ALBERT

Description: Abstract 285 Background: KW-0761 is a defucosylated, humanized, monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC; Potelligent®) that binds to CC chemokine receptor 4 (CCR4). CCR4 is expressed on the surfaces of cells comprising several T-cell malignancies such as ATL, peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL). A phase I study of KW-0761 in patients with CCR4-positive ATL and PTCL demonstrated that 4 weekly intravenous infusions of KW-0761 were well tolerated up to 1.0 mg/kg and it showed encouraging clinical activity with an overall response rate (ORR) of 31.3% (4 of 13 ATL and 1 of 3 PTCL) in 16 patients (J Clin Oncol 2010;28:1591-8). Methods: A multicenter phase II study of KW-0761 has been conducted for relapsed patients with CCR4-positive ATL to evaluate its efficacy, pharmacokinetics (PK), safety and immunogenicity. Patients were planned to receive 8 weekly intravenous infusions of KW-0761 at 1.0 mg/kg. The primary endpoint was ORR. Objective responses were assessed after the 4th and 8th infusions of KW-0761 according to the response criteria for ATL (J Clin Oncol 2009;27:453-9) by each investigator and the independent efficacy assessment committee. The number of patients required was estimated to be 25, for 90% power to detect a lower limit of the 95% confidence interval (CI) exceeding the 5% threshold of ORR, based on the assumptions that the minimum required response ORR to a new drug for relapsed ATL is 5% and the expected ORR to KW-0761 is 30%. Results: Twenty-seven patients (12 males and 15 females) were enrolled and received KW-0761. The median age was 64 years (range: 49–83). The disease subtypes of ATL consisted of 14 acute-, 6 lymphoma-, and 7 chronic-types with unfavorable prognostic factors. Among the 27 patients enrolled, 14 patients (52%) completed the protocol treatment of 8 infusions. Eleven patients (41%) discontinued the protocol treatment because of progressive disease, and the remaining 2 discontinued because of skin rash or the concurrent colon tumor. The treatment-related grade (G) 2 or greater adverse events (AEs) were lymphopenia (96%), leukopenia (56%), skin rash (52%), neutropenia (33%), thrombocytopenia (26%), AST increase (26%), ALT increase (22%), hypoxemia (19%), anemia (15%), pruritus (15%), g-GTP increase (15%) and hypophosphatemia (15%). G2 or greater Infusion-related toxicities were observed in 22 of 27 patients (81%) including 1 G3, but immediately recovered after treatment with systemic steroids. Treatment-related severe AEs (SAEs) were observed in 5 patients, including a Stevens-Johnson syndrome (G3) and 4 skin rashes (each G3). All these AEs also improved by steroids. PK analysis demonstrated that Cmax and trough (C168h) after the 8th infusion was 38,853 ± 11,267 and 25,934 ± 10,193 ng/mL, respectively, and T1/2 after the 8th infusion were 457 ± 144 h. No anti-KW-0761 antibody has been detected. Among the 26 patients evaluable for efficacy, KW-0761 exhibited an ORR of 54% (14/26; 95% CI, 33 to 73) (acute: 6/14 patients, lymphoma: 3/6 patients, chronic: 5/6 patients) including 7 complete responses (CRs) (27%; 95% CI, 12 to 48) and 7 partial responses (PRs). These are remarkable results, considering that the ORR of relapsed or refractory patients with ATL to a single-agent chemotherapy has been reported to be low (7 to 39%). Response rates according to the affected disease lesion were 100% (13 patients, all CR), 71% (5 of 7 patients), and 38% (5 of 13 patients), respectively, for peripheral blood, skin, and lymph node disease. Conclusions: KW-0761 is a highly effective agent with acceptable toxicity profiles in relapsed patients with CCR4-positive ATL who have no standard therapies. A multicenter, randomized study for untreated ATL patients to compare mLSG15 (a dose-intensified multi-agent regimen, J Clin Oncol 2007;25:5458-64) + KW-0761 with mLSG15 alone has been initiated. Disclosures: Ogura: Kyowa Hakko Kirin Co Ltd: Consultancy. Akinaga:Kyowa Hakko Kirin Co Ltd: Employment.

