Clinical Trial Detail

The purpose of this study is to learn more about the effects, good and bad, of stem-cell transplantation that uses umbilical cord blood as the stem-cell source. This study is for subjects who are 45 years of age or younger, and who do not have a suitably matched stem cell donor. Analysis of the effects of transplants helps us improve transplant outcomes in the future.

As part of the transplant process, participants will receive high doses of chemotherapy and radiation to treat their underlying disease. This chemotherapy and radiation treatment also kills the healthy blood stem cells that are already in the bone marrow. Participants will receive blood stem cells from the umbilical cord of a healthy donor to help recover the bone marrow.

Participants will be hospitalized for the transplant. Adult participants will be hospitalized in Seattle at the University of Washington Medical Center, and pediatric participants at the Children’s Hospital and Regional Medical Center. Once discharged from the hospital, care will be given at the Seattle Cancer Care Alliance (SCCA) outpatient clinic.

Participants will be discharged from the hospital when medically ready. It will be necessary to return for follow-up to the clinic frequently initially (1-3 times per week) and subsequently at specific dates as determined by the participant’s physician. Follow-up care after the transplantation (after about 3 months) will be according to the participant’s specific type of disease. Visits to the participant’s physician will likely be scheduled at 3 and 6 months, 1 year, and 2 years after the transplantation.

We may request that additional bone marrow or blood samples be drawn at various time points for up to 2 years after the transplant.

1. Participant is 45 years of age or younger (must be at least 6 months old).

2. Participant does not have a suitably matched, related or unrelated donor.

3. Participant has adequate heart, lung, kidney and liver function.

4. Participant has one of the following diseases:

a. Acute leukemia in complete remission (according to study guidelines);

b. Chronic myelogenous leukemia (except refractory blast crisis);

c. Advanced myelofibrosis;

d. Myelodysplastic syndrome with severe pancytopenia or complex cytogenetics;

e. Large-cell lymphoma (according to study guidelines);

f. Lymphoblastic, Burkitt’s and other high grade lymphomas;

g. Mantle-cell lymphoma, lymphoplasmacytic lymphoma, and prolymphocytic leukemia may be eligible after initial therapy;

h. Multiple myeloma (according to study guidelines).

Other eligibility criteria may apply.

1. Over 45 years of age (or under 6 months).

2. A suitably matched, related or unrelated donor is available.

3. Pregnancy or breastfeeding.

4. Evidence of HIV infection.

5. Uncontrolled viral or bacterial infection at the time of study enrollment.

6. Active or recent (prior 6 month) invasive fungal infection without ID consult and approval.

7. Presence of acute leukemia that has returned or is persistent.

8. Presence of large cell and high grade non-Hodgkins lymphoma that has not responded to previous treatment with chemotherapy (progressive disease after more than 2 salvage regimens).

9. If 18 years of age or younger, prior myeloablative transplant within the last 6 months.

10. If older than 18 years of age, prior myeloablative allotransplant or autologous transplant.

11. Extensive prior therapy including more than 12 months of alkylator therapy, or more than 6 months of alkylator therapy with extensive radiation.

Other exclusion criteria may apply.