ALBERT

Description: Abstract 3360 Poster Board III-248 Purpose Richter's syndrome (RS) occurs in 2-8% of patients with chronic lymphocytic leukaemia (CLL). Clinical outcome has been generally poor after multiagent chemotherapy with median survival of less than 1 year. The aim of this retrospective study was to evaluate whether an autologous (AutoSCT) or an allogeneic stem cell transplantation (alloSCT) offers survival benefit. There are scant data addressing this issue. Patients and Methods As patients with RS are not identified separately in the current EBMT database a request was sent to all EBMT centres known to have performed SCT in patients with CLL, high-grade lymphoma or Hodgkin's lymphoma asking for RS transplants. Inclusion criteria included a diagnosis of RS prior to SCT, age 〉 18 years, and SCT performed 1997-2007. Centers who reported RS transplants received a questionnaire to collect detailed information on disease and transplant characteristics and outcome results. Data were analyzed by descriptive statistics and survival comparisons using log rank testing and Cox modelling. Fifty nine transplants for RS were reported by 25 centres, which is the largest cohort described. Thirty nine patients (25 (64%) male) underwent AutoSCT (of whom 8 underwent a subsequent alloSCT). The median age was 56 years (range, 30-68 years) and 44% (n=17) of transplants were performed after 2003, with a TBI-containing regimen used in 5 patients. A minority (36% of cases with data known) of patients had received ≥3 lines of prior therapy. The majority of transplants (n=32; 84%) were performed within a year of diagnosis of RS, and 91% of patients (with data known) were in CR/PR at time of transplant. With a median follow-up of 27 months, 15/39 (39%) patients were alive and 13 patients were disease-free, 21 (39%) had relapsed (19 died from relapse) and 5 (13%) died of treatment-related complications after ASCT. OS was 54% and 25% at 3 and 5 yrs respectively. Relapse incidence of 49%, NRM of 14% and PFS of 37% was observed at 3 yrs. Twenty patients (12 (60%) male) underwent alloSCT from a matched sibling donor (n=10), VUD (n=8) or an alternative donor (n=2) with PBSC used in 90% of cases. The median age was 57 years (range, 42-70 years) and 70% (n=14) of transplants were performed after 2003. A majority (80%) of patients underwent alloSCT within 1 year of diagnosis of RS and had received ≥3 lines of prior therapy (71% of known cases). Conditioning was reduced-intensity (RIC) in 14 cases and myeloablative in 6 patients, with TBI used for 4 patients and T-cell depletion strategies in 13. At time of alloSCT 14 patients were in CR/PR and 5 had progressive disease (missing data in 1 case). With a median follow-up of 15 months (range, 3-94 months) 11/20 (55%) patients were alive after alloSCT, of whom 7 were in CR/PR. Overall survival (OS) was 51% and 41% at three years and 5 years respectively. Conditioning (myeloablative vs RI-conditioning; P = 0.14) and source of donor (HLA-id sib vs VUD; P = 0.97) did not statistically influence outcome. OS was not statistically affected by the variables: prior lines of therapy 〈 3 or ≥3 lines (P = 0.72), CMV serostatus recipient/donor (P = 0.23), use of T-cell depletion (P = 0.88) or disease status at time of transplant. The 3 yr OS for patients transplanted in CR/PR was 51% compared to 27% for those transplanted with progressive disease (P = 0.18). Outcome was superior for patients 〈 60 yrs at alloSCT (p=0.04). Relapse incidence of 38%, NRM of 23% and PFS of 39% was observed at 3 yrs. Acute GVHD grade II to IV occurred in 30% of patients and there were no cases of extensive chronic GVHD within reported cases. Conclusion This is the largest study that has assessed the outcome after transplantation of patients with RS. In summary patients with RS who are chemosensitive to induction therapies may benefit from consolidation with transplantation strategies. Disclosures: No relevant conflicts of interest to declare.

Description: Abstract 3811 Poster Board III-747 Background The European LeukemiaNet has initiated a prospective, noninterventional registration study on newly diagnosed MDS patients with IPSS low and intermediate-1 risk in eleven participating European countries. The main objectives are to describe demographics and to collect data on clinical characteristics, disease management and relevant outcomes. Patients and Methods The registry started accruing patients in April 2008. Until now 478 patients have been registered through a web-based reporting system. This report describes the demographic data of the first 400 registered patients with a median follow up of 177 days. Results The median age of the patients was 74 years. RAEB-1 was the WHO-diagnosis in 13% of the patients while the remaining patients had 〈 5% marrow blasts (RA: 81; RARS: 84; RCMD: 114; RCMD-RS: 26, MDS-U: 16; del(5q): 27). The majority of patients were males 250/400 except within WHO del(5q) which showed a female preponderance 21/27. Cytogenetic data were available in 93% of the patients and 77% had good risk cytogenetic characteristics. IPPS score was 0 in 50% of the patients, 0.5 in 28% patients and 1 point in 15% of the patients. The Karnofsky performance score was reported in 85% of the patients. The Karnofsky index was related to age (p

Description: Alloreactive donor Natural Killer (NK) cells, displaying a KIR-ligand mismatch with the recipient play a pivotal role in graft-versus-leukemia (GVL) reactivity without significant graft-versus-host disease (GVHD) following haploidentical stem cell transplantation. Therefore, infusions of haploidentical NK cells are suggested to become an attractive approach for cancer immunotherapy. So far, difficulties in isolation and expansion of peripheral NK cells resulted in only limited data about safety and clinical efficacy of purified NK cell infusions. Therefore, we have developed a novel culture system without the use of feeder cells for the ex vivo generation of NK cells from CD34+ hematopoietic progenitor cells (HPCs) isolated from cord blood (CB) or bone marrow (BM). It is based on a two-step procedure using an expansion and a differentiation step. The NK cell generation system uses mainly cytokines such as SCF, TPO, Flt3-L, IL-2, IL-7 and IL-15 and specific modified glycosaminoglycans (GAGs) to direct and control the two phases. The developmental phase and the final NK cell product is controlled and characterized by immunophenotyping using multi-colour flow cytometry and CFSE-based cytotoxicity assays against various tumor cells. Our system generates a homogeneous final cell product of CD56+/CD3- cells with a purity of 〉99%. A total cell expansion of more than 5×10^4 fold allows to generate 5×10^10 NK cells from 1×10^6 CB CD34+ stem and progenitor cells within 4–5 weeks of culture. For BM cells an expansion rate of more than 1×10^4 fold was detected after a 5–6 week cell culture period. During the two week expansion phase step,we expand UCB CD34+ cells more than 100 fold. Phenotypic analysis showed a decrease of stem cell-specific antigens such as CD34 and CD117 during the first three weeks, whereas antigens specific for NK cell progenitors and mature NK cells such as CD56, CD94 and CD161 are up-regulated after initiating differentiation at day 14. Furthermore, distinct cell populations can be detected reflecting NK cell developmental stages in vitro. Effective differentiation of the expanded progenitor cells into mature NK cells is characterized by the expression of NK cell-specific antigens including CD56, CD94, NKG2A, NKG2D and NCRs as well as homing receptors such as CD62L, CXCR4 and CCR7. The final NK cell product shows high expression levels of inhibitory and activating receptors as well the intrinsic capability to express KIR, which is detected by flow cytometry after 6–7 weeks of culture. Cytotoxicity assays demonstrated robust lysis of more than 90% against AML as well as melanoma tumor cell lines. This system, with its huge expansion potential to generate highly activated NK cells with homing capability, is the basis for a first clinical trial in 2009, to infuse haploidentical NK cells generated from CD34+ cells in poor-risk AML patients. The use of our defined culture conditions enables new prospects in NK cell research, regarding NK cell development and NK cell maturation, as well as new aspects for the clinical use of NK cell products derived from HPCs.