Description: Abstract 3417 Background: Now, imatinib has been established as a first line therapy for the patients with chronic myelogenous leukemia (CML) in chronic phase (CP), and a standard initial dose is 400 mg daily. Although less than 300 mg showed unsatisfactory results, 300 mg or more appears effective in some patients intolerant to standard dose. However, large studies have not yet explored the response to lower dose of imatinib. In this CML202 study, although initial dose of imatinib was scheduled to be 400 mg, many patients actually received reduced dose mainly due to adverse events. However, overall efficacy and outcomes had been comparable to other studies. We performed subgroup analysis regarding long-term survivals according to the mean daily dose during the first 6 months, 12 months, and 24 months, respectively. We also measured imatinib plasma trough concentration (Cmin) in patients receiving imatinib at a dose of 300 mg or 400 mg, and compared efficacy and survivals between them. Methods: The prospective multicenter study of imatinib therapy in Japanese patients with newly diagnosed CML-CP was conducted in Japan Adult Leukemia Study Group (JALSG CML202 study). The objectives of this study were to determine the efficacy, safety and long-term outcomes of imatinib therapy in patients with newly diagnosed CML-CP. Primary end point of imatinib therapy was overall survival (OS). Initial daily dose of imatinib was 400 mg. The plasma concentration of imatinib was measured using liquid chromatography-tandem mass spectrometry. Results: 488 patients were enrolled between 2002 and 2006, and data at a median follow-up of 66 months were analyzed. The cumulative best response rates of major cytogenetic response (MCyR), complete cytogenetic response (CCyR) and major molecular response (MMR) were 99%, 98% and 81%, respectively. At 66 months, the estimated rate of overall survival (OS) was 93% (95% CI, 90 to 96), and that of survival without progression to accelerated phase (AP) or blast crisis (BC) was 97% (95% CI, 96 to 99). In the landmark analysis at 12 months or 18 months according to the cytogenetic response or the molecular response, patients who had CCyR or MMR showed significantly better event free survival (EFS) rates than those who had not, respectively. Mean daily doses of imatinib administered during the first 24 months were 400 mg or more (400 mg group) in 294 patients, less than 400mg and 300mg or more (300 mg group) in 108 patients, and less than 300 mg (200 mg group) in 86 patients. The efficacy and outcomes at 66 months were evaluated according to the mean daily dose (400, 300, 200 mg group). The estimated rates of OS were 98%, 92% (P=0.09), and 74% (P

Description: Abstract 3117 Background: Angioimmunoblastic T-cell lymphoma (AITL) is one of the major types of peripheral T-cell lymphoma (PTCL), with T follicular helper cells (TFH) reported to be the normal counterpart cell type. The disease generally presents with poor prognosis following conventional chemotherapy treatments. Furthermore, existing prognostic factors or predictive models for non-Hodgkin lymphoma are not useful in the prognostification of AITL. Identification of novel prognostic factors is therefore vital. Unfortunately, the number of studies using a large cohort of patients with AITL has so far been limited. Patients and Method: To elucidate the clinicopathological characteristics of AITL in Japan, we retrospectively analyzed 213 patients who were diagnosed with AITL between January 1990 and September 2008 from 31 participating hospitals. Patients with AITL were eligible for analysis only if their diagnosis was confirmed by histopathological and immunohistochemical criteria in accordance with the WHO classification. For immunohistochemical analysis, we evaluated CD10, CXCL13, PD-1 and EBER-ISH in addition to routine immunostaining. Clinical data was retrospectively collected from case reports. Patients received treatment for AITL according to the respective institutional protocols. Overall survival (OS) and progression free survival (PFS) were analyzed by using the log-rank test, and results expressed as Kaplan-Meier plots. Cox proportional hazard regression analysis with OS and PFS was performed to identify potential independent prognostic factors. This study was approved by the institutional review board of participating hospitals and complied with the provisions of the Declaration of Helsinki. Result: The median patient age was 67 years (range: 34–89 years), with 74% of patients older than 60 years. The female:male ratio was 1:1.8. Ninety percent of patients displayed Stage III or IV disease, and 23% of patients involved more than 1 extranodal site. B-symptoms and bone marrow involvement were present in 60% and 30% of patients, respectively. Laboratory findings showed anemia (male: Hb 400 mg/dl in 37%, and elevated serum LDH levels in 75% of patients, respectively. According to the international prognostic index (IPI) and prognostic index for PTCL-NOS (PIT) score, patients were categorized as follows; IPI: Low (L), 10% (22/199); Low-intermediate (LI), 20% (39/199); High-intermediate (HI), 39% (77/199); and High (H), 31% (61/199), respectively, and PIT: Group1 (G1), 4% (8/201); Group2 (G2), 19% (38/201); Group3, 42% (85/201); and Group4, 35% (70/201), respectively. In terms of the initial series of treatments, 84% of patients received anthracycline-based chemotherapies. With a median follow-up duration of 42 months in surviving patients, 3-year OS and PFS were 54% and 39%, respectively. IPI was predictive for OS (3-years OS: L, 84%; LI, 65%; HI, 54%; H, 38%; Log-rank test, p

