Lymphoblastic Leukemia, Recurrent B-Cell Non-Hodgkin Lymphoma, Refractory B Acute Lymphoblastic Leukemia, Refractory B-Cell Non-Hodgkin Lymphoma
Related terms Burkitt Lymphoma, Lymphoma, B-Cell
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov