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1 MINUTES CIBMTR WORKING COMMITTEE FOR GVHD Orlando, Florida Thursday, February 25, 2010, 2:45 pm 4:45 pm Statisticians: Scientific Directors: Steven Pavletic MD, National Cancer Institute Telephone: ; Fax: ; Mary Evelyn D. Flowers, MD, Fred Hutchinson Cancer Research Center Telephone: ; Fax: ; Alvaro Urbano-Ispizua, MD, Universitario Virgen del Rocio Telephone: ; FAX: ; Peigang Li, MS, CIBMTR Statistical Center Milwaukee Telephone: ; Fax: ; Tao Wang PhD, CIBMTR Medical College of Wisconsin Telephone: ; Fax: ; Mukta Arora MD, MS, CIBMTR Minneapolis Telephone: ; Fax: ; Stephen Spellman, MS, National Marrow Donor Program Telephone: ; Fax: ; 1. Introduction Dr. Pavletic opens the meeting at 2:45 PM. He introduced the GVHD team, including co-chair, scientific directors, and statisticians. Unfortunately, co-chair Dr. Alvaro Urbano-Ispizua is unable to join us today. Joining us today is a new co-chair, Dr. Corey Cutler, MD; Dana Farber Cancer Institute, Telephone: ; FAX: , Drs. Pavletic, Flowers and Cutler, chaired the meeting. The voting guidelines were presented. Dr. Mukta Arora asked Dr. Flowers to present a gift to Dr. Pavletic, the retiring co-chair, in acknowledgement of his leadership and hardwork he provided all these past years. Dr. Flowers recognized Dr. Pavletic efforts towards studies focused on chronic GVHD and welcomed Dr. Cutler as a great asset to have in the GVHD Working Committee as the new co-chair elected this year. Dr. Flowers asked each team member of the CIBMTR GVHD Working committee to do a selfintroduction, including the new co-chair, and the new statistician, Peigang Li. Dr. Flowers asked for approval of the 2009 Tandem minutes. The motion was passed and the minutes were approved. 2. Accrual summary Due to time limit, the accrual summary was not presented. It was indicated that this information is posted on the web site. 3. Published or submitted papers Dr. Arora indicated the papers that have been published as follows:

2 a. D96-01 Davies SM, Wang D, Wang T, Arora M, Ringden O, Anasetti C, Pavletic S, Casper J, MacMillan ML, Sanders J, Wall D, Kernan NA. Recent Decrease in Acute GVHD in Children with Leukemia Receiving Unrelated Donor Bone Marrow Tranplants. Biol Blood Marrow Transplant 15: , b. D01-91 Ratanatharathorn V, Logan B, Wang D, Horowitz M, Uberti JP, Ringden O, Gale RP, Khoury H, Arora M, Spellman S, Cutler C, Antin J, Bornhaüser M, Hale G, Verdonck L, Cairo M, Gupta V, Pavletic S. Prior rituximab correlates with less acute graft-versus-host disease and better survival in B-cell lymphoma patients who received allogeneic peripheral blood stem cell transplantation. Br J Haematol 145: , Studies in Progress - Below are the studies that were presented: a. GV05-02: Risk factors and outcome of agvhd after MUD (N Chao/ M Jagasia) Dr. Jagasia presented the study on behalf of the other PIs. The study is intended to identify prognostic factors for incidence of agvhd after allo-transplant and evaluate interactions of agvhd with other factors and outcomes such as age, OS, LFS, TRM, and REL. He focused on multivariate analysis of agvhd and OS. He showed background of the data: TX year 1995 to 2005, T-cell replete only, BM/PB, HLA-id/MUD (8/8 match), including disease AML, ALL, CLL and MDS It was decided to perform the analysis based on age group (pediatric/adults) and donor status (related/unrelated). The data includes many RIC patients (n=488). The agvhd models are for peds and adults, trying to predict Grade II-IV agvhd after transplant. The prognostic factors include FK506, GVHD prophylaxis (protective effect against agvhd), combinations of conditioning regimens (tbi vs no tbi), and sources of stem cells. Pediatric patients have a protective effect for MAC, no tbi and BM transplants. For adults, disease status, sex mismatch, GVHD prophylaxis are important predictive factors as well. A number of other factors also have protective effects. Age and some factors play important roles in OS for the four groups: peds/related, peds/unrelated, adults/related, adults/unrelated. The best overall protection comes from MAC, no tbi and BM transplants for related donors. For unrelated donors, the final predictors include recipient age, disease status at TX, CMV match, and HLA mismatch. b. GV04-02/GV05-03: Relapse in patients with cgvhd (M Boyiadzis/ DA Jacobsohn) This study merged from two studies. Part A of the Study was presented by Dr. Jacobsohn 1) The goal of this study was to identify risk factors and stratify high risk group of patients. The data has over 5000 patients with at least 5 year follow-up. The strength of the data is that it has over one third of pediatric patients (peds). The univariate analysis includes NRM, REL, DFS and OS. The OS at 5 years is 55% for patients of any age, and adults/peds has similar risk factors. Patients were divided into six risk groups based on the scores calculated from several factors, including age, acute GVHD status, donor, disease status, kps, etc. The risk strata clearly showed the separation of these risk groups. At the request of the GVHD committee, Dr. Jose Perez-Simon presented another chronic GVHD study from the EBMT (adults/peds) in hopes to identify other potential cohorts that could be used in a validation study for the risk stratification model results of the GV04/GV05-03 studies. The EBMT study included patients with chronic GVHD who survived without relapse at least 100 days after transplant. The OS at 5 years was 52%. Most patients with cgvhd of overlap type had progressive type of onset. Dr. Perez-Simon showed the results of the multivariate analysis of prognostic factors based on the NIH scoring system of cgvhd classification (mild, moderate, severe), and the type of GVHD onset (progressive, de novo, quiescent). Four subgroups of patients with different survival rates were identified. Both the NIH scoring system and the type of cgvhd onset had predictive values for outcomes after PBSCT.

3 There were questions about the adequacy of this cohort to serve as a validation cohort, due to difference in the patient selection ( the CIBMTR study included patients who did not survive 100). There were also inquiries about the availability and accuracy of KPS data at the time of diagnosis of cgvhd in both the US and EBMT cohorts. 2) Dr. Pavletic presented Part B of the study. It was shown that cgvhd is associated with fewer relapses after transplant. The goal is to identify cgvhd related features in the registry to differentiate relapse risk groups in a large cohort of patients. The analysis is on hold. The reason is different requirements of the data. Patients who did not relapse at 1 year will be subject to subsequent analysis where the data is still being checked and completed. This study is important in its ability to study the risk factor for late relapse of malignancies (i.e., > 1yr after transplant) among patients diagnosed with cgvhd at any time within 1 year and remained alive at 1 year. c. GV06-01: MTX vs non-mtx GVHD prophylaxis (C Cutler) The study has not gone very far for some good reasons. Without clean observations the study was unable to do the comparison between related and unrelated donors. Table 2 in the attachment shows the four groups of donor type and MTX. Marcelo Pasquini, co-pi of this study, volunteered to move forward and proceed with cleaner and simpler analysis to answer straightforward questions in RIC/NST comparing commonly used regimens in GVHD preventions. There are about 900 patients to be analyzed. d. GV06-04: Current trends in cgvhd (S Arai) Dr. Arai reviewed the trends study of 10-year period, , with 3 years follow-up. Patients must survive 100 days after first TX. Primary goal is to observe GVHD incident trends of last 10 years. Secondary objective is to look at severity trend using surrogate markers such as type of onset, organ involvement, disease status at DX, cgvhd-specific mortality, and overall mortality. Univariate and multivariate analyses determine the associations of clinical practices in terms of graft source, donor type, conditioning regimen, and how they affect incidence trend of cgvhd. Tables in the attachment show the trends with and without cgvhd over the 10 year period, as well as patient demographics broken down by year groups, , and Questions about the relevance of this study were raised. This study was argued to be a high priority because it will describe the incidence and severity trends of cgvhd in the context of clinical practice, especially with this large set of data involving multiple institutions. It will be a descriptive study. The primary objectives are (1) incidence of cgvhd; (2) time trends in cgvhd development. e. GV08-01: DRB1 ag and DR15 in GVHD/GVL in HLA matched Sibling transplant (M Battiwalla) The study s protocol has been finalized. DR15 has been shown to have effects on sensitivity to immunosuppressant therapy, GVHD, reduction in agvhd and relapse incidence, and could be a marker for greater susceptibility. The results have been evaluated in HLA-id sibs to show improved PFS and OS. The data includes patients with first TX. Exclusions are HLA mismatch (molecular typing), T-cell depletion, and synergeic donors. The study focuses on the main effect of presence of DR15 vs absence of DR15, and subsequently homogeneous vs. heterogeneous states, and *1501 vs *1502 groups. Common outcomes include GVHD, PFS and OS. In comparison, there is an abstract presentation in ASH 2009 involving DR15 but its multivariate analysis did not show differences in main outcomes. Thus, the current study is looking to answer the question that DR15 has major effect on the outcomes of graft vs. leukemia responses. f. GV08-02: agvhd vs GVT potential for graft engineering by T-cell dose (A Saad/ M Sharma)

