Cord blood banks (CBB) are required to monitor clinical outcomes of cord blood unit (CBU) transplants performed by transplant centers (TC). Obtaining accurate and timely follow-up data on clinical outcomes from the TC can be very difficult. The National Marrow Donor Program (NMDP), by virtue of their comprehensive activities with member network centers, collects outcomes data on recipients transplanted with either cord blood or adult donor cells. NMDP member transplant centers are required to submit data at defined intervals as part of their participation agreement. A system is in place to monitor compliance that includes a due process procedure for non-compliant centers. Recipients sign an IRB-approved consent form for data submission to the NMDP. All submitted data are verified through system checks at time of data entry. Identified errors are subject to a formal error correction process. Transplant centers are audited on a four year cycle to assure the accuracy and integrity of the data provided. At any given time, >90% of NMDP centers are compliant with forms submission requirements. The data elements include information on the results of the thaw, infusion related reactions, preparative regimens, neutrophil and platelet engraftment, GVHD, relapse, survival and death. Member cord blood banks receive a quarterly report from the NMDP which includes comprehensive data on the individual recipients for which their CBUs were used. The data include recipient demographics, infused cell dose, degree of HLA match, engraftment, GVHD, relapse, survival, and cause of death. While outcomes data are reported quarterly to member banks, thaw data are reported and reviewed on a continuous basis. TNC recoveries that are low (<60%) or high (>100%) are reviewed by NMDP staff to detect problems with CBU potency that might be linked to a certain bank, shipping procedure or thawing protocol at a TC. Future directions include trending analysis reports and review with the NMDP Quality Standards subcommittee. The NMDP's process for reporting quality assurance data to member banks is a valuable service that is unlikely to be feasible in a single bank.
Various therapeutic options are available for patients with chronic myelogenous leukemia. Allogeneic stem cell transplantation, though often curative, is associated with high nonrelapse mortality and long-term morbidity, particularly when cells from unrelated donors are used. Many physicians and patients opt for a trial of interferon-alpha (IFN)-based therapy first, reserving transplantation for patients with inadequate response or intolerance to IFN. Data were analyzed on 740 patients receiving unrelated donor transplants for chronic myelogenous leukemia in first chronic phase provided by the International Bone Marrow Transplant Registry and the National Marrow Donor Program to see whether IFN pretreatment compromised transplantation outcome. A total of 489 (66%) had received IFN prior to transplantation; 251 (34%) had not. Disease characteristics in the 2 groups were similar at diagnosis but at the time of transplantation, hematologic parameters and weight were lower in IFN patients and the interval between diagnosis and transplantation was longer. After adjustment for baseline covariates, no effect of IFN exposure was found on overall survival, leukemia-free survival, nonrelapse mortality, engraftment, relapse, or acute or chronic graft-versus-host disease. Evaluation of effects based on duration of therapy and time off IFN prior to transplantation was limited by missing data and confounding with IFN intolerance and disease responsiveness. In conclusion, no evidence was found for an independent adverse effect of IFN pretreatment on the outcome of subsequent unrelated donor transplantation.