Intra-Osseous Co-Transplant of UCB and hMSC

Summary

This clinical trial studies intra-osseous donor umbilical cord blood and mesenchymal stromal cell co-transplant in treating patients with hematologic malignancies. Giving low doses of chemotherapy and total-body irradiation before a co-transplant of donor umbilical cord blood and mesenchymal stromal cells into the bone (intra-osseous) helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil at the time of transplant may stop this from happening.

Conditions

• Acute Lymphoblastic Leukemia
• Acute Myelogenous Leukemia
• Myelodysplastic Syndromes
• Myelofibrosis
• Relapsed Non-Hodgkin Lymphoma
• Refractory Non-Hodgkin Lymphoma
• Hodgkin Lymphoma
• Refractory Hodgkin Lymphoma
• Relapsed Chronic Lymphocytic Leukemia
• Refractory Chronic Lymphocytic Leukemia
• Lymphoid Malignancies
• Chronic Myelogenous Leukemia

Interventions

DRUG

cyclophosphamide

All patients will receive a single IV dose of 50 mg/kg of cyclophosphamide on day -6

DRUG

fludarabine phosphate

Given by IV during prep at 40mg/m2 for 5 days

RADIATION

total-body irradiation

Undergo single fraction of reduced intensity conditioning (RIC) regimen of 200 cGy TBI without shielding on day -1

DRUG

cyclosporine

Initiated in patients on the day -5. Cyclosporine will be administered orally or intravenously at 2 mg/kg/dose every 12 hours for 2-hour period. Cyclosporine will continue until day +100

DRUG

mycophenolate mofetil

Given at 1g intravenously or orally twice daily from day -5 to +100, or as clinically indicated.

PROCEDURE

umbilical cord blood transplantation

Following RIC, on day T+0, dimethylsulphoxide will be removed from the cord blood cells and given as transplant.

PROCEDURE

mesenchymal stem cell transplantation

The total dosage of hMSC will be 2x10\^6cells/kg (+/-20%).

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Case Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Leland Metheny, MD · Case Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-07-22

Primary Completion

2019-12-19

Completion

2020-02-07

FDA Drug

Yes

Countries

• United States

Study Locations