Clinical Trial Detail

For some patients with hematologic malignancies, the best chance for survival or cure may be a bone-marrow transplant, yet many of these patients cannot find a suitable blood-stem-cell donor (either a "matched" relative or an unrelated donor). This is particularly true for minority patients and patients of mixed ethnicity. For those patients who do not have a suitable donor, umbilical cord blood can be used as an alternative source of blood stem cells for bone-marrow transplant. However, the use of cord blood is relatively new and is still considered to be an alternative type of transplant. Furthermore, the use of cord blood for bone-marrow transplant is limited in adults and larger children due to the low number of cells available in a single cord blood unit.

The purpose of this study is to evaluate the safety of giving study participants umbilical-cord-blood cells that have been grown (expanded) in the laboratory to increase the number of cells available for the transplant. In the case of this study, two separate, unrelated umbilical-cord-blood units are used - one unit that has been expanded in the lab to increase the number of cells, and one that has not been expanded or manipulated in any way. This second, unmanipulated unit of cord-blood cells is given as a measure of safety, to ensure that the participant will receive adequate numbers of cells. Giving the expanded cells to study participants is experimental, and the safety of this treatment has not yet been determined.

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.

The participant 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 transplantation (after about three months) will be according to the participant’s specific type of disease. Physical exams and tests will likely occur 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 5 years after the transplant.

1. Participant is between the ages of 6 months and 45 years of age.

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 (high risk CR1 or subsequent CR);

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

c. Myelodysplastic syndrome (MDS) with severe pancytopenia or complex cytogenetics;

d. Large-cell lymphoma, Hodgkin’s lymphoma, multiple myeloma, chronic lymphocytic leukemia/small lymphocytic lymphoma, marginal zone b-cell lymphoma, follicular lymphoma, lymphoplasmacytic lymphoma, mantle-cell lymphoma, and prolymphocytic leukemia may be eligible according to study guidelines.

e. Refractory leukemia or MDS in aplasia after chemotherapy or radiolabeled antibody.

Other eligibility criteria may apply.

1. A suitable donor is available (5-6/6 HLA-A, B, DRB1 matched sibling donor).

2. Pregnancy or breastfeeding.

3. Evidence of HIV infection.

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

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

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

7. Presence of chronic myelogenous leukemia (CML) in refractory blast crisis.

8. Presence of large-cell lymphoma, mantle-cell lymphoma and Hodgkin’s lymphoma that is progressive on salvage therapy. Stable disease is acceptable to move forward provided it is non-bulky.

Other exclusion criteria may apply.