EHA Library - The official digital education library of European Hematology Association (EHA)

TREATMENT OF CLL RELAPSED/REFRACTORY PATIENTS IN COVID-19 PANDEMIC: A REAL-LIFE EXPERIENCE WITH VENETOCLAX-RITUXIMAB COMBINATION IN SOUTHERN ITALY.
Author(s): ,
Stefano Molica
Affiliations:
Hematological Oncology,Azienda Ospedaliera Pugliese-Ciaccio, Catanzaro,Italy,Catanzaro,Italy
,
Paolo Sportoletti
Affiliations:
Hematological Oncology,Università degli studi,Perugia,Italy
,
Bruno Martino
Affiliations:
Hematology,Azienda Ospedaliera Bianchi-Melacrino,Reggio Calabria,Italy
,
Caterina Patti
Affiliations:
Hematology,A. O. Villa Sofia Cervello,Palermo,Italy
,
Giuseppe Mineo
Affiliations:
Hematology,Ospedale civile San Vincenzo T,aormina ME,Italy
,
Donato Mannina
Affiliations:
Hematology,A. O. Papardo,Messina,Italy
,
Vincenzo Leone
Affiliations:
Hematology,P.O. Vittorio Emanuele II , Castelvetrano TP,Italy
,
Maurizio Musso
Affiliations:
Hematology,Ist.diagnostico siciliano CDC La Maddalena,Palermo,Italy
,
Sergio Siragusa
Affiliations:
Hematology,A.O. Policlinico Giaccone,Palermo,Italy
,
Gaetano Palumbo
Affiliations:
Hematology,Ospedali Riuniti,Foggia,Italy
,
Viviana Minardi
Affiliations:
Hematology,P.O. Sant' Elia- ,Caltanissetta,Italy
,
Potito Scalzulli
Affiliations:
Hematology,Ospedale Casa Sollievo della sofferenza -,S.Giovanni Rotondo (FG),Italy
,
Giuseppe Tarantini
Affiliations:
Hematology,Ospedale Monsignor Dimiccoli- Barletta,Barletta,Italy
,
Alessandro Maggi
Affiliations:
Hematology,Ospedale Oncologico G. Moscati -,Taranto,Italy
,
Ilaria Angeletti
Affiliations:
Hematology,A.O. Santa Maria -,Terni,Italy
,
Antonino Greco
Affiliations:
Hematology,Ospedale Cardinale Panico,Tricase (LE),Italy
,
Luciano Levato
Affiliations:
Hematology,azienda ospedaliera Pugliese-Ciaccio,Catanzaro,Italy
,
Marco Rossi
Affiliations:
Hematology,Università Magna Graecia - Catanzaro,Catanzaro,Italy
,
Massimo Gentile
Affiliations:
Hematology,Ospedale Annunziata - Cosenza,Cosenza,Italy
,
Caterina Stelitano
Affiliations:
Hematology,Ospedale Bianchi Melacrino,Reggio Calabria,Italy
,
Catello Califano
Affiliations:
Hematology,Ospedale A.Tortora , Pagani - SA,Italy
,
Carmine Selleri
Affiliations:
Hematology,AOU OO.RRS.Giovanni di Dio e Ruggi -,Salerno,Italy
,
Angiola Rocino
Affiliations:
Hematology,Ospedale del mare centro di emofilia e trombosi -,Napoli,Italy
,
Antonio Maria Risitano
Affiliations:
Hematology,Azienda ospedaliera San Giuseppe Moscati,Avellino,Italy
,
Federico Chiurazzi
Affiliations:
Hematology,Azienda ospedaliera San Giuseppe Moscati UOC  ematologia -,Avellino,Italy
,
Giuliana Farina
Affiliations:
Hematology,AORN S Anna e S Sebastiano,Caserta,Italy
,
Anna Maria Giordano
Affiliations:
Hematology & Stem Cell Transplantation,Aldo Moro University,Bari,Italy
,
Anna Lisa Chiarenza
Affiliations:
Hematology,A.O.Policlinico Universitario Rodolico,Catania,Italy
,
Pellegrino Musto
Affiliations:
Hematology & Stem Cell Transplantation,University Aldo Moro,Bari,Italy
,
Nicola Di Renzo
Affiliations:
Hematology,Ospedale Vito Fazi,Lecce,Italy
,
Fabrizio Pane
Affiliations:
Hematology,Azienda Osp Universitaria Federico II -,Napoli,Italy
Francesco Di Raimondo
Affiliations:
Hematology,A.O.Policlinico Universitario Rodolico,Catania,Italy
EHA Library. molica s. 06/09/21; 325411; EP651
Dr. stefano molica
Dr. stefano molica
Contributions
Abstract
Presentation during EHA2021: All e-poster presentations will be made available as of Friday, June 11, 2021 (09:00 CEST) and will be accessible for on-demand viewing until August 15, 2021 on the Virtual Congress platform.