Description: Abstract 2008 We have previously reported a dismal outcome for patients with Plasma Cell Leukaemia (PCL) undergoing autologous transplantation, although such patients represent the younger and fittest with this condition and show superior survival to reports of non transplant patients. In this study we report two analyses of 85 eligible patients with PCL who received an allogeneic transplantation (Allo) between 1984 and 2009 and 411 patients receiving autologous transplantation (Auto) in the same period and a further comparison with 850 (Allo) myeloma MM.The first analysis was restricted to the years 1998 to 2009 allowing the identification of a large Myeloablative (MAC) population (n=45) and a smaller reduced intensity (n=17) conditioning (RIC) group. On account of the number of comparisons in the study and the size of the sub populations, only statistically highly significant differences are reported; less significantly powerful differences are viewed as a trend. Patients treated with MAC and RIC were essentially similar although significantly younger (45.9 and 52.9 yrs respectively) than the Auto patients (55.9 yrs) at the time of diagnosis, with similar differences at the time of transplant. RIC patients had a longer time (10.2 months) to transplant than the MAC (6.0m) and Auto (5.8m) groups. No difference was seen in rates of engraftment, acute or chronic graft versus host disease. MAC patients had a higher Complete Response (CR) than Auto. Progression Free Survival (PFS) at 12 and 60 months respectively (with Confidence Intervals) was as follows: Auto; 0.51 (0.45 – 0.57) and 0.10 (0.06 – 0.15), MAC; 0.39 (0.26 – 0.57) and 0.19 (0.09 – 0.39), RIC; 0.43 (0.23 – 0.80) and 0.11 (0.02 – 0.67) with the MAC and RIC curves possibly crossing the Auto curve between 2 and 4 years. These differences are due to highly significant differences in Non Relapse Mortality (Auto better) and Progression (Auto worse) This translates into Overall Survival (OS) at similar times (12 and 60 months) to PFS as follows: Auto; 0.73 (0.68 – 0.78) and 0.25 (0.19 – 0.33), MAC; 0.46 (0.33 – 0.65) and 0.27 (0.16 – 0.47), RIC; 0.59 (0.38 – 0.91) and 0.19 (0.04 – 0.93). The differences between MAC and RIC were not statistically significant. It was noted that whereas Auto patients continue to relapse with time there is a (small) plateau of survivors in both MAC and RIC. These findings are confirmed in the larger non selected analysis of all Auto and Allo patients Although age is seen as a strong prognostic factor favouring the Allo patients appropriate adjustment was made in the analysis. In the comparison of Allo in PCL v. MM the PFS and OS for PCL was inferior to MM: Data at 48 months for PFS and OS respectively: MM 0.22 (0.19 – 0.26) and 0.44 (0.40 – 0.48), PCL 0.20 (0.10 – 0.41) and 0.32 (0.19 – 0.53). In all three analyses the PCL Allo group shows a clear plateau at about 0.2 (20%) similar that seen in a number of recent studies of Allo transplantation in MM, but at a lower level. This contrasts with the ongoing attrition of patients experiencing progression in Auto transplantation. This study presents the first major analysis of Allo transplantation in PCL, confirms the poor prognosis with all types of transplant therapy while indicating it remains the best option for patients with PCL. Further improvements in the management of NRM can improve the outcome for these patients. Disclosures: No relevant conflicts of interest to declare.

Description: Abstract 3363 Poster Board III-251 The introduction of reduced-intensity conditioning regimens and the reduction of therapy-related complications have increased the upper age limit of the recipient and encouraging results of allogeneic stem cell transplantation in MDS-patients have been reported up to the age of 70 years. However, whether elderly patients with MDS should undergo allogeneic stem cell transplantation is a matter of debate. We used a multi-state approach to compare the outcome in elderly advanced MDS patients (aged 55 – 69 years) with RAEB or RAEB-t who received only best supportive care and were reported to the Düsseldorf registry (n = 137), to those who received allogeneic stem cell transplantation and were reported to the European Group for Blood and Marrow Transplantation (EBMT) (n = 246). A simple direct comparison is biased by non-observable patients who die before transplant. We used left-truncation and modelling of transition probabilities to obtain estimates of survival after diagnosis; moreover scenario analyses were performed to quantify sensitivity for untestable assumptions and to estimate survival for various strategies depending on the time between diagnosis and transplant. In the non-transplant cohort, diagnosis was RAEB in 100 (73%) and RAEB-t in 37 patients (27%). The median age of the 83 male and 54 female patients was 62 years. Cytogenetic data were available in 79 patients and reported to be abnormal in 60 %. In the transplant cohort 168 were male and 78 female. Disease status at diagnosis was RAEB (70%) and RAEB-t (30%). At time of transplantation, diagnosis was RAEB (54%), RAEB-t (34%) and transformed secondary acute leukemia (12%). Transplantation from HLA-identical sibling (n = 175) or unrelated donor (n = 71) was performed after standard myeloablative (n = 76) or reduced-intensity conditioning (n = 170). Cytogenetic data were available in 88 patients and reported to be abnormal in 60 %. The median follow-up of the non-transplant cohort was 21 and of the transplant cohort measured from date of transplant was 64 months. Median time between date of diagnosis and date of transplant was 7 months. The cumulative incidence of non-relapse mortality of the transplant cohort at 1 year and 3 years was 15% and 31%, respectively. The cumulative incidence of relapse was 14% and 29% at the same time points. Univariately, after accounting for left truncation and modelling of the death rate before transplant, the hazard ratio for survival is estimated as 0.72 in favour of transplant (95 % CI: 0.53 – 0.99; p = 0.04). After adjustment for year of diagnosis, the hazard ratio remained unchanged (the year of diagnosis was neither a confounder nor it showed interaction). In a multivariate analysis, adjusting for age at diagnosis, sub-diagnosis (RAEB vs. RAEB-t), cytogenetics (abnormal vs. normal), the hazard ratio for transplantation versus no-transplantation: 0.77 (95 % CI: 0.44 – 0.99; p = 0.1) while the other hazard ratio's were: 1.4 for “age 〉 60” (95 % CI: 1.10 – 1.70; p = 0.02); 1.20 for “RAEB-t” (95 % CI: 0.92 – 1.48; p = 0.2) and 1.46 for “abnormal cytogenetics” (95 % CI: 1.16 – 1.76; p = 0.01). Despite of an estimated benefit of allogeneic SCT in comparison to best supportive care in elderly MDS patients with RAEB or RAEB-t, this conclusion evidently relies on several statistical assumptions, notably about the selection mechanism among patients scheduled for transplant but never reaching that treatment. Only a prospective trial comparing hypomethylating agents with a reduced-intensity transplant approach according to donor availability is capable of answering this question appropriately but our analysis may provide sufficient indication that such a randomization is both needed and ethically justified. Disclosures: No relevant conflicts of interest to declare.

