Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases

StatusRecruiting

PhasePhase 2

SponsorFred Hutchinson Cancer Center

Started2024-07-23

View on ClinicalTrials.gov ↗

Amendment history

2026-07-20

3 amendments v12-v14

3 re-verifications since 2025-07-15, no change to tracked fields

2025-01-29

Study Status, Study Description, Conditions, Arms and Interventions v11

Study description+46 characters

[...] ated on study. Patients also undergo blood sample collection throughout the study and bone marrow aspirate during screening and on study. ARM [...] ated on study. Patients also undergo blood sample collection throughout the study and bone marrow aspirate during screening and on study. ~~Patients~~All patients receive GVHD prophylaxis comprising cyclosporine IV over 1 [...]

2024-08-21

Study Status v10

Start dateestimated 2024-09-01→confirmed 2024-07-23

2024-08-01

Study Status v9

Primary completion date2024-10-31→2031-10-31

Completion date2025-10-31→2032-10-31

Start date2024-08-08→2024-09-01

2024-07-08

Study Status v8

Start date2024-07-06→2024-08-08

Show 7 earlier versions

2024-06-06

Study Status v7

Start date2024-06-03→2024-07-06

2024-05-03

Study Identification, Study Status v6

Start date2024-05-03→2024-06-03

2024-04-03

Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v5

Trial statusNot Yet Recruiting→Recruiting

Start date2024-05-15→2024-05-03

Study sitesdetails revised at 1 of 1 site

2024-03-20

Study Status v4

Start date2024-03-15→2024-05-15

2024-02-15

Study Status v3

Start date2024-02-15→2024-03-15

2024-01-08

Study Status, Conditions, Arms and Interventions, Eligibility v2

Start date2024-02-06→2024-02-15

Eligibility criteria-42 characters

[...] ion (CR1), complete second remission (CR2) or greater (CR2+), must have < 5% marrow blasts at the time of transplant. Pat [...] stigator (PI). For patients > 18 years old, Karnofsky score ~~equal or greater than~~≥ 70%. For patients =< 18 years old, Lansky score ~~equal to or greater than~~≥ 50%. Calculated creatinine clearance > 70 ml/min. Bilirubin [...]

2023-12-06

Study Status v1

Start date2024-01-01→2024-02-06

2023-08-22

Original filing

Fred Hutchinson Cancer Center

128 trials monitored

See 13 trials at risk

Leukemia

2,553 trials monitored

See 134 trials at risk

Non-Hodgkin Lymphoma

1,512 trials monitored

See 79 trials at risk

Acute Myeloid Leukemia (AML)

1,196 trials monitored

See 63 trials at risk

and 3 more diseases

This phase II trial studies how well giving an umbilical cord blood transplant together with cyclophosphamide, fludarabine, and total-body irradiation (TBI) works in treating patients with hematologic diseases. Giving chemotherapy, such as cyclophosphamide, fludarabine and thiotepa, and TBI before a donor cord blood transplant (CBT) helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening in patients with high-risk hematologic diseases.

Trial Details

NCT Number	NCT06013423
Lead Sponsor	Fred Hutchinson Cancer Center Collaborators: National Cord Blood Network
Conditions	Acute Leukemia of Ambiguous Lineage, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm, Hematopoietic and Lymphatic System Neoplasm, Mixed Phenotype Acute Leukemia, Myelodysplastic Syndrome, Myeloproliferative Neoplasm +2 more
Enrollment	54 participants
Start Date	2024-07-23
Primary Completion	2031-10-31 (estimated)
Study Completion	2032-10-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-22