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Phase 2 Study to Assess Activity & Safety of Front-line Ibrutinib + Rituximab in Unfit Chronic Lymphocytic Leukemia (LLC1114)

Primary Purpose

Chronic Lymphocyte Leukemia, Adult Patients

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Ibrutinib
Rituximab
Sponsored by
Gruppo Italiano Malattie EMatologiche dell'Adulto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocyte Leukemia focused on measuring Chronic lymphocyte leukemia, Adults, Ibrutinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 years of age or older.
  2. Diagnosis of CLL meeting IWCLL criteria.
  3. The diagnosis of CLL requires a history of lymphocytosis with a B-lymphocyte count ≥5,000/μL. Prolymphocytes may comprise no more than 55% of blood lymphocytes.
  4. Active disease meeting at least 1 of the following IWCLL 2008 criteria for requiring treatment:

    1. Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia or thrombocytopenia.
    2. Massive (ie, at least 6 cm below the left costal margin), progressive, or symptomatic splenomegaly.
    3. Massive nodes (ie, at least 10 cm in longest diameter), progressive, or symptomatic lymphadenopathy.
    4. Progressive lymphocytosis with an increase of more than 50% over a 2-month period or a lymphocyte doubling time (LDT) of less than 6 months (which may be extrapolated). Lymphocyte doubling time can be obtained by linear regression extrapolation of ALCs obtained at intervals of 2 weeks over an observation period of 2 to 3 months. For patients with initial blood lymphocyte counts of less than 30 x 109/L (30,000/μL), LDT should not be used as a single parameter to define indication for treatment. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL (eg, infections) should be excluded.
    5. Constitutional symptoms, defined as 1 or more of the following disease-related symptoms or signs:

      • Unintentional weight loss >10% within the previous 6 months prior to screening
      • Significant fatigue (inability to work or perform usual activities)
      • Fevers higher than 38.0°C for 2 or more weeks without evidence of infection; or
      • Night sweats for more than 1 month without evidence of infection
      • Measurable nodal disease by computed tomography (CT). Measurable nodal disease is defined as at least one lymph node >1.5 cm in longest diameter in a site that has not been previously irradiated. An irradiated lesion may be assessed for measurable disease only if there has been documented progression in that lesion since radiotherapy has ended.
  5. No prior treatment.
  6. Total CIRS >6 and/or creatinine clearance <70 ml/min [Cockcroft-Gault]).
  7. Hematology values within the following limits: Absolute neutrophil count (ANC) ≥1 x 109/L (ie, ≥1000/μL) independent of growth factor support. Platelets ≥50,000/mm3 if bone marrow involvement independent of transfusion support
  8. Biochemical values within the following limits:

    1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN)
    2. Total bilirubin ≤1.5 x ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
    3. Serum creatinine ≤2 x ULN or estimated Glomerular Filtration Rate (Cockroft Gault) ≥40 mL/min
  9. Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree not to donate sperm during and after the study. For females, these restrictions apply for 1 month after the last dose of study drug. For males, these restrictions apply for 3 months after the last dose of study drug.
  10. Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [β-hCG]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study.
  11. A signed (or signed by their legally-acceptable representatives) informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study.

Exclusion Criteria:

  1. Any significant concurrent, uncontrolled medical condition or organ system dysfunction and/or laboratory abnormality or psychiatric disease which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk or prevent the subject from signing the informed consent form.
  2. Pregnant or lactating females
  3. Known presence of alcohol and/or drug abuse.
  4. Any potential subject who meets any of the following criteria will be excluded from participating in the study.
  5. Major surgery within 4weeks of randomization.
  6. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia.
  7. Known central nervous system lymphoma.
  8. History of stroke or intracranial hemorrhage within 6 months prior to randomization, or of a significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae.
  9. Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) in any moment of the study.
  10. Requires treatment with strong CYP3A inhibitors.
  11. Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association
  12. Vaccinated with live, attenuated vaccines within 4 weeks of randomization.
  13. Known history of human immunodeficiency virus (HIV) positive serology for HIV; active Hepatitis B Virus infection or positive serology for Hepatitis B (HBV) defined as a positive test for HBsAg and HBV-DNA; active Hepatitis C or HCV-RNA positive; any uncontrolled active systemic infection requiring intravenous (IV) antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection; history of tuberculosis within the last five years or recent exposure to tuberculosis equal to or less than 6 months.
  14. Richter's syndrome (RS), concomitant or past malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.

