Reduced Intensity Double Umbilical Cord Blood Transplantation

Status:	Completed
Conditions:	Blood Cancer, Lymphoma, Hematology
Therapuetic Areas:	Hematology, Oncology
Healthy:	No
Age Range:	18 - 70
Updated:	1/25/2019
Start Date:	December 2011
End Date:	June 2017

A Phase II Study of Reduced Intensity Double Umbilical Cord Blood Transplantation Using Fludarabine, Melphalan, and Low Dose Total Body Radiation

This trial will use two cord blood units for transplantation using a reduced intensity
regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord blood
units (double cord blood) are being used, as the numbers of blood cells in one unit are too
few to allow successful growth of these cells.

Because the risk of infection, particularly virus infection, is high after double cord blood
transplant, this study seeks to reduce the rise of virus infection by using a reduced
intensity regimen without a medicine called antithymocyte globulin (ATG), as used in prior
cord blood transplants. Subjects will receive two chemotherapy drugs, melphalan and
fludarabine, and low dose of total body radiation (one treatment) instead of the ATG. The
number of patients with virus infections in this study will be compared to our prior
experience using the ATG.

Subjects will receive their transplants as in-patients.

- IV-Catheter

- one or two IV catheters will be placed on the day of hospital admission

- Conditioning

- Fludarabine IV six days before transplant (days -7, -6, -5. -4, -3, -2)

- Melphalan IV (day -1)

- Total body radiation on day 0 (same day as transplant)

- Immunosuppressive Therapy

- Tacrolimus and sirolimus beginning day -3, daily for 6-9 months post-transplant.
Given IV as in-patient, orally as out-patient

- Infusion of Cord Blood units

- 2 cord blood units IV on Day 0 Routine post-transplant supportive care will be
provided

Inclusion Criteria:

- Hematologic malignancy for whom allogeneic stem cell transplantation is deemed
clinically appropriate

- Appropriate candidate for reduced intensity regimen, according to the treating
physician

- Lack of 6/6/ or 5/6 HLA-matched related, 8/8/ HLA-matched unrelated donor, or
unrelated donor not available with a time frame necessary to perform a potentially
curative stem cell transplant

- Able to comply with the requirements for care after allogeneic stem cell
transplantation

Exclusion Criteria:

- Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular
dysfunction

- Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic
restrictive lung disease

- Renal disease

- Hepatic disease

- Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other
neuropsychiatric abnormalities believed to preclude transplantation

- HIV-positive

- Uncontrolled infection

- Pregnant or breast-feeding

We found this trial at

sites

Dana-Farber Cancer Institute

450 Brookline Ave
Boston, Massachusetts 2215

617-632-3000