4 The study is looking for an optimal T cell dose that can balance the survival of allo TX and GVHD. The hypothesis is to test whether high grade agvhd and the GvT are separable, and if there exists a cell dose range of both CD4+ and CD8+ T-cell which promote GvT. From a small retrospective study, the statistical model was used to identify a dose range for CD4+/CD8+ where patients with lower cell dose had a significant risk for Grade II-IV agvhd while the survival curve did not show difference for higher or lower doses. This would indicate that we can reach the same survival by giving patients lower cell dose without risk of getting agvhd. The CIBMTR registry data shows 17% patients with Grade III-IV agvhd. The study looks at both BM and PBSC transplants. g. GV08-03: Risk factors for agvhd after matched Sib HCT (RIC) for Leukemia (O Ringdén) It is to compare RIC with MAC patients as well as evaluate risk factors for Grades II-IV agvhd. Patients population are , HLA-id sibs and 8/8 matched donors, PB or BM, first transplant only, and T-cell depletion will be excluded. Outcomes include cumulative incidence of agvhd and risk factors for grades II-IV and III-VI acute GVHD between RIC and MAC. Univariate analysis shows that there is a difference for Grade II-IV between RIC and MAC but no difference for Grade III-IV. This study has a fair amount of overlap with GV05-02 so it would be better to restrict to risk factors only and additionally capture the onset of GVHD. h. GV08-04: Relapse outcome w/wo cgvhd (M Boyiadzis) The study looks into whether there is any difference between patients without cgvhd after allo TX and those with cgvhd, describes outcomes and prognostic variables for patients who relapse, and characteristics of patients who progressed. There are over 2100 patients who meet the selection criteria in the CIBMTR registry. i. GV08-05: cgvhd in RIC (S Pavletic) It is in the protocol development stage and a lot of good comments along the way have been considered. It looks into the prognostic factors for development of cgvhd and outcomes after RIC transplant. Currently the study only includes PBSCT and questions were raised to include BM. The idea is that the biological modifying factors in association with prognostic factors have not been well addressed. This study was compared and contrasted to Dr. Arai s trends in chronic GVHD study (GV06-04) which is looking at all patients including RIC and the onset of GVHD. j. GV08-06: GVL after 8/8 URD vs HLA matched sib RIC or NST (O Ringdén) It compares GvL effect for RIC or NST patients from unrelated or HLA-id sibs donors. Eligible patients are transplants and outcomes include relapse, TRM and DFS, and different grades of agvhd/cgvhd. Dr. Ringdén presented the latest table of available cases for analysis. The ages for donor and recipient are important factors. 5. Deferred Studies a. GV05-05 DLI after NST/focus on GVHD (DR Couriel/ RM Saliba) Dropped. b. GV07-01 Stem cell dose in unrelated BMT (HJ Khoury) Dropped (or Merge with a study in GSWC) 6. Future/ Proposed studies a. PROP Conditioning/Graft Source in G-CSF induced GVHD

5 (O Ringdén) There is a clinical controversy whether G-CSF increases GVHD or not. A European study suggests that G-CSF increases GVHD as well as survival but CIBMTR studies did not show such an effect. A recent mouse model study on Nature prompted the current proposal hypothesized that G-CSF induces GVHD in patients with TBI or BM graft. G-CSF given before day 14 induces GVHD. Standard outcomes are analyzed. The characteristics table was presented. There are about 8000 patients and almost 1/3 of them were treated with G-CSF. A question suggested excluding patients with graft failures. 7. Other Business The meeting adjourned at 4:36PM. Dr. Jose Perez-Simon will be added to the GVHDWC contact list. The GVWC meeting agreed to drop the following two studies: Study # and PI Status at tandem 02/10 Anticipated status by 06//10 GV05-05 (DR Couriel/ RM Saliba) Deferred Dropped GV07-01 (HJ Khoury) Deferred Dropped The voting score result is as follows: Study/Proposal Status subtotal votes average score PROP GV06 01 Prot dev GV06 04 Prot dev GV08 02 Prot dev GV08 04 Prot dev GV08 06 Prot dev Note: Votes and scores are not related to priority for GV Top priorities are usually given to those already in advanced status.

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