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NCT05139004 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by City of Hope Medical Center.

Active
Registry status
Phase 1
Development phase
7
Enrollment target
1
Study location

NCT05139004 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 7 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05139004, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is active but no longer recruiting, sponsored by City of Hope Medical Center.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
7 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Acute Myeloid Leukemia Myelodysplastic Syndrome Acute Lymphoblastic Leukemia Secondary Acute Myeloid Leukemia

Interventions

  • DRUG Melphalan
  • DRUG Fludarabine Phosphate
  • BIOLOGICAL Basiliximab
  • PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
  • DRUG Indium In 111-DOTA-Basiliximab

Study Locations (1)

California

  • City of Hope Medical Center - Duarte

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2022-07-19
Est. Completion 2027-06-13
Phase Phase 1

Sponsor

City of Hope Medical Center

582 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05139004

The ClinicalTrials.gov registry entry for NCT05139004 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (94% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Melphalan is the first listed.

NCT05139004 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT05139004 about?

NCT05139004 is a clinical study titled "90Y-DOTA-anti-CD25 Basiliximab, Fludarabine, Melphalan, and Total Marrow and Lymphoid Irradiation for the Treatment of High-Risk Acute Leukemia or Myelodysplastic Syndrome". 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-DO...

What is the current status of trial NCT05139004?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2022-07-19. Estimated completion is 2027-06-13.

What conditions does trial NCT05139004 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, Secondary Acute Myeloid Leukemia.

What interventions are being tested in trial NCT05139004?

The interventions under investigation include: Melphalan (DRUG), Fludarabine Phosphate (DRUG), Basiliximab (BIOLOGICAL), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), Indium In 111-DOTA-Basiliximab (DRUG).

Who is sponsoring clinical trial NCT05139004?

This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05139004 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.