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Bosansko-hercegovačka kooperativna grupa za hematološke bolesti

First Interim Efficacy and Safety Analysis of an International Phase III Randomized Trial in Newly Diagnosed Systemic Peripheral T-Cell Lymphoma Treated with Chemotherapy with or without Alemtuzumab and Consolidated by High Dose Therapy

ACT-1 trial in PTCL, (alemtuzumab + CHOP-14) preliminary findings: acceptable safety, 67% ORR in total patient population (57)


Program: Oral and Poster Abstracts
Type: Oral
Session: 624. Lymphoma - Therapy with Biologic Agents, excluding Pre-Clinical Models: Novel Agents and Targeted Therapies

Sunday, December 9, 2012: 12:30 PM

Sidney Marcus Auditorium, Level 4, Building A (Georgia World Congress Center)

Francesco d'Amore1, Sirpa Leppä, Professor2, Maria Gomes da Silva3*, Thomas Relander4*, Peter De Nully Brown5, Eckhart Weidmann6*, Grete Fossum Lauritzsen7*, Antonio Pezzutto8*, Achiel Van Hoof9, Michel van Gelder10*, Jeanette K Doorduijn, MD, PhD11,12,13, Ka Lung Wu, MD, PhD14, J.C. Kluin-Nelemans15, P.J. Lugtenburg16, Milada Jankovska17*, Mats Merup18*, Unn-Merete Fagerli19*, Jan Walewski20, Hans Hagberg21*, Jose Mario Mariz22, Per Boye Hansen23*, Thomas Nösslinger24*, Ann Janssens25*, Lena Brandefors26*, Hilde Demuynck27, Martyn Ronald Schaafsma28, Ilse Christiansen29, David Salek30*, Sirkku Jyrkkiö31*, Vit Prochazka32*, Josee Zijlstra33*, L. Böhmer34*, Richard Greil, MD35, Wendy Stevens36*, Rob Fijnheer37*, Marinus van Marwijk Kooy38*, Matthias Grube39*, Georg Hopfinger40*, Eric Van den Neste41*, Esa Jantunen42*, Lorenz Trümper43*, Gerald Wulf43, Bettina Altmann44*, Marita Ziepert44*, Markus Loeffler44* and Helle Toldbod1*

1Department of Hematology, Aarhus University Hospital, Aarhus, Denmark
2Department of Oncology, Helsinki University Central Hospital, Helsinki, Finland
3Portuguese Institute of Oncology, Lisbon, Portugal
4Department of Oncology, Lund University Hospital, Lund, Sweden
5Dept. of Hematology, Rigshospitalet, Copenhagen, Denmark
6Department of Hematology and Oncology, Krankenhaus Nordwest, Frankfurt, Germany
7Oncology, Oslo University Hospital, Norway
8Hematology/Oncology, Charité Universitätsmedizin Berlin, Berlin, Germany
9University Hospital St-Jan, Brugge, Belgium
10Hematology, Maastricht University Medical Center, Maastricht, Netherlands
11Department of Hematology, Erasmus MC, Rotterdam, Netherlands
12hematology, Erasmus Medical Center Rotterdam, Rotterdam, Netherlands
13Hematology, Erasmus MC University Medical Center/Daniel den Hoed Cancer Center, Rotterdam, Netherlands
14Hematology, ZNA Stuivenberg, Antwerp, Belgium
15Department of Hematology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands
16Dept. of Hematology, Erasmus MC, Rotterdam, Netherlands
17Department of Clinical Hematology, Third Faculty of Medicine, Charles University Hospital Kralovske Vinohrady, Prague, Czech Republic
18Department of Hematology, Karolinska University Hospital, Stockholm, Sweden
19Oncology, St. Olavs University Hospital, Norway
20Department of Lymphoproliferative Diseases, Maria Sklodowska-Curie Memorial Institute and Cancer Center, Warsaw, Poland
21Department of Oncology, Uppsala University Hospital, Uppsala, Sweden
22Hematology, IPO Porto, Porto, Portugal
23Hematology, Herlev University Hospital, Denmark
243rd Med. Dept. for Hem. & Onc., Hanusch Hospital, Vienna, Austria
25Department of Hematology, University Hospitals Leuven, Leuven, Belgium
26Dept of Medicine, Sunderby Hospital, Luleå, Sweden
27Department of Haematology, Heilig Hartziekenhuis Roeselare-Menen, Roeselare, Belgium
28Medisch Spectrum Twente, Enschede, Netherlands
29Department of Hematology, Aalborg Hospital, Aarhus University Hospital, Aalborg, Denmark
30Dept Haemato-oncology, University Hospital Brno, Brno, Czech Republic
31Oncology and Radiotherapy, Turku University Central Hospital, Turku, Finland
32Department of Hematology, University Hospital Olomouc, Olomouc, Czech Republic
33Dept. of Hematology, VU University Medical Center, Amsterdam, Netherlands
34Dep. oF Hematology, Haga Ziekenhuis, Den Haag
35IIIrd Medical Department with Hematology and MEdical Oncology, Paracelsus Medical University Salzburg, Salzburg, Austria
36Dep. Hematology, University Medical Center St. Radboud, Nijmegen
37Department of Internal Medicine, Meander Medical Center, Amersfoort, Netherlands
38Department of Internal Medicine, Isala Klinieken, Zwolle, Netherlands
39Department of Hematology and Oncology, University Clinic Regensburg, Regensburg, Germany
40Department of Internal Medicine III, University Hospital Salzburg, Salzburg, Austria
41Hematology Department, Cliniques universitaires UCL Saint-Luc, Brussels, Belgium
42Department of Medicine, Kuopio University Hospital, Kuopio, Finland
43Department of Hematology and Oncology, Georg-August-Universitaet Goettingen, Göttingen, Germany
44Institute for Medical Informatics, Statistics and Epidemiology (IMISE), University of Leipzig, Leipzig, Germany