Abstract: EP651

Type: E-Poster Presentation

Session title: Chronic lymphocytic leukemia and related disorders - Clinical

Background
 Given the multifactorial immune defect characterizing chronic lymphocytic leukemia (CLL), it appears conceivable that these patients have risk factors that increase their likelihood of complications and death from COVID-19.

Aims

To evaluate  incidence and severity of COVID-19 cases in a well-defined cohort of patients with CLL receiving venetoclax-based combinations.  


 

Methods
We administered a survey to a cohort of CLL treating hematologists from  hematological centers in southern Italy. Participants were asked: a) to indicate whether they had offered a test for detection of COVID-19  infection (mainly nasopharyngeal swabs) only to CLL patients who reported symptoms or universallyb) to provide information on the incidence of COVID-19 infection and its severity; c) to specify reasons of possible treatment modifications.    The survey was restricted to relapsed-refractory (R/R) CLL patients treated from Feb 1st  to Dec 31th 2020 with time-limited venetoclax/rituximab (VR) combination  as recommended by MURANO protocol (venetoclax for up to 2 years plus rituximab for the first 6 months), within their clinical practice.

Results
A specific questionnaire was sent to 30 CLL hematologists, but only 26 responded to all questions. We considered suitable for the present analysis the 24 questionnaires compiled by hematologists who declared to have treated at least one patient with VR combination in the observation period. Of those, 20.8% worked in academic hospitals. Overall, the survey allowed to collect data on 124 patients who were treated with VR combination.   The median number of patients treated in each center was 5 (range,1-15).COVID-19 surveillance tests consisted of viral RNA reverse transcriptase PCR (RT-PCR) on nasopharyngeal swabs.  Generally, a policy of universal SARS-CoV-2 testing to be performed on  patients at different time-points of therapy was used.  Most patients (83/124, 66.9%) were tested before beginning the ramp-up with venetoclax;  moreover 66/124 (53.2%) were regularly tested before each rituximab infusion (Fig 1).Reasons for potential change of the schedule of treatment were also investigated. The survey revealed that adherence to treatment was relatively high (70.8%). Only 29.1% physicians modified the therapeutic program mainly because of grade 3 neutropenia.  Changes consisted of transient interruption of venetoclax, reduction of doses, and delay of rituximab infusion.Only 2/124 patients (1.6%) had a symptomatic RT-PCR proven diagnosis of COVID-19 infection and required hospitalization. Both patients  needed oxygen therapy and admission into an intensive care unit. Of those, 1 patient who was receiving VR combination at the time of COVID infection, eventually died. The second patient developed COVID-19 infection while receiving venetoclax monotherapy (after the VR combination period). He recovered from COVID-19 infection and after 21 days of treatment interruption, he was able to restart venetoclax.