Description: As we previously reported(Blood, 2005;NST-1), allogeneic stem-cell transplantation from an HLA identical sibling donor with reduced-intensity conditioning(RIST) consisting of fludarabine(FL), busulfan(BU) and antithymocyte globulin(ATG) for adult T-cell leukemia(ATL) patients(pts) appears to be a feasible treatment modality. Disease relapse, however, was the main cause of treatment failure. We conducted a second phase 1 clinical trial of RIST for ATL pts without ATG(NST-2). Objectives: We evaluated the safety and feasibility of RIST for ATL using the same conditioning regimen except that we did not use ATG. Patients and Methods: Between September 2003 and January 2006, 14 pts ranged from 50 and 62 years of age were enrolled. After the conditioning regimen with FL 30 mg/m2/d on days -8 to -3, BU 4 mg/kg/d on days -6 to -5, they received G-CSF-mobilized PB stem cells. The primary end points were either engraftment, as evaluated by the achievement of complete donor chimerism(CC) before d90, or the occurrence of early transplant-related mortality(TRM) before d100. Results: All 14 pts achieved CC before d90, while two pts died of TRM before d100, thus demonstrating the successful results for the primary end points. The incidence of severe acute GVHD(grade III-IV) was 21%. A disease relapse occurred in 6 pts from d30 to d775, 5 of whom eventually died of ATL. As of July 31, 2006, 6 pts are still alive, while 8 died of either ATL(5 pts) or TRM(3 pts). The event free and overall survivals(EFS, OS) at 2 years were 40% and 43%, respectively. Among the 12 evaluable pts, the HTLV-1 proviral load decreased to an undetectable level after RIST in 9 pts. Therefore, the results of CC before d90(14/14versus[vs]14/15*), TRM before d100(2/14vs2/15*), severe acute GVHD(3/14vs5/15*), disease relapse(6/14vs9/15*), 2 year-EFS (40%vs20%*) or -OS(46%vs33%*) and the anti-HTLV-1 effects(9/12vs8/15*) were closely comparable with those of NST-1*. The incidence of early disease recurrence before d100 tended to be low(21%[3/14]vs44%*[7/16]*), thus resulting in a longer mean survival time(804 days vs 262 days*) after RIST. Conclusion: Our two studies(NST-1, NST-2) confirmed that, whether ATG was administered or not, RIST is considered to be a feasible treatment modality. Moreover, conditioning without ATG may improve the survival by delaying a disease relapse without increasing the severity of acute GVHD. A third study (phase 2 trial of RIST without ATG) is currently underway.

Description: Background We previously reported that twice-weekly intravenous bortezomib plus doxorubicin and intermediate-dose dexamethasone (iPAD) therapy induced a high complete response (CR) rate of 30% and prolonged remission duration of median 12.1 months in patients with relapsed or refractory myeloma. However, sensory neuropathy was observed in 78% of the patients with grade 3 neuropathy in 22%. To reduce the toxicity, we conducted once-weekly subcutaneous bortezomib therapy given in combination with oral cyclophosphamide and dexamethasone (sVCD). Methods This was a phase 2 multicenter study conducted by the Kyushu Hematology Organization for Treatment Study Group (K-HOT). sVCD regimen consists of bortezomib 1.3 mg/m2 administered subcutaneously, and cyclophosphamide 300 mg/m2 and dexamethasone 40 mg given orally on days 1, 8, 15 and 22. The treatment was repeated at a 5-week interval for 6 cycles. The primary endpoint was to determine the complete response rate. The toxicities including sensory neuropathy and injection site reaction were analyzed as the secondary endpoint. The study was approved by the Institutional Review Board at each participating center and was registered in University hospital Medical Information Network (UMIN000006490). All patients provided a written-informed consent. Results Thirty-one patients with median age of 69 (range, 43-87) were entered into this study. The numbers of prior chemotherapy line were 1 in 39%, 2 in 23%, and more than 3 in 39% of the patients. Bortezomib, lenalidomide and thalidomide had been given in 52%, 26% and 16%, respectively. CR was achieved in 16%, partial response (PR) in 26%, and minimal response (MR) in 29%, resulting in overall response rate of 71%. Grade 3/4 neutropenia was observed in 35%/3%, thrombocytopenia in 16%/13%, and anemia in 45%/0% of the patients. Grade 3 to 4 non-hematological toxicities were uncommon; the highest incidence of grade 3 events were rash, hyponatremia and hyperglycemia observed in 6%, while no grade 4 events were reported. Grade 3 sensory neuropathy developed in 3% and grade 2 in 19%. Injection site reactions were observed in 39%, but all of them were grade 1. Conclusion sVCD therapy containing bortezomib administered subcutaneously in once-weekly schedule successfully reduced the incidence and severity of sensory neuropathy with moderate response rate. Disclosures: Miyamoto: Kyushu University Hospital: Employment.

