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

OBINUTUZUMAB WITH DHAP DID NOT IMPAIR PERIPHERAL STEM CELL HARVEST: RESULTS OF THE PHASE II PROSPECTIVE FIL GIOTTO TRIAL.
Author(s): ,
Luigi Rigacci
Affiliations:
Haematology,AOU Careggi,Firenze,Italy
,
Benedetta Puccini
Affiliations:
Haematology,AOU Careggi,Firenze,Italy
,
Carlo Visco
Affiliations:
Cell Therapy and Hematology,San Bortolo Hospital,Vicenza,Italy
,
Roberta Battistini
Affiliations:
Hematology,AO San Camillo Forlanini,Roma,Italy
,
Luca Arcaini
Affiliations:
Molecular Medicine and Hematology Division ,University of Pavia and IRCCS Policlinico S Matteo,Pavia,Italy
,
Manuel Gotti
Affiliations:
Hematology Division, IRCCS Policlinico S Matteo,Pavia,Italy
,
Francesca Elice
Affiliations:
Cell Therapy and Hematology,San Bortolo Hospital,Vicenza,Italy
,
Sofia Kovalchuk
Affiliations:
Haematology,AOU Careggi,Firenze,Italy
,
Michael Mian
Affiliations:
Hematology-CBMT and Internal Medicine V, Hematology and Oncology,Hospital of Bolzano and Medical University of Innsbruck,Bolzano,Italy
,
Alice Di Rocco
Affiliations:
Hematology,University La Sapienza,Roma,Italy
,
Leonardo Flenghi
Affiliations:
Hematology,Azienda Ospedaliera,Perugia,Italy
,
Samantha Pozzi
Affiliations:
Hematology,Medicina Diagnostica Clinica,Modena,Italy
,
Francesca Palombi
Affiliations:
Hematology,IFO Regina Elena,Roma,Italy
,
Piera Viero
Affiliations:
Hematology,Ospedale dell'Angelo,Venezia-Mestre,Italy
,
Andrea Evangelista
Affiliations:
Epidemiology ,Unit of Clinical Epidemiology and CPO Piemonte,Torino,Italy
Daniela Gioia
Affiliations:
Clinical Trial,Fondazione Italiana Linfomi,Alessandria,Italy
(Abstract release date: 05/17/18) EHA Library. Rigacci L. 06/14/18; 216667; PB2486
Dr. Luigi Rigacci
Dr. Luigi Rigacci
Contributions
Abstract

Abstract: PB2486

Type: Publication Only

Background
Salvage immune-chemotherapy followed by autologous stem cell transplantation (ASCT) is the standard second line treatment for relapsed and refractory Diffuse Large B Cell Lymphoma (DLBCL). Second line immune-chemotherapy, rituximab plus platinum compound or rituximab plus ifosfamide containing regimens, were able to obtain response and permit sufficient harvest of peripheral stem cell.

Aims
The aim of this phase II study (GIOTTO study, Eudract: 2013-004014-17) was to evaluate the efficacy and safety of new anti-CD20 antibody (Obinutuzumab) in association with DHAP as induction therapy before high dose chemotherapy with ASCT in patients with relapsed/refractory DLBCL.  One of the secondary objective of this study was to demonstrate the capacity of hematopoietic cell mobilization of this new immune-chemotherapic regimen.

Methods

Obinutuzumab was administered on day 1,8,15 in association with DHAP in the first cycle and on day 1 in association with DHAP for the other three cycles. Peripheral stem cell collection (PBSCC) had to be performed after the second or third cycle between 12 and 14 days.

Results

From June 2014 to June 2017 29 patients were enrolled, according to clinical characteristics 17 patients were refractory to first line therapy and 12 relapsed after first line treatment. Seventeen patients underwent peripheral blood stem cell (PBSC) mobilization while 12 did not because of disease progression during salvage therapy. Eight out 17 underwent PBSCC after the second cycle and 9 after third cycle. The median number of harvested CD34 positive cells was 5,8x106/Kg (range 2-12,24x106/Kg) and the median number of aphereses was 2 (range 1-4). No patients needed plerixafor administration.

Eight patients were transplanted with a median number of 3,85x106/Kg CD34 positive cells and no engraftment failures were reported. 

Conclusion
The use of Obinutuzumab did not impair peripheral stem cell harvest after salvage therapy in relapsed/refractory non Hodgkin’s lymphoma.

Session topic: 22. Stem cell transplantation - Experimental

Keyword(s): antibody, lymphoma, Mobilization

Abstract: PB2486

Type: Publication Only

Background
Salvage immune-chemotherapy followed by autologous stem cell transplantation (ASCT) is the standard second line treatment for relapsed and refractory Diffuse Large B Cell Lymphoma (DLBCL). Second line immune-chemotherapy, rituximab plus platinum compound or rituximab plus ifosfamide containing regimens, were able to obtain response and permit sufficient harvest of peripheral stem cell.

Aims
The aim of this phase II study (GIOTTO study, Eudract: 2013-004014-17) was to evaluate the efficacy and safety of new anti-CD20 antibody (Obinutuzumab) in association with DHAP as induction therapy before high dose chemotherapy with ASCT in patients with relapsed/refractory DLBCL.  One of the secondary objective of this study was to demonstrate the capacity of hematopoietic cell mobilization of this new immune-chemotherapic regimen.

Methods

Obinutuzumab was administered on day 1,8,15 in association with DHAP in the first cycle and on day 1 in association with DHAP for the other three cycles. Peripheral stem cell collection (PBSCC) had to be performed after the second or third cycle between 12 and 14 days.

Results

From June 2014 to June 2017 29 patients were enrolled, according to clinical characteristics 17 patients were refractory to first line therapy and 12 relapsed after first line treatment. Seventeen patients underwent peripheral blood stem cell (PBSC) mobilization while 12 did not because of disease progression during salvage therapy. Eight out 17 underwent PBSCC after the second cycle and 9 after third cycle. The median number of harvested CD34 positive cells was 5,8x106/Kg (range 2-12,24x106/Kg) and the median number of aphereses was 2 (range 1-4). No patients needed plerixafor administration.

Eight patients were transplanted with a median number of 3,85x106/Kg CD34 positive cells and no engraftment failures were reported. 

Conclusion
The use of Obinutuzumab did not impair peripheral stem cell harvest after salvage therapy in relapsed/refractory non Hodgkin’s lymphoma.

Session topic: 22. Stem cell transplantation - Experimental

Keyword(s): antibody, lymphoma, Mobilization

By clicking “Accept Terms & all Cookies” or by continuing to browse, you agree to the storing of third-party cookies on your device to enhance your user experience and agree to the user terms and conditions of this learning management system (LMS).

Cookie Settings
Accept Terms & all Cookies