Background

The ACT trial (ACT-1, younger patients aged 18-60 yrs and ACT-2, elderly patients aged >60 yrs) is the first international randomized phase III trial in newly diagnosed primary systemic peripheral T-cell lymphoma (PTCL). It tests, in both younger and elderly patients, the efficacy of the addition of alemtuzumab (ALZ) to 6 courses of bi-weekly CHOP followed, only in younger patients (ACT-1), by high-dose therapy with autologous stem cell rescue.  A dose reduction amendment tapering the cumulative ALZ dose from 360 mg (30 mg on days 1 and 2 of  CHOP courses 1-6) to 120 mg (30 mg on day 1 of CHOP courses 1-4), respectively, was introduced early on due to two cases of systemic fungal infection (Blood 2011,118;4110). To date, the trial has accrued a total of 186 patients (ACT-1 n=98; ACT-2 n=88).

Aim

Here, we present the results from the first interim efficacy and safety analysis of the ACT-1 trial based on the first 68 randomized patients.

Results

Of the 68 patients, 63 had a complete set of treatment data. The median follow-up was 15 months (range 0.5-42 months). Thirty-two patients belonged to the experimental arm (exp) and 31 to the standard arm (std). Of the 32 patients treated according to exp, 4 received the higher dose of ALZ and 28 the lower. Treatment arms were well balanced with regard to main prognostic features such as age (std: median 53 yrs, range 21-60 yrs; exp: median 50 yrs, range 22-64 yrs; p=0.705), IPI subgroups (std: low 10%, low-intermediate 51%, intermediate-high 29%, high 10%; exp: low 12%, low-intermediate 44%, intermediate-high 19%, high 25%; p=0.392), advanced clinical stage (std: stage III-IV 94%; exp: 97%; p=0.613), performance status ECOG>1 (std: 23%; exp: 28%; p=0.613), elevated LDH (std: 68%; exp: 69%; p=0.932), presence of B-symptoms (std: 68%; exp: 75%; p=0.524), bulky disease (std: 13%; exp: 13%; p=1.0) and bone marrow involvement (std: 39%; exp: 31%; p=0.535). Histological subtypes were also similarly distributed among both treatment arms (std: PTCL-NOS 55%, AILT 23%, other 22%; exp: PTCL-NOS 56%, AILT 28%, other 16%). No cases of anaplastic large cell PTCL (regardless of ALK-protein status) were included. Neither of the treatment cohorts showed significant treatment delay. The median duration of chemotherapy (calculated for 5 bi-weekly cycles of an expected cumulative duration of 70 days) for non-ALZ vs. ALZ-treated patients was 73 vs. 81 days, respectively. No suspected unexpected serious adverse reactions (SUSARs) were reported. Grade 4 leucopenia was more frequent in ALZ-treated patients (std: 24%, exp: 69%; p=0,001), whereas grade 3-4 anemia and grade 3-4 thrombocytopenia were not significantly different between treatment arms (anemia, std: 19%, exp: 31%; p=0,278; thrombocytopenia, std: 20%, exp: 12%, p=0,682) . Non-hematological toxicity unrelated to infectious complications was mild and had a similar frequency in both arms. The number of serious adverse events (SAEs) per patient was 0.86 for patients treated at post-amendment ALZ dose levels, representing a significant reduction compared to the pre-amendment value (3.25), and 0.46 for patients treated in the control arm (p=0.002). The frequency of bacterial and fungal infections (grade ≥3) was similar in both treatment arms. ALZ treated patients had more viral events (9/32; 28% vs. 3/31; 10%), mainly (6 out of 9) consisting of asymptomatic cytomegalovirus reactivations. The overall (non-arm specific) 1-year event-free survival (primary end-point), progression-free survival and overall survival were 55% (95% CI: 42%-67%), 54% (95% CI: 42%-67%) and 78% (95% CI: 67%-88%), respectively.

Conclusion

The safety profile of the current standard and experimental treatment schedules, as well as the interim outcome results, support a continuation of the trial. A final analysis will be performed in Q2 2015.

Disclosures: d'Amore: Sanofi: Research Funding; Amgen: Research Funding. Jantunen: Genzyme: Has participated in EU Leadership meeting organized by Genzyme as well as Medical Advisory Board meeting organized by Genzyme Other, Honoraria.


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