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

Summary

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.

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
• Non-Hodgkin Lymphoma
• Chronic Myeloid Leukemia, BCR-ABL1 Positive

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspirate

Undergo bone marrow aspirate

DRUG

Cyclophosphamide

Receive IV

DRUG

Cyclosporine

Receive IV or PO

PROCEDURE

Diagnostic Imaging

Undergo diagnostic imaging

PROCEDURE

Echocardiography

Undergo ECHO

DRUG

Fludarabine Phosphate

Receive IV

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

DRUG

Mycophenolate Mofetil

Receive IV

OTHER

Survey Administration

Ancillary studies

DRUG

Thiotepa

Receive IV

RADIATION

Total-Body Irradiation

Undergo high-dose or middle-intensity TBI

PROCEDURE

Umbilical Cord Blood Transplantation

Undergo UCBT

Sponsors & Collaborators

• National Cord Blood Network

  collaborator UNKNOWN

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Ann Dahlberg · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

6 Months

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-23

Primary Completion

2031-10-31

Completion

2032-10-31

FDA Drug

Yes

Countries

• United States

Study Locations