Description: Abstract 2287 The TARGET system is an online database that can be easily accessed by physicians. The TARGET system is operated by the Japanese Society of Hematology. The registration of one's own chronic myeloid leukemia (CML) patients in the TARGET system makes it possible to share experiences among physicians, and, thus, may facilitate appropriate treatment for patients. Patients participating in clinical trials are usually selected according to strict eligibility criteria. Previous publications have questioned the use of other overly restrictive exclusion criteria in clinical oncology trials. In practical situations, however, the clinical features of patients are much more heterogeneous than those defined by the selection criteria in clinical trials. From this point of view, the TARGET system might provide more practical and general features compared with the IRIS study. Patients were registered in the TARGET system from October 2003 to March 2010 in Japan. A total of 1,236 patients from 176 hospitals were registered in Japan. We analyzed data from 639 CML chronic phase patients not receiving prior therapy registered in this system. After 90 months follow-up, high survival rates were demonstrated for imatinib-treated newly diagnosed CML patients, with event-free survival (EFS), progression-free survival (PFS), and overall survival (OS) rates of 79.1, 94.8, and 95.1%, respectively. A landmark analysis of 296 patients who showed a complete cytogenetic response (CCyR) at 12 months after the initiation of imatinib treatment revealed that, at 90 months, 99% of patients (95% CI, 98 to 100) had not progressed to accelerated phase (AP) or blastic crisis (BC). The patients showing a CCyR and a reduction of at least 3 log levels of BCR-ABL transcripts after 18 months of treatment had an estimated survival rate without CML progression of 100% at 84 months.By 84 months, 315 patients had achieved an MMR. A total of 226 of 315 patients (71.7%) achieved undetectable BCR-ABL by 84 months. We therefore analyzed the probability of achieving undetectable BCR-ABL based on the molecular response at 12 and 18 months. The probability of achieving undetectable BCR-ABL by 72 months in patients with an MMR at 12 months was 86.5%, compared with 64.7% for those without an MMR (P

Description: Introduction: Empiric antifungal therapy (EAT) is recommended for persistent or recurrent febrile neutropenia based on an old randomized controlled trial, but such treatment is apparently overtreatment for the majority of patients. On the other hand, preemptive therapy triggered by positive blood tests for fungal antigens and/or imaging study findings was shown to increase the incidence of invasive fungal infection, and thus, a risk-based approach is important. The D-index, which is defined as the area over the neutrophil curve during neutropenia and hence reflects both the duration and depth of neutropenia (Figure 1A), enables real-time monitoring of the risk of invasive fungal infection. Previous studies showed that the cumulative D-index (c-D-index), which was calculated as cumulative D-index from the onset of neutropenia (Figure 1B), had high negative predictive values for invasive mold infection or pulmonary infection with cutoff values of 5,800 or 5,500 in high-risk neutropenic patients [J Clin Oncol 2009; 27: 3849-54. Biol Blood Marrow Transplant 2010; 16: 1355-61]. Methods: We investigated a novel approach, called D-index-guided early antifungal therapy (DET) and compared it to EAT in high-risk neutropenic patients. In the EAT group, empiric antifungal therapy was started for persistent (〉=4 days) or recurrent febrile neutropenia. For patients with persistent or recurrent febrile neutropenia in the DET group, preemptive antifungal therapy was applied until c-D-index reached 5,500, but antifungal agent was initiated after c-D-index exceeded 5,500, even if there was no significant finding in serum fungal makers or imaging studies, to prevent excessive invasive fungal infection. Micafungin at 150 mg/day was administered as EAT or DET in this study. We randomized 423 patients who underwent chemotherapy or hematopoietic stem cell transplantation for hematological malignancies, in which predicted period of neutropenia exceeded 7 days, into the EAT group or the DET group, and 413 were eligible