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Long‐term data of chronic lymphocytic leukemia (CLL) patients with favorable risk who were treated with fludarabine, cyclophosphamide, and rituximab (FCR) within clinical trials show good efficacy. We here report long‐term data collected within the GCLLSG registry. Altogether, 417 CLL patients who received first‐line treatment with FCR were analyzed, of which 293 (70.3%) were treated outside of clinical trials. The median observation time from first‐line was 95.8 (interquartile range 58.7–126.8) months. Focusing on data of 194 (46.5%) patients who received FCR first‐line treatment after 2013 (start of data collection within GCLLSG registry), responses were documented in 85% of the patients, non‐responses in 15%, and for 3.6% the assessment was missing. Median event‐free survival (EFS, time until disease progression, subsequent treatment, or death) was 60.2 months with a 5‐year EFS‐rate of 50.6%. Patients with higher‐risk disease, characterized by unmutated IGHV (N = 78), had a median EFS of 45.4 months with a 5‐year EFS rate of 36.3%, while the median EFS was 77.5 months with a 5‐year EFS rate of 60.3% in patients with mutated IGHV (N = 40). Median overall survival was not reached with a 5‐year survival rate of 92.7%. In summary, first‐line FCR was associated with long EFS, especially in patients exhibiting a mutated IGHV status. [ABSTRACT FROM AUTHOR]

Introduction: In patients with a clinical indication for autologous hematopoietic stem cell transplantation (ASCT), sufficient mobilization of CD34 + precursor cells into peripheral blood is essential to ensure adequate hematopoietic stem cell (HSC) collection prior to intensive therapy. However, with standard granulocyte-colony stimulating factor (G-CSF)-based mobilization schemes, an important minority of patients fail to mobilize sufficient (e.g., >10/µL) CD34 + cell counts into the peripheral blood and are considered as poor mobilizers (PM). Because failure to achieve sufficient CD34 + cell mobilization can negatively affect important clinical treatment endpoints, the use of plerixafor (PLX) was approved to increase CD34 + mobilization in PM patients., Methods: The German non-interventional, multicenter, open-label, prospective OPTIMOB study evaluated HSC mobilization strategies prior to planned ASCT in adult patients with hematologic malignancies (lymphomas or multiple myeloma [MM]) focusing on PM patients. PM patients were defined as follows: (1) never achieving ≥20 CD34 + cells/µL before 1st apheresis, (2) receiving PLX at any timepoint of mobilization, (3) their initially planned stem cell yield had to be reduced, or (4) they had not received apheresis due to low CD34 + count in peripheral blood., Results: 168 of 475 MM patients (35%) participating in the OPTIMOB study were classified as PM, and 155 of them (92%) received PLX (PM+PLX) during the study. PM patients were 40-78 years old, slightly more often male ( n = 97, 58%), mostly newly diagnosed ( n = 146, 87%) and received highly individualized previous treatments. Ninety-four of the PMs underwent chemotherapy mobilization (65%), and 51 patients (35%) received steady-state mobilization with G-CSF only during 1st mobilization attempt. 92% of the total PM population ( n = 155) underwent apheresis, 78% of them ( n = 117) achieved >2.0 × 10 6 CD34 + cells/kg body weight on the 1st day of apheresis. PM+PLX had a higher median total collection result than those PM patients without PLX support (7.2 vs. 5.7 × 10 6 CD34 + cells/kg body weight). In total, ASCT was performed in 136 PM+PLX (88%) versus 8 PM-PLX patients (62%)., Conclusion: The OPTIMOB study showed that a considerable proportion of adult MM patients in Germany are PMs. Even though most of PMs were supported with PLX in the OPTIMOB study, PM-PLX also successfully mobilized HSCs, allowing ASCT in majority of all PMs. However, further analyses are required for treatment optimization in PMs., Competing Interests: M.B. received honoraria for advisory board and consultancy activities from Bristol-Myers Squibb, Sanofi-Aventis Deutschland GmbH, and GlaxoSmithKline GmbH & Co. KG; research funding from Bristol-Myers Squibb (Celgene), Otsuka Pharmaceuticals, Sanofi, Chugai Pharma, AbbVie, AMGEN, and Janssen; and owns shares from AbbVie. K.K. received research funding from Bristol-Myers Squibb and Sanofi-Aventis Deutschland GmbH. C.T.S. received honoraria from Sanofi. M.G. (Matthias Grube) received honoraria from Sanofi, Janssen, and Bayer. V.V. received honoraria from Sanofi, Bristol-Myers Squibb, Novartis, Amgen, and Janssen. D.W. received honoraria for advisory board activities and travel support from Sanofi. A.B. received honoraria from Incyte and AOP Orphan and scientific support from AOP Orphan. M.S.H. received honoraria for consultancy activities from Celgene GmbH, Amgen GmbH, Kite/Pharma Gilead, Sanofi-Aventis Deutschland GmbH, GlaxoSmithKline GmbH & Co. KG, Bristol-Myers Squibb GmbH & Co. KG, Shionogi GmbH, and Stemline Therapeutics (no individual payment) and financial support of educational meetings from Janssen-Cilag GmbH, Takeda Pharma Vertrieb GmbH & Co. KG, Novartis Pharma GmbH, Pfizer Pharma GmbH, Roche Pharma AG, Vifor Pharma Deutschland GmbH, and Celgene GmbH (no individual payment). Additionally, M.S.H. participated in different clinical trials supported by the industry (including the OPTIMOB study). C. K. (Christoph Kimmich) received honoraria from Amgen, Janssen, Kite/Pharma Gilead, Takeda, GlaxoSmithKline GmbH & Co., and Sanofi-Aventis Deutschland GmbH, as well as travel support from Janssen and Kite/Pharma Gilead. M.H. received lecture fees from Amgen, AstraZeneca, Eusa Pharma, Celgene, Janssen, Jazz Pharma, and Takeda, and served on advisory boards of Amgen, Eusa Pharma, Janssen, and Sanofi. C.K. (Christian Kunz) received honoraria for advisory board activities from AbbVie, Sanofi, Bristol-Myers Squibb, and Amgen, as well as financial support for congress participation from AbbVie, Amgen, and Bristol-Meyer Squibb. C.K. (Cyrus Khandanpour) received honoraria and research funding from Sanofi, Bristol-Myers Squibb, AstraZeneca, Novartis, Amgen, and Janssen. M.W. received honoraria for lectures from AstraZeneca, Novartis, Ispen, Roche, Janssen, Sanofi, Medac, Takeda, and Pierre Fabre; travel support from AstraZeneca, AbbVie, and Pfizer; and research funding from AstraZeneca, Bristol-Myers Squibb, Novartis, Pfizer, Roche, Janssen, Takeda, MSD, Boehringer, Pierre Fabre, Amgen, Genzyme, and MorphoSys. U.H. received honoraria from Sanofi and Amgen. R.N. received honoraria for consultancy activities from AvenCell (formerly Cellex Patient Treatment GmbH), Simon Kucher & Partners Strategy & Marketing Consultants GmbH, and Takeda; honoraria for advisory board activities from Sanofi-Aventis Deutschland GmbH, Glaxo Smith Kline GmbH & Co. KG, Oncopeptides, Bristol-Myers Squibb (Celgene), Janssen, Gilead, and Amgen; honoraria for lectures from Forum Medizin Fortbildung (FOMF) and Bildungsinstitut für Gesundheitsberufe Südwestfalen in Siegen (BIGS) GmbH; and honoraria for authorship from Elsevier. C.W.S. received honoraria from Bristol-Myers Squibb, Celgene, Daiichi Sankyo, GILEAD, Hexal, Incyte, Janssen, Lilly, MSD, Merck Serono, Miltenyi Biotec, Novartis, Pfizer, Roche, and Takeda. H.J.T. received honoraria from Sanofi, Bristol-Myers Squibb, and Takeda. F.B. and M.E. are employed by Sanofi-Aventis Deutschland GmbH and may hold stock and/or stock options in the company. N.K. received honoraria and research funding from Sanofi, Bristol-Myers Squibb, Neovii, Novartis, Amgen, and Riemser. A.K., K.M., A.S., M.G. (Martin Görner), F.H., H.A.D., A.R., B.M., and M.K. have no conflicts of interest to declare., (© 2023 The Author(s). Published by S. Karger AG, Basel.)