Description: Abstract 1198 Poster Board I-220 Background: Unrelated cord blood transplantation is an alternative option to treat patients with high risk hematologic malignancies in the absence of an HLA identical donor. Results of UCBT in patients with MDS or secondary leukaemia (sAML) have been scarcely published. Method: We performed a survey to identify predictors of outcomes in a large cohort of 108 adults with MDS or sAML reported to Eurocord-Promise data bases (62 centres in 17 countries in Europe) and transplanted with an UCBT from 1998 to 2007. Sixty-seven patients were transplanted for sAML (secondary to MDS in 42 cases) and 41 for MDS. Worst status before UCBT for MDS was RA in 4, RAEB1 in 10, RAEB2 in 14, CMML or RAEBt in 9, unclassified in 4 patients. IPSS classification at transplantation was low, intermediate 1, intermediate 2, high or missing in 8, 12, 7, 6 and 8 patients, respectively. For patients with sAML, 48% were transplanted in CR1 at UCBT. Median age at UCBT was 43 years (from 18 to 72 years). Median time from diagnosis to UCBT was 10 months. Transplant characteristics: 77 patients received a single and 31 a double UCBT. UCB grafts had ≥ 2/6 HLA mismatched in 60 % of cases. Myeloablative conditioning regimen (MAC) was given to 57 patients whereas 51 patients received a reduced intensity conditioning regimen (RIC). GVHD prophylaxis consisted in CSA+MMF in 52, CSA+steroids in 43 and other combinations in 13 patients. Median number of collected nucleated cells was 3.4 for single and 4.6 × 107/kg for double UCBT. Median follow-up was 25 months. Results: cumulative incidence (CI) of neutrophil recovery at day 60 was 82±4% with a median time to achieve more than 500 ANC/mm3 of 23 days. Neutrophil recovery was independently associated with number of CD34+ cells/kg (〉 1.1 × 105, Hazard Ratio (HR), 1.79; P= .02) and advanced disease status (intermediate 2 or high MDS and sAML not in CR; HR, 1.92; P= .007). CI of grade II-IV acute GVHD at day 100 and chronic GVHD at 2 years were 26±4% (II n=18, III n=6, IV n =6) and 42%±8, respectively. Two-year non-relapse mortality was significantly higher after MAC (62% vs. 34%, p=0.009). In counterpart, 2-year relapse rate was higher after RIC (14% vs 29%, p=0.02). Two-year DFS and OS were 30 and 34%, respectively. In univariate analysis, among patient-, disease- and transplant- factors studied only patients with high risk disease at maximal pre-transplant stage or transplanted 〉 18 months after diagnosis had significant poorer DFS (disease risk: 49% vs. 22%; time: 35% vs. 15%). However, in multivariate analysis, the only factor associated with decreased DFS was advanced disease (HR: 2.05; p= .01). Conclusion: These data indicate that UCBT is an acceptable alternative option to treat adults with high risk MDS or sAML without a HLA-matched related or unrelated bone marrow donor. Controlled disease at time of transplantation improves outcome. More investigations are needed to compare these results with outcomes after other stem cell sources from unrelated HSCT donor. Disclosures: No relevant conflicts of interest to declare.

