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ACTIVE NOT RECRUITING
NCT05139004
PHASE1

90Y-DOTA-anti-CD25 Basiliximab, Fludarabine, Melphalan, and Total Marrow and Lymphoid Irradiation for the Treatment of High-Risk Acute Leukemia or Myelodysplastic Syndrome

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

7

Start Date

2022-07-19

Completion Date

2027-06-13

Last Updated

2025-07-08

Healthy Volunteers

No

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo AHSCT

BIOLOGICAL

Basiliximab

Given IV

DRUG

Fludarabine Phosphate

Given IV

DRUG

Indium In 111-DOTA-Basiliximab

Given IV

DRUG

Melphalan

Given IV

BIOLOGICAL

Palifermin

Given IV

RADIATION

Total Lymphoid Irradiation

Undergo TMLI

RADIATION

Total Marrow Irradiation

Undergo TMLI

BIOLOGICAL

Yttrium Y 90 Basiliximab

Given IV

Locations (1)

City of Hope Medical Center

Duarte, California, United States