Introduction: Successful mobilization and collection of peripheral hematopoietic stem cells (HSCs) are necessary for lymphoma patients eligible for myeloablative chemotherapy with subsequent autologous stem cell transplantation (ASCT). Albeit G-CSF alone or combined with chemotherapy is well-established methods for HSC mobilization, up to 40% of the patients fail to mobilize (poor mobilizer, PM). Plerixafor (PLX) is commonly used in PM patients resulting in increased migration of HSCs into peripheral blood and thus improves the collection outcome., Methods: The prospective, multicenter, open-label, non-interventional OPTIMOB study assessed mobilization and collection parameter of patients with lymphoma or multiple myeloma to get deep insights in the treatment of those patients in clinical routine focusing on PM patients. PM was defined as follows: (1) no achievement of ≥20 CD34 + progenitor cells/µL before first apheresis, (2) PLX administration at any time point during the observational period, (3) reduction of the initially planned CD34 + progenitor cell yield as necessity due to failed mobilization or HSC collection, and (4) no performance of apheresis due to low CD34 + progenitor level. Primary objective of the study was to assess mobilization success by the proportion of PM patients achieving >2 × 10 6 CD34 + progenitor cells/kg body weight on the first day of apheresis. Here, the data of the lymphoma cohort are presented., Results: Out of 238 patients with lymphoma documented in the study, 32% were classified as PM. 87% of them received PLX. Demographic data revealed no obvious differences between PM and good mobilizing (GM) patients. All patients were treated highly individualized prior to mobilization. Majority of all PM patients were able to undergo apheresis (95%) and reached their individual requested CD34 + progenitor cell target (72%). 57% of the PM patients achieved >2.0 × 10 6 CD34 + progenitor cells/kg body weight on day 1 of apheresis and nearby 70% of them underwent ASCT. Median time to engraftment was similar in PM and GM patients of the lymphoma cohort., Conclusions: Majority of PM patients with lymphoma were successfully mobilized and underwent ASCT. Most of them received PLX during the study., Competing Interests: K.K. received research funding from Bristol Myers Squibb and Sanofi-Aventis Deutschland GmbH. M.B. received honoraria for advisory board and consultancy activities from Bristol Myers Squibb, Sanofi-Aventis Deutschland GmbH, Glaxo Smith Kline GmbH & Co. KG, research funding from Bristol Myers Squibb (Celgene), Otsuka Pharmaceuticals, Sanofi, Chugai Pharma, Abbvie, AMGEN, and Janssen, and owns shares from Abbvie. S.S. received honoraria and research funding from Sanofi-Aventis Deutschland GmbH, Bristol Meyers Squibb, Amgen, and Janssen. C.T.-S. received honoraria from Sanofi. M.G. (Matthias Grube) received honoraria from Sanofi, Janssen, and Bayer. V.V. received honoraria from Sanofi, Bristol Myers Squibb, Novartis, Amgen, and Janssen. D.W. received honoraria for advisory board activities and travel support from Sanofi. A.B. received honoraria from Incyte and AOP Orphan and scientific support from AOP Orphan. M.S.-H. received honoraria for consultancy activities from Celgene GmbH, Amgen GmbH, Kite/Pharma Gilead, Sanofi-Aventis Deutschland GmbH, Glaxo Smith Kline GmbH & Co. KG, Bristol Myers Squibb GmbH & Co. KG, Shionogi GmbH, Stemline Therapeutics (no individual payment) and financial support of educational meetings from Janssen-Cilag GmbH, Takeda Pharma Vertrieb GmbH & Co. KG, Novartis Pharma GmbH, Pfizer Pharma GmbH, Roche Pharma AG, Vifor Pharma Deutschland GmbH, and Celgene GmbH (no individual payment). Additionally, M.S.