Description: Abstract 791 The AML-12 randomized phase III trial of the EORTC and GIMEMA Leukemia Groups assessed the efficacy and toxicity of HD-AraC (3 g/m2/12 hrs for 4 days) combined with daunorubicin (50 mg/sqm for 3 days) and etoposide (50 mg/sqm for 5 days) vs SD-AraC (100 mg/sqm for 10 days) combined with the same drugs. Patients (pts) in complete remission (CR) received consolidation consisting of AraC (500 mg/sqm/12 hrs for 6 days) and daunorubicin (50 mg/sqm for 3 days). Subsequently an allogeneic (allo-SCT) or autologous stem cell transplantation (auto-SCT) was planned according to donor availability, cytogenetics and age. A 2nd randomization was performed after consolidation in pts without a donor: auto-SCT followed or not by low dose IL-2 (4-8 × 106 IU s.c. for 5 days per month) during one year. A total of 577 patients were required to be randomized for the 2nd question in order to reach 255 events (relapses or deaths) which would allow to detect a 11.5% increase in the 3-year disease-free survival (DFS) from 50% to 61.5% corresponding to hazard ratio (HR) = 0.70 (2-sided alpha=5%, statistical power=80%). Randomization was performed centrally; the 2nd randomization was stratified for induction treatment, cytogenetic/molecular genetic group, number of courses to reach CR, auto-SCT planned (No/Yes) and center. Intent-to-treat analysis was done. From 9/1999 till 1/2008, 2005 previously untreated AML pts (APL excluded), age

Description: Abstract 2666 Poster Board II-642 Immunotherapy based on natural killer (NK) cell infusions is a potential adjuvant treatment for many cancers. Such therapeutic application in humans requires large numbers of functional NK cells that have been isolated and expanded using clinical grade protocols. We established an extremely efficient cytokine-based culture system for ex vivo expansion of NK cells from hematopoietic stem and progenitor cells from umbilical cord blood (UCB). Systematic refinement of this two-step system using a novel clinical grade medium resulted in a therapeutically applicable cell culture protocol. The use of GBGM culture media in a clinical applicable protocol allows the ex vivo expansion and differentiation of CD34+ cells to more than 4-logs into CD56+CD3- NK cells with very high purity. These ex vivo-generated CD56+ cell products contain NK cell subsets expressing CD94/NKG2A and KIR as well express high levels of activating NKG2D and NCRs. Functional analysis showed that CD56+ cell products containing alloreactive NK cells efficiently kill myeloid leukemia and melanoma tumor cells as well as primary acute myeloid leukemia (AML) cells. We have currently translated the protocol to clinical scale production using a closed cell culture bioprocess. CD34+ selection from frozen UCB samples (n=9) using the CliniMACS device was optimized and the selection resulted in a CD34+ enrichment with a mean number of 2,2 ± 1,6 × 106 cells and a purity of 71 ± 14 % CD34+ cells. Validation experiments using the CliniMACS selected cells showed, that the generation of sufficient numbers of NK cells without contaminating T-cells or B-cells under a closed system process is feasible. The cell cultures using bags show a mean expansion of 1273 ± 506 fold (range 759–1770 fold, which generated 8,6×108 − 1,9×109 NK cells from cord blood-derived CD34+ cells within maximal 6 weeks of culture. The mean purity of the NK cell product was 71 ± 9 % (range 63–80%) of the total cells in the bag cultures. These NK cell products will be used for immunotherapy in elderly AML patients. This study is a phase I dose escalation study in a series of 12 AML patients who have successfully achieved CR (

Description: Abstract 2308 Poster Board II-285 Introduction: Dose-reduced conditioning followed by allogeneic stem cell transplantation has become a treatment option for patients with multiple myeloma. However, the experience using unrelated donor is limited. Patients and Methods: From 2002 to 2007, 49 myeloma patients with relapse to a prior autologous SCT were included in a prospective multicenter trial to determine the efficacy of a reduced melphalan (140 mg/m2)/fludarabine regimen followed by allogeneic SCT from unrelated donors. GvHD prophylaxis consisted of anti-lymphocyte globulin (ATG-Fresenius®), cyclopsorin A and short course of MTX. Results: No primary or secondary graft failure was observed and all patients showed leukocyte and platelet engraftment after a median of 15 and 19 days, respectively. Acute graft-versus-host disease (GvHD) grade II to IV occurred in 25% and chronic GvHD in 35% of the patients. Limited GvHD was seen in 29 % and extensive GvHD was seen in 6 % of the patients. Overall response rate at day 100 was 95% including 46% complete remission (CR). Cumulative incidence (CI) of non-relapse mortality at one year was 25% (95% CI: 13-37%) and significantly lower for HLA matched compared to mismatched SCT (10% vs. 53%, p=0.001). During follow-up 22 patients experienced relapse (54 %) resulting in a cumulative incidence of relapse at 1, and 3 years of 27% (95% CI: 14-40%) and 55% (95% CI: 40-70%), respectively. The median time to relapse was 318 days (r: 56 – 861). After a median follow up of 43 months, the estimated 5-year progression-free (PFS) and overall survival (OS) rates were 20% and 26%, respectively and were significantly better for matched in CR at day 100 (41 vs. 7%, p=0.04 and 56 vs. 16%, p=0.02). Conclusions: Allogeneic stem cell transplantation from unrelated donors after a reduced intensity regimen is feasible, but an optimal donor selection is mandatory for a low non-relapse mortality. The high relapse incidence remains a major concern should be improved by including posttransplant strategies to upgrade remission status. Disclosures: No relevant conflicts of interest to declare.