for intent-to-treat analyses (201 patients in the EAT group, 212 patients in the DET group). The prophylactic use of fluconazole or itraconazole was allowed. Primary endpoint was the development of proven/probable invasive fungal infection. Results: Backgrounds of the patients were similar between the 2 groups (Table 1). Invasive fungal infection (proven/probable/possible) was observed in 12 patients (6.0%) of the EAT group and 5 patients (2.4%) of DET group, respectively. Proven/probable invasive fungal infection was identified in 5 patients (2.5%) of the EAT group and 1 patient (0.5%) of DET group, which fulfilled the predetermined criteria of non-inferiority of the DET group. Regarding the pathogens, the EAT group included 1 case of candidemia and 4 cases of invasive pulmonary aspergillosis, and the DET group included one fusariosis. The survival rate of the EAT and DET group was 98.0% vs. 98.6% at day 42 and 96.4% vs. 96.2% at day 84, respectively. During the observation period, 31 patients died due to disease progression (n=19), infection (n=5) or other causes (n=7). Causes of infection related mortality included Pseudomonas aerginosa infection (n=2), fusariosis (n=1), toxoplasmosis (n=1) and septic shock by unknown pathogen (n=1). The frequency of micafungin use was significantly lower in the DET group than the EAT group (32.5% vs. 60.2%, P

Description: Introduction: Imatinib have dramatically changed the natural history of chronic myeloid leukemia (CML) leading to significant improvement in clinical outcome and survival rates. Recently, treatment free remission (TFR) is one of the goals in CML treatment, and some prospective trials suggest that imatinib therapy may be safely discontinued in CML patients with deep and sustained molecular responses (Mahon Lancet Oncol 2010, Ross Blood 2013, Rousselot JCO 2014). The purpose of this study was to confirm TFR in Japanese CML patients and to define prognostic biomarkers of successful TFR after stopping imatinib. Methods: Japanese CML patients on imatinib treatment in confirmed deeper molecular response (DMR) for at least two year (〉4 log reduction on imatinib therapy for 〉24 months confirmed by four consecutive PCR tests) and under imatinib treatment for at least 3 years were eligible. Patients treated with other tyrosine kinase inhibitors or who received stem cell transplantations were excluded. MR4.5 was confirmed at the beginning of this study using Ipsogen BCR-ABL1 M-BCR IS-PCR kit in a central laboratory (Sysmex, Kobe, Japan). Primary endpoint was the major molecular remission (MMR) rate at 12 months after stopping imatinib. Molecular recurrence of CML was defined as loss of MMR according to A-STIM criteria (Rousselot JCO 2014). Results: From November 2013 to March 2014, 77 CML patients in chronic phase from 26 institutions were enrolled in this study. Nine were excluded (consent withdrawal n=1, not eligible n=8). Of the eligible 68 patients, 38.2% were female. Median age was 55.0 years (range, 23 to 84), and 13.2% and 16.2 % were high-risk according to EUTOS and Sokal Scores. Thirteen patients were treated with interferon prior to imatinib therapy. Median duration of imatinib treatment was 8 years (range, 3-12 years). The duration of imatinib treatment was less than 5 years in 12%, 5-8 years in 34% and 〉 8 years in 54% of pts. Time to MMR was 11.5 months (25%-75%, 7.5-22.7 months) and time to DMR (not detected by PCR) was 30.6 months (25%-75%, 17.6-59.9 months). Among the 68 patients, 46 patients (67.6%, 95%CI: [56.5% to 78.8%]) remained without molecular recurrence the first 12 months according to A-STIM criteria, defined as loss of MMR. Moreover, 43 patients (63.2%, 95%CI: [51.8% to 74.7%]) remained without molecular recurrence the first 12 months according to STIM criteria, defined as two consecutive loss of MR4.5 with 1 log increase. On the other hand, 22 patients who lost MMR were treated again with imatinib and all patients achieved MMR within 6 months. Time to 2nd MMR was 40 days. Although there was a trend for a better TFR rate for patients treated longer with Imatinib (Figure 1), no significant difference could be observed for molecular relapse within 12 months according to clinical characteristics including age, sex, Sokal risk score, prior IFN, and time to MMR/DMR (Table 1). Ten patients (15%) showed "withdrawal syndrome" which is transitory musculoskeletal pain within several weeks after imatinib discontinuation, and all patients except one recovered without any treatments. Conclusion: According to the A-STIM criteria, around 70% of patients with deep and sustained molecular responses could safely stop imatinib. TFR in this prospective Japanese clinical study was higher than previously reported, probably because there were much more patients who treated with imatinib for longer duration than previous studies. We will report prognostic factors in the exploratory research of JALSG-STIM213 study including T/NK-cell profiling in peripheral blood, BIM deletion polymorphism, and ABCG2 421C/A polymorphism at this ASH meeting. Table 1. Table 1. Figure 1. Figure 1. Disclosures Takahashi: Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Otsuka: Membership on an entity's Board of Directors or advisory committees; Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Celgene: Speakers Bureau; Astellas: Speakers Bureau; Masis: Consultancy; Sysmex: Research Funding, Speakers Bureau; BMS: Honoraria, Research Funding, Speakers Bureau. Hatta:CHUGAI PHARMACEUTICAL CO. LTD: Honoraria; Kyowa Hakko Kirin CO., Ltd, Japan: Honoraria; Celgene K.K.: Honoraria. Usuki:Fuji Film RI Pharma: Other: personal fees; Fujimoto Pharmaceutical: Research Funding; Otsuka Pharmaceutical: Research Funding; Eisai: Research Funding; Shionogi: Other: personal fees; MSD: Other: personal fees, Research Funding; Nippon Shinyaku: Other: personal fees, Research Funding; Astellas: Research Funding; Chugai Pharmaceutical: Other: personal fees; Takeda Pharmaceutical: Research Funding; Kyowa Hakko Kirin: Other: personal fees, Research Funding; SymBio Pharmaceutical: Other: personal fees, Research Funding; Sanofi: Other: personal fees, Research Funding; Novartis: Other: personal fees, Research Funding; Boehringer Ingelheim: Other: personal fees, Research Funding; Celgene: Other: personal fees, Research Funding; Sumitomo Dainippon Pharma: Other: personal fees, Research Funding; Taiho Pharmaceutical: Other: personal fees, Research Funding; Shire: Research Funding; GlaxoSmithKline: Other: personal fees, Research Funding; Bristol-Myers Squibb: Other. Kobayashi:Gilead Sciences: Research Funding. Naoe:Otsuka Pharmaceutical Co., Ltd.: Research Funding; Chugai Pharmaceutical Co., Ltd.: Patents & Royalties; Pfizer Inc.: Research Funding; Toyama Chemical CO., LTD.: Research Funding; Nippon Boehringer Ingelheim Co., Ltd.: Research Funding; Astellas Pharma Inc.: Research Funding; Celgene K.K.: Research Funding; FUJIFILM Corporation: Patents & Royalties, Research Funding; Kyowa Hakko Kirin Co., Ltd.: Patents & Royalties, Research Funding.

Description: Key Points An improvement of 4-year OS for acute and lymphoma types of ATL was observed in comparison with that of the 1991 report. The prognosis of the smoldering type ATL was worse than expected from the 1991 report.

Description: Angioimmunoblastic T-cell lymphoma (AITL) is a major type of peripheral T-cell lymphoma (PTCL). To elucidate the clinicopathologic characteristics and prognosis of AITL in Japan, we retrospectively analyzed 207 patients with AITL. The median patient age was 67 years (range, 34-91 years), with 73% of patients older than 60 years. With a median follow-up of 42 months in surviving patients, 3-year overall survival (OS) was 54% and progression-free survival (PFS) was 38%. The International Prognostic Index (IPI) and the prognostic index for PTCL, not otherwise specified (PIT) were predictive for OS in this analysis. Multivariate analysis found that age older than 60 years, elevated white blood cell (WBC) and IgA levels, the presence of anemia and thrombocytopenia, and extranodal involvement at 〉 1 site were significant prognostic factors for OS, and IgA, anemia, and mediastinal lymphadenopathy were significant prognostic factors for PFS. A novel prognostic model consisting of the prognostic factors for OS was successfully constructed. In conclusion, IPI and PIT were still useful for prognostication of AITL, and other factors, including those not used in IPI, such as IgA, anemia, WBC count, thrombocytopenia, and mediastinal lymphadenopathy, also significantly affected prognosis. Future investigations for IgA as a unique prognostic factor are warranted.