-H. participated in different clinical trials supported by the industry (including the OPTIMOB study). C.K. (Christoph Kimmich) received honoraria from Amgen, Janssen, Kite/Pharma Gilead, Takeda, Glaxo Smith Kline GmbH & Co, and Sanofi-Aventis Deutschland GmbH as well as travel support from Janssen and Kite/Pharma Gilead. M.H. received lecture fees by Amgen, AstraZeneca, EusaPharma, Celgene, Janssen, Jazz Pharma, and Takeda, and served on advisory boards of Amgen, EusaPharma, Janssen, and Sanofi. C.K. (Christian Kunz) received honoraria for advisory board activities from Abbvie, Sanofi, Bristol Meyer Squibb, and Amgen as well as financial support for congress participation from Abbvie, Amgen, and Bristol Meyer Squibb. C.K. (Cyrus Khandanpour) received honoraria and research funding from Sanofi, Bristol Myers Squibb, AstraZeneca, Novartis, Amgen, and Janssen. M.W. received honoraria for lectures from AstraZeneca, Novartis, Ispen, Roche, Janssen, Sanofi, Medac, Takeda, and Pierre Fabre, travel support from AstraZeneca, Abbvie, and Pfizer, and research funding from AstraZeneca, Bristol Meyer Squibb, Novartis, Phizer, Roche, Janssen, Takeda, MSD; Boehringer, Pierre Fabre, Amgen, Genzyme, and MorphoSys. U.H. received honoraria from Sanofi and Amgen. R.N. received honoraria for consultancy activities from AvenCell (formerly Cellex Patient Treatment GmbH), Simon Kucher and Partners Strategy and Marketing Consultants GmbH, and Takeda, honoraria for advisory board activities from Sanofi-Aventis Deutschland GmbH, Glaxo Smith Kline GmbH & Co. KG, Oncopeptides, Bristol Myers Squibb (Celgene), Janssen, Gilead, Amgen, honoraria for lectures from Forum Medizin Fortbildung (FOMF), Bildungsinstitut für Gesundheitsberufe Südwestfalen in Siegen (BIGS) GmbH, and honoraria for authorship from Elsevier. C.W.S. received honoraria from Bristol Myers Squibb, Celgene, Daiichi Sankyo, GILEAD, Hexal, Incyte, Janssen, Lilly, MSD, Merck Serono, Miltenyi Biotec, Novartis, Pfizer, Roche, and Takeda. H.J.T. received honoraria from Sanofi, Bristol Meyer Squibb, and Takeda. F.B. and M.E. are Employed by Sanofi-Aventis Deutschland GmbH and May Hold Stock and/or Stock Options in the Company. N.K. received honoraria and research funding from Sanofi, Bristol Myers Squibb, Neovii, Novartis, Amgen, and Riemser. A.K., K.M., A.S., M.G. (Martin Görner), F.H., H.A.D., A.R., B.M., and M.K. have no conflicts of interest to declare., (© 2023 The Author(s). Published by S. Karger AG, Basel.)

Cure rates in adult acute lymphoblastic leukemia (ALL) improved using pediatric-based chemotherapy and stem cell transplantation (SCT). However, limited data on the health condition of cured adults are available whereas pediatric data cannot be transferred. The GMALL analyzed the health status in survivors of adult ALL retrospectively. Physicians answered a questionnaire on general condition (Eastern Cooperative Oncology Group [ECOG] status) and comorbidity or syndrome occurrence observed after treatment. Five hundred and thirty-eight patients with a median age of 29 (range, 15-64) years at diagnosis were analyzed, median follow-up was 7 (range, 3-24) years. Thirty-one percent had received SCT. ECOG status was 0-1 in 94%, 34% had not developed significant comorbidities. Most frequent comorbidities involved the neurologic system (27%), endocrine system (20%), skin (18%), graft-versus-host-disease (15%), cardiac system (13%), fatigue (13%). SCT impacted ECOG status and comorbidity occurrence significantly. ECOG 0-1 was observed in 86% of SCT and 98% of non-SCT patients (P<0.0001); comorbidity was observed in 87% and 57% respectively (P<0.0001). Our analysis elucidates the spectrum of comorbidities in cured adult ALL patients, with higher risk for transplanted patients, providing stimulations for the design of adequate aftercare programs. Overall, a large proportion of non-SCT patients achieved unrestricted general condition. The data provide a reference for new patient-centered endpoints in future trials.