Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse

Sponsor
National Cancer Institute (NCI)
Study ID
NCT07437963
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Recurrent Ganglioneuroblastoma
  • Recurrent Neuroblastoma
  • Refractory Ganglioneuroblastoma
  • Refractory Neuroblastoma

Eligibility Criteria

Sex
ALL
Age
1 Year - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Cyclophosphamide — DRUG
    Given IV
  • Dinutuximab — BIOLOGICAL
    Given IV
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • FDG-Positron Emission Tomography — PROCEDURE
    Undergo FDG-PET
  • Iberdomide — DRUG
    Given PO, NG-tube, or G-tube
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Nuclear Radiology Imaging Procedure — RADIATION
    Undergo 123I-MIBG scans
  • Sargramostim — BIOLOGICAL
    Given SC or IV
  • Topotecan — DRUG
    Given IV

Study Details

This phase I/II trial studies the side effects and best dose of iberdomide when given together with chemoimmunotherapy drugs and to see how well it works in treating patients with neuroblastoma that has come back after a period of improvement (relapsed), that does not respond to treatment (refractory), or that is growing, spreading, or getting worse (progressive) following prior chemoimmunotherapy. Iberdomide is a cereblon-modulating agent. It works by helping the immune system kill tumor cells. Chemoimmunotherapy is chemotherapy combined with immunotherapy. Chemotherapy drugs, such as cyclophosphamide and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with dinutuximab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Granulocyte-macrophage colony-stimulating factors (GM-CSF), such as sargramostim, may increase the production of blood cells and may help the immune system recover from the side effects of chemotherapy. Giving iberdomide with chemoimmunotherapy may be safe, tolerable, and/or effective in treating patients with relapsed, refractory, or progressive neuroblastoma following prior chemoimmunotherapy.

Key Dates

Start date
Jul 30, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
76 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 (iberdomide, CPM, Topo, DIN, GM-CSF)
    Patients receive iberdomide PO, via NG-tube, or via G-tube QD on days 1-14 or 1-21, cyclophosphamide IV over 15-30 minutes on days 1-5, topotecan IV over 30 minutes on days 1-5, dinutuximab IV over 10 hours on days 2-5, and sargramostim SC or IV over 2 hours starting on day 6 or 7 and continuing for a minimum of 7 doses until ANC is ≥ 1500/μL after the expected nadir or until day 21 of each cycle. Cycles repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo ECHO or MUGA, bone marrow aspiration and biopsy, CT or MRI, and 123I-MIBG scans or FDG-PET throughout the study. Patients also undergo blood sample collection on study.
  • Experimental: Phase 1 arm b (iberdomide, CPM, Topo, DIN, GM-CSF)
    Patients receive iberdomide PO, via NG-tube, or via G-tube QD on days 1-14 or 1-21, as determined in phase 1, cyclophosphamide IV over 15-30 minutes on days 1-5, topotecan IV over 30 minutes on days 1-5, dinutuximab IV over 10 hours on days 2-5, and sargramostim SC or IV over 2 hours starting on day 6 or 7 and continuing for a minimum of 7 doses until ANC is ≥ 1500/μL after the expected nadir or until day 21 of each cycle. Cycles repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo ECHO or MUGA, bone marrow aspiration and biopsy, CT or MRI, and 123I-MIBG scans or FDG-PET throughout the study. Patients also undergo blood sample collection on study.
  • Active Comparator: Phase 2 arm a (CPM, Topo, DIN, GM-CSF)
    Patients receive cyclophosphamide IV over 15-30 minutes on days 1-5, topotecan IV over 30 minutes on days 1-5, dinutuximab IV over 10 hours on days 2-5, and sargramostim SC or IV over 2 hours starting on day 6 or 7 and continuing for a minimum of 7 doses until ANC is ≥ 1500/μL after the expected nadir or until day 21 of each cycle. Cycles repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo ECHO or MUGA, bone marrow aspiration and biopsy, CT or MRI, and 123I-MIBG scans or FDG-PET throughout the study. Patients also undergo blood sample collection on study.

Primary Outcome Measure

Incidence of therapy-associated dose limiting toxicities (Phase 1) [ Time Frame: During cycle 1 (Cycle length = 28 days) ]

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