Who is sponsoring NCT05139004?

NCT05139004 is sponsored by City of Hope Medical Center.

What drugs are being tested in NCT05139004?

Interventions in NCT05139004: Allogeneic Hematopoietic Stem Cell Transplantation, Basiliximab, Fludarabine Phosphate, Indium In 111-DOTA-Basiliximab, Melphalan, Palifermin, Total Lymphoid Irradiation, Total Marrow Irradiation, Yttrium Y 90 Basiliximab.

What condition does NCT05139004 study?

NCT05139004 studies Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome, Secondary Acute Myeloid Leukemia.

Is NCT05139004 still recruiting?

NCT05139004 is currently active, enrolled. Last updated 8 July 2025.

Last reviewed 2025-07-08 · How we verify

NCT05139004

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Phase 1 Last updated 8 July 2025

What this trial tests

Phase 1 trial testing Allogeneic Hematopoietic Stem Cell Transplantation in Acute Lymphoblastic Leukemia in 7 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

19 July 2022

Primary endpoint
13 June 2027

13 June 2027

Quick facts

Lead sponsor	City of Hope Medical Center
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	19 July 2022
Primary completion	13 June 2027
Estimated completion	13 June 2027
Sites	1 location across United States

Drugs / interventions tested

Allogeneic Hematopoietic Stem Cell Transplantation
Basiliximab (BASILIXIMAB) — full drug profile →
Fludarabine Phosphate (FLUDARABINE PHOSPHATE) — full drug profile →
Indium In 111-DOTA-Basiliximab — full drug profile →
Melphalan
Palifermin (PALIFERMIN) — full drug profile →
Total Lymphoid Irradiation
Total Marrow Irradiation
Yttrium Y 90 Basiliximab

Conditions studied

Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →
Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
Myelodysplastic Syndrome — all drugs for Myelodysplastic Syndrome →
Secondary Acute Myeloid Leukemia — all drugs for Secondary Acute Myeloid Leukemia →

Sponsor

City of Hope Medical Center

Who can join

60 and older, any sex, with Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Regulation of hematopoietic and leukemia stem cells by regulatory T cells.
Riether C. · · 2022 · cited 15× · PMID 36405718 · DOI 10.3389/fimmu.2022.1049301
RNA-sequencing based first choice of treatment and determination of risk in multiple myeloma.
Emde-Rajaratnam M, Beck S, Benes V, Salwender H, et al · · 2023 · cited 10× · PMID 38035078 · DOI 10.3389/fimmu.2023.1286700
Maintain Efficacy and Spare Toxicity: Traditional and New Radiation-Based Conditioning Regimens in Hematopoietic Stem Cell Transplantation.
Dogliotti I, Levis M, Martin A, Bartoncini S, et al · · 2024 · cited 6× · PMID 38473227 · DOI 10.3390/cancers16050865
Monoclonal Antibodies Against Myeloid Leukemia Cells: Current Knowledge and Future Directions.
Damiani D, Tiribelli M. · · 2025 · cited 2× · PMID 40429716 · DOI 10.3390/ijms26104571

Verify or expand the search:

Other trials of Allogeneic Hematopoietic Stem Cell Transplantation

Trials testing the same drug.

NCT06954987 — Venetoclax or Placebo in Combination With Reduced-Intensity Conditioning Hematopoietic Cell (Bone Marrow/Blood Stem Cell · Phase 2 · not yet recruiting
NCT04579523 — ²¹¹At-OKT10-B10 and Fludarabine Alone or in Combination With Cyclophosphamide and Low-Dose TBI Before Donor Stem Cell Tr · Phase 1 · not yet recruiting
NCT07349771 — Axatilimab Plus Standard of Care Therapy for the Prevention of Graft Versus Host Disease Following Allogeneic Hematopoie · Phase 2 · not yet recruiting
NCT07500753 — A Single-arm, Prospective Study of a Clad-LABU Conditioning Regimen in HSCT for R/R MDS/AML in Elderly Patients · NA · recruiting
NCT07228624 — Ruxolitinib Before, During and After Hematopoietic Cell Transplant in Older Patients With Myelofibrosis and Myelodysplas · Phase 2 · recruiting

Other recruiting trials for Acute Lymphoblastic Leukemia

Currently open trials in the same condition.

NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
NCT05621291 — A Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-cell Recovery to Guide Management Follo · NA · recruiting
NCT07356154 — A Study of Revumenib and Mezigdomide in People With Leukemia · Phase 1, PHASE2 · recruiting
NCT07479927 — Telematic Cognitive Training and Mindfulness in Pediatric Patients After CAR-T Cell Therapy, Single Hematopoietic Alloge · NA · recruiting

Other City of Hope Medical Center trials

Trials by the same sponsor.

NCT07365306 — Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant · Phase 2 · not yet recruiting
NCT07218692 — RP2 and Tivozanib for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy · Phase 2 · not yet recruiting
NCT07363408 — Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment · Phase 1 · not yet recruiting
NCT07226102 — Virtual Mental Health Intervention to Address Fear of Progression for Women With High Risk or Stage III-IV Gynecologic o · NA · withdrawn
NCT07225855 — Geriatric Assessment and Management for Older Adults Undergoing Chemotherapy and Radiation Therapy for Head and Neck Can · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05139004 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by City of Hope Medical Center
Last refreshed: 8 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05139004.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing