Clinical-biological Characteristics and Outcome of Chronic Lymphocytic Leukemia Under Ibrutinib-named Patient Program
A Retrospective Study to Evaluate the Clinical-Biologic Characteristics and Outcome of Patients Treated in Italy According to the Ibrutinib-Named Patient Program for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
1 other identifier
observational
264
1 country
47
Brief Summary
This is a retrospective observational study aimed at describing the characteristics and outcome of CLL patients included in the NPP in Italy in a period of time ranging from the start of the NPP until November, 30th 2014. A longitudinal survey will be carried out by collecting data of patients who received at least 1 dose of Ibrutinib. All patients will be observed for at least 12 months from the treatment start.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2016
Typical duration for all trials
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2015
CompletedFirst Posted
Study publicly available on registry
October 21, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 3, 2018
CompletedSeptember 13, 2021
September 1, 2021
2.6 years
October 15, 2015
September 6, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients who progress
At 12 months from the start of Ibrutinib
Secondary Outcomes (9)
Number of patients who respond to treatment
At 12 months from enrolment
Treatment duration
At 12 months from enrolment
Time to next treatment in terms of number of days needed
At 12 months from treatment start
Number of patients surviving
At 12 months from treatment start
Number of patients who reach normal values in the immunoglobulin levels
At 3, 6 and 12 months from treatment start
- +4 more secondary outcomes
Study Arms (1)
Study patients
Patients with Relapsed or refractory CLL or 17p deleted CLL fulfilling the eligibility criteria required by the Named Patient Program (NPP) who received at least 1 dose of Ibrutinib 420 mg daily before November, 30th 2014.
Interventions
A longitudinal survey will be carried out by collecting data of patients who received at least 1 dose of Ibrutinib. All patients will be observed for at least 12 months from the treatment start.
Eligibility Criteria
Patients with R/R CLL or 17p deleted CLL fulfilling the eligibility criteria required by the NPP who received at least 1 dose of Ibrutinib 420 mg daily before November, 30th 2014
You may qualify if:
- Patients ≥18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- A minimum of one prior line of systemic chemotherapy, chemo-immunotherapy, or an alemtuzumab-based regimen, consisting of at least two cycles of therapy.
- Relapsed or refractory CLL with one or more of the following criteria:
- Presence of deletion of the short-arm of chromosome 17 (ie 17p deletion).
- Relapsed: Failed two or more previous treatments, at least one with a purine analogue such as fludarabine.
- Relapsed: Progression-free interval of less than 24 months from completing treatment with a nucleoside analogue, or bendamustine-containing regimen in combination with an anti-CD20 monoclonal antibody such as rituximab.
- Refractory: Failure to respond to a prior chemotherapy-based treatment, stable disease, or disease progression while on treatment.
- Patient has active CLL requiring treatment as defined by the IWCLL 2008 criteria. A minimum of one of the following criteria is required:
- Evidence of progressive marrow failure, as manifested by the development of, or worsening of, anemia or thrombocytopenia.
- Massive (at least 6 cm below the left costal margin), progressive, or symptomatic splenomegaly.
- c. Massive nodes (at least 10 cm in longest diameter), progressive, or symptomatic lymphadenopathy.
- Progressive lymphocytosis with an increase of more than 50% over a 2-month period or a lymphocyte doubling time of less than 6 months (which may be extrapolated). For patients with initial blood lymphocyte counts of less than 30 x 109/L (30,000/mL), lymphocyte doubling time should not be used as a single parameter to define indication for treatment. Factors contributing to lymphocytosis or lymphadenopathy other than CLL (e.g., infections) should be excluded.
- Constitutional symptoms, defined as 1 or more of the following disease-related symptoms or signs:
- i. Unintentional weight loss \>10% within the previous 6 months prior to screening.
- +12 more criteria
You may not qualify if:
- Previous treatment with ibrutinib or participation to an ibrutinib clinical trial (ibrutinib or comparator arm).
- Eligible to participate in a currently recruiting ibrutinib clinical trial.
- Previously received ibrutinib as part of a clinical trial.
- Previously received a Bruton's tyrosine kinase (BTK) inhibitor other than ibrutinib.
- Currently enrolled in an interventional clinical trial.
- Currently receiving chemotherapy, anticancer immunotherapy, or experimental therapy.
- Currently recovering from acute toxicities of prior treatment for CLL.
- Received stem cell transplantation within the past 6 months.
- Evidence of graft-versus-host disease and/or requires immunosuppressant therapy.
- Major surgery within the past 4 weeks or a major wound that has not fully healed.
- History of human immunodeficiency virus (HIV) or active infection with Hepatitis C or B.
- Ongoing uncontrolled active systemic infection.
- Uncontrolled autoimmune haemolytic anemia (AIHA).
- Uncontrolled idiopathic thrombocytopenic purpura (ITP).
- Central nervous system leukemia/lymphoma or Richter's transformation.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
U.O.C. Ematologia e Terapia Cellulare - Ospedale "C. e G. Mazzoni" di Ascoli Piceno
Ascoli Piceno, Italy
U.O.C di Ematologia P.O. "S.Giuseppe Moscati" - 2° piano
Aversa, Italy
UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
Bari, Italy
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
Bologna, Italy
Spedali Civili - Brescia - Azienda Ospedaliera - U.O. Ematologia
Brescia, Italy
Divisione di Ematologia Ospedale A. Perrino
Brindisi, Italy
ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
Cagliari, Italy
US Dipartimentale - Centro per le malattie del sangue - Ospedale Civile - S.Giacomo
Castelfranco Veneto, Italy
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
Catanzaro, Italy
U.O. di Medicina Interna - ASUR Marche 8 - Ospedale Civile
Civitanova Marche, Italy
Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
Cona, Italy
Unità di Ricerca e di Malattie del sangue - Ematologia San Luca Vecchio Pad. 16 - 1° Piano
Florence, Italy
IRCCS_AOU San Martino-IST.Clinica Ematologica
Genova, Italy
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
Lecce, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano
Milan, Italy
Ospedale Niguarda " Ca Granda" - SC Ematologia Blocco SUD, Ponti Est, Scala E, 4° piano
Milan, Italy
U.O. Ematologia e Trapianto di MIdollo - Ist.Scientifico Ospedale San Raffaele
Milan, Italy
Unità Trapianto di Midollo Ist. Nazionale Tumori
Milan, Italy
UO Ematologia - AOU Policlinico di Modena
Modena, Italy
Ospedale San Gennaro - ASL Napoli 1
Napoli, Italy
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
Novara di Sicilia, Italy
Università degli Studi di Padova - Ematologia ed Immunologia Clinica
Padua, Italy
U.O. di Oncoematologia di Nocera Inferiore-plesso ospedaliero "A. Tortora" di Pagani del DEA Nocera-Pagani
Pagani, Italy
Cattedra di Ematologia CTMO Università degli Studi di Parma
Parma, Italy
S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo
Pavia, Italy
Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della Misericordia
Perugia, Italy
U.O. Ematologia Clinica - Azienda USL di Pescara
Pescara, Italy
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto
Piacenza, Italy
Ematologia - Ospedale San Carlo
Potenza, Italy
Dipartimento Oncologico - Ospedale S.Maria delle Croci
Ravenna, Italy
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
Reggio Calabria, Italy
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
Reggio Emilia, Italy
Ospedale "Infermi"
Rimini, Italy
U.O.C. Ematologia - IRCCS Centro oncologico della Basilicata
Rionero in Vulture, Italy
S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena
Roma, Italy
U.O.C. Ematologia - Ospedale S.Eugenio
Roma, Italy
U.O.S.A. Ematologia ASL RMA Presidio Nuovo Regina Margherita
Roma, Italy
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma, Italy
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
Roma, Italy
Policlinico Umberto I, Hematology Department - Sapienza
Rome, Italy
Sezione di Ematologia Cancer Center Humanitas
Rozzano, Italy
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
Siena, Italy
A.O. Santa Maria - Terni S.C Oncoematologia
Terni, Italy
Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
Torino, Italy
Divisione di Ematologia dell' Università degli Studi di Torino - "Città della Salute e della Scienza di Torino"
Torino, Italy
ULSS N.6 Osp. S. Bortolo
Vicenza, Italy
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Roberto Foà
Policlinico Umberto I, Hematology Department.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2015
First Posted
October 21, 2015
Study Start
March 1, 2016
Primary Completion
October 1, 2018
Study Completion
October 3, 2018
Last Updated
September 13, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share