Description: Abstract 2307 Poster Board II-284 Objectives: T-cell depletion (TCD) is controversial in patients with chronic lymphocytic leukemia (CLL). While TCD is a powerful tool to prevent graft-versus-host disease (GVHD) after allogeneic hematopoietic cell transplantation (HCT) concern is raised about an increased incidence of relapse. The aim of this retrospective analysis was to study the impact of in vivo TCD in patients with CLL registered with the EBMT database. Patients and Methods: Patients with CLL who received allogeneic HCT from a matched sibling (SIB) or unrelated donor (UD) and cyclosporine-based GVHD prophylaxis between 2001 and 2008 were eligible. Patients who received ex vivo T-cell depleted grafts were excluded. The outcome of three major groups of patients was compared: Patients who were transplanted without TCD, those who received anti-thymocyte globulin (ATG) and patients who received alemtuzumab (CAM). Baseline and follow-up data were downloaded from the EBMT database. Results: 413 patients were eligible. 73% of patients had SIB donors and 27% matched UD. Reduced intensity conditioning regimens were applied for the majority of patients (82%). No TCD was used in 234 patients, while 100 patients received CAM and 79 patients ATG. The median follow-up after HCT was 22 months (1 to 92 months). Univariate comparisons of GVHD and the rates of DLI are reported for patients with matched sibling donors only. After SIB-HCT the cumulative incidence of acute GVHD II-IV was 7% with CAM, 22% with ATG and 34% without TCD (gray test, p=0.0001). Subsequently, 28% of patients with CAM received prophylactic donor lymphocyte infusions (DLI) compared to 5% of patients with ATG and 9% without TCD (p=0.03). DLI for any reason was given to 45% of patients with CAM, 24% with ATG and 15% without TCD (p=0.009). As a result of late-onset GVHD the incidence of chronic GVHD after TCD with CAM increased from 20% at 1 year to 60% at 4 years after SIB-HCT. At 4 years after HCT comparable cumulative incidences of chronic GVHD were observed (70% without TCD, 59% after ATG and 60% after CAM; p=0.1). For the whole cohort of patients 4-year overall survival (OS) and progression-free survival (PFS) were 57% (95% CI, 50% to 64%) and 44% (95% CI, 37% to 51%). At 4 years the cumulative incidence of relapse was 28% (95% CI, 17% to 39%) and the incidence of non-relapse mortality was 28% (95% CI 18% to 38%). In multivariate Cox regression analysis of PFS when GVHD prophylaxis without TCD was used as reference category the adjusted hazard ratio for TCD with CAM was 1.4 (95% CI, 0.9 to 2.2, p=0.2) and for TCD with ATG 1.4 (95% CI, 0.9 to 2.3, p=0.1). For relapse incidence the adjusted hazard ratio for TCD with CAM was 1.4 (95% CI, 0.7 to 2.6, p=0.3) and for TCD with ATG 1.0 (95% CI, 0.5 to 2.1, p=0.9) and for non-relapse mortality the adjusted hazard ratio for TCD with CAM was 1.4 (95% CI, 0.8 to 2.8, p=0.3) and for TCD with ATG 1.9 (95% CI, 1.0 to 3.5, p=0.06). Conclusion: In patients with CLL the combination of in vivo TCD and DLI appears to result in comparable rates of chronic GVHD and PFS compared to T-cell replete HCT. Disclosures: Schetelig: Bayer Schering: Research Funding.