Conclusion
Results of the present survey provide information, thus far lacking, on the use in real-world clinical practice of VR combination during the COVID19 pandemic in 2020.   Current literature on  the prevalence of COVID-19 infection in CLL, has some limitations (i.e., small size sample, heterogeneity of treatment, restriction to only the first pandemic wave); this survey, performed on a large number of CLL patients treated with VR combination only seems to provide  additional information on safe  management of CLL  treatment during the COVID19 pandemic.

 

Keyword(s): Chronic lymphocytic leukemia, COVID-19

Presentation during EHA2021: All e-poster presentations will be made available as of Friday, June 11, 2021 (09:00 CEST) and will be accessible for on-demand viewing until August 15, 2021 on the Virtual Congress platform.

Abstract: EP651

Type: E-Poster Presentation

Session title: Chronic lymphocytic leukemia and related disorders - Clinical

Background
 Given the multifactorial immune defect characterizing chronic lymphocytic leukemia (CLL), it appears conceivable that these patients have risk factors that increase their likelihood of complications and death from COVID-19.

Aims

To evaluate  incidence and severity of COVID-19 cases in a well-defined cohort of patients with CLL receiving venetoclax-based combinations.  


 

Methods
We administered a survey to a cohort of CLL treating hematologists from  hematological centers in southern Italy. Participants were asked: a) to indicate whether they had offered a test for detection of COVID-19  infection (mainly nasopharyngeal swabs) only to CLL patients who reported symptoms or universallyb) to provide information on the incidence of COVID-19 infection and its severity; c) to specify reasons of possible treatment modifications.    The survey was restricted to relapsed-refractory (R/R) CLL patients treated from Feb 1st  to Dec 31th 2020 with time-limited venetoclax/rituximab (VR) combination  as recommended by MURANO protocol (venetoclax for up to 2 years plus rituximab for the first 6 months), within their clinical practice.

Results
A specific questionnaire was sent to 30 CLL hematologists, but only 26 responded to all questions. We considered suitable for the present analysis the 24 questionnaires compiled by hematologists who declared to have treated at least one patient with VR combination in the observation period. Of those, 20.8% worked in academic hospitals. Overall, the survey allowed to collect data on 124 patients who were treated with VR combination.   The median number of patients treated in each center was 5 (range,1-15).COVID-19 surveillance tests consisted of viral RNA reverse transcriptase PCR (RT-PCR) on nasopharyngeal swabs.  Generally, a policy of universal SARS-CoV-2 testing to be performed on  patients at different time-points of therapy was used.  Most patients (83/124, 66.9%) were tested before beginning the ramp-up with venetoclax;  moreover 66/124 (53.2%) were regularly tested before each rituximab infusion (Fig 1).Reasons for potential change of the schedule of treatment were also investigated. The survey revealed that adherence to treatment was relatively high (70.8%). Only 29.1% physicians modified the therapeutic program mainly because of grade 3 neutropenia.  Changes consisted of transient interruption of venetoclax, reduction of doses, and delay of rituximab infusion.Only 2/124 patients (1.6%) had a symptomatic RT-PCR proven diagnosis of COVID-19 infection and required hospitalization. Both patients  needed oxygen therapy and admission into an intensive care unit. Of those, 1 patient who was receiving VR combination at the time of COVID infection, eventually died. The second patient developed COVID-19 infection while receiving venetoclax monotherapy (after the VR combination period). He recovered from COVID-19 infection and after 21 days of treatment interruption, he was able to restart venetoclax.

Conclusion
Results of the present survey provide information, thus far lacking, on the use in real-world clinical practice of VR combination during the COVID19 pandemic in 2020.   Current literature on  the prevalence of COVID-19 infection in CLL, has some limitations (i.e., small size sample, heterogeneity of treatment, restriction to only the first pandemic wave); this survey, performed on a large number of CLL patients treated with VR combination only seems to provide  additional information on safe  management of CLL  treatment during the COVID19 pandemic.

 

Keyword(s): Chronic lymphocytic leukemia, COVID-19

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