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Complete title: A Pilot Study to Evaluate the Co-Infusion of Ex Vivo Expanded Umbilical Cord Blood Progenitors With an Unmanipulated Cord Blood Graft in Patients Undergoing Umbilical Cord Blood Transplantation for Hematologic Malignancies: A Multi-Center Trial Coordinated by the FHCRC
|Research Study Number||2044.00|
|Principal Investigator||Colleen Delaney, MD, MSc|
Research Study Description
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 Childrens 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 participants physician. Follow-up care after transplantation (after about three months) will be according to the participants 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.
Eligibility Criteria (must meet the following to participate in this study)
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, Hodgkins 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.
Exclusions (conditions that would prevent participation in this study)
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 Hodgkins lymphoma that is progressive on salvage therapy. Stable disease is acceptable to move forward provided it is non-bulky.
Other exclusion criteria may apply.
Acute Lymphoid Leukemia (ALL); Acute Myeloid Leukemia (AML); Acute Promyeloid Leukemia (APL); Bone Marrow and Hematopoietic Stem Cell Transplant (BMT and HSCT); Burkitt's Lymphoma; Chronic Myeloid Leukemia (CML); Hematologic Malignancies; Hodgkin's Lympho
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