Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease

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 disease. Giving chemotherapy, such as cyclophosphamide and fludarabine, and TBI before a donor umbilical cord blood transplant 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.

Conditions

• Acute Biphenotypic Leukemia
• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Burkitt Lymphoma
• Chronic Lymphocytic Leukemia
• Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Follicular Lymphoma
• Lymphoblastic Lymphoma
• Lymphoplasmacytic Lymphoma
• Mantle Cell Lymphoma
• Marginal Zone Lymphoma
• Myelodysplastic Syndrome
• Myelofibrosis
• Non-Hodgkin Lymphoma
• Plasma Cell Myeloma
• Prolymphocytic Leukemia
• Refractory Anemia
• Small Lymphocytic Lymphoma

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Cyclosporine

Given IV and PO

PROCEDURE

Double-Unit Umbilical Cord Blood Transplantation

Undergo double-unit UCBT

DRUG

Fludarabine

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Mycophenolate Mofetil

Given IV and PO

RADIATION

Total-Body Irradiation

Undergo high-dose or moderate-intensity TBI

PROCEDURE

Umbilical Cord Blood Transplantation

Undergo UCBT

DRUG

Thiotepa

Given IV

Sponsors & Collaborators

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

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

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-11-18

Primary Completion

2023-12-22

Completion

2024-12-19

Countries

• United States

Study Locations