Basiliximab

Phase I Study of Escalating Doses of 90Y-DOTA-Anti-CD25 Monoclonal Antibody Added to the Conditioning Regimen of Fludarabine, Melphalan, and Organ Sparing Total Marrow and Lymphoid Irradiation (TMLI) as Conditioning for Allogeneic Hematopoietic Cell Transplantation in Patients With High-Risk Acute Leukemia or Myelodysplastic Syndrome

What's the purpose of the trial?

This phase I trial is to find out the best dose, possible benefits and/or side effects of 90Y-DOTA-anti-CD25 basiliximab given together with fludarabine, melphalan, and total marrow and lymphoid irradiation (TMLI) in treating patients with high-risk acute leukemia or myelodysplastic syndrome. 90Y-DOTA-anti-CD25 basiliximab is a monoclonal antibody, called basiliximab, linked to a radioactive agent called 90Y-DOTA. Basiliximab attaches to CD25 positive cancer cells in a targeted way and delivers 90Y-DOTA to kill them. Fludarabine and melphalan are common chemotherapy drugs used to prepare the bone marrow to receive transplanted cells. TMLI is a different type of targeted radiation therapy used to prepare the bone marrow to receive transplanted cells. Giving 90Y-DOTA-anti-CD25 basiliximab together with fludarabine, melphalan, and TMLI may help prepare the bone marrow to receive the transplanted cells for improved transplant outcomes in patients with acute leukemia or myelodysplastic syndrome.
Trial status

Accepting patients

Phase
Phase 1
Enrollment
12
Last Updated
4 weeks ago
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Experimental Treatments

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  • Basiliximab is a monoclonal antibody that is FDA approved for use in kidney transplant patients to help prevent rejection. It is being studied for use in several other different indications both by itself, and in combination with radioactive isotopes.
  • Fludarabine is a chemotherapy medication that may be used in the treatment of many different cancers.
  • Melphalan is a chemotherapy medication used in the treatment of different cancers.
  • Palifermin is a cytoprotectant that can treat and prevent swelling, irritation, sores, and ulcers in the mouth caused by cancer treatment.

Arms / Cohorts

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Accepting patients

90Y-basiliximab + Fludarabine + Melphalan + Total Marrow & Lymphoid Irradiation

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