Sites / Locations

  • S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
  • U.O.C. Ematologia e Terapia Cellulare - Ospedale "C. e G. Mazzoni" di Ascoli Piceno
  • S.O.C. di Medicina Interna B - Ospedale - Cardinal Massaia di Asti
  • UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
  • Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
  • ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
  • U.O.C. di Onco-Ematologia - Centro di Ricerca e Formazione ad Alta tecnologia nelle Scienze Biomediche
  • Unità di Onco-Ematologia - Azienda Ospedaliera - Garibaldi
  • Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
  • Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
  • U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza
  • Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria
  • IRCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente
  • ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
  • Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST
  • Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
  • Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
  • Ospedale Niguarda " Ca Granda" - SC Ematologia Blocco SUD, Ponti Est, Scala E, 4° piano
  • UO Ematologia - AOU Policlinico di Modena
  • .C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro Gianluca Gaidano S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro Novara Davide Rossi S
  • Università degli Studi di Padova - Ematologia ed Immunologia Clinica
  • U.O. di Oncoematologia di Nocera Inferiore-plesso ospedaliero "A. Tortora" di Pagani del DEA Nocera-Pagani
  • Cattedra di Ematologia CTMO Università degli Studi di Parma
  • S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo
  • Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della Misericordia
  • U.O. Ematologia Clinica - Azienda USL di Pescara
  • Dipartimento Oncologico - Ospedale S.Maria delle Croci
  • Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
  • Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
  • Ospedale "Infermi"
  • Dipartimento di Biotecnologie Cellulari ed Ematologia - Università degli Studi "Sapienza" di Roma
  • Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
  • U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
  • A.O. Santa Maria - Terni S.C Oncoematologia
  • Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
  • Divisione di Ematologia dell' Università degli Studi di Torino - "Città della Salute e della Scienza di Torino"

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Ibrutinib (PCI-32765) 420 mg (3 x 140 mg capsules) will be administered orally once daily. The first dose will be delivered in the clinic on Day 1, after which subsequent dosing is typically on an outpatient basis. Treatment duration with Ibrutinib will be based on what comes first of the following three options: Treatment until progression or toxicity Treatment until MRD negativity for 6 months Treatment for 6 years. Rituximab 375 mg/m2 iv. Month 1: day 1 of weeks 1, 2, 3, 4; months 2-6: day 1of week 1.

Outcomes

Primary Outcome Measures

Number of patients on progression-free survival
To estimate Progression-Free Survival (PFS) at 12 months in patients treated with Ibrutinib plus Rituximab combination in unfit patients with CLL.

Secondary Outcome Measures

Number of patients in complete response (CR) or partial response (OR)
Rate of Overall Response Rate (ORR) measured in terms of number of patients in CR/PR at the end of induction therapy.
Number of patients in CR
Rate of Complete Responses (CR) measured in terms of number of patients in CR at the end of induction therapy.
Number of negative minimal residual disease CRs
Minimal Residual Disease (MRD) in terms of rate of MRD-negative CRs at the end of induction therapy.
Number of days from treatment discontinuation to new treatment restart.
Time To Next Treatment (TTNT) after treatment discontinuation.
Number of patients in event-free survival
Event-Free Survival (EFS) at 36 months.
Number of patients in overall survival (OS)
Overall Survival (OS) at 36 months.
Number of patients in which there is a hematological improvement
Rate of hematological improvement in patients with baseline anemia, neutropenia and thrombocytopenia defined by hemoglobin >11 g/dL or increase ≥50% over baseline, granulocyte >1500 mm3 or platelet count >100,000/mm3, respectively.
Number of patients with improvement in the immunoglobulin levels
Rate of patients with improvement in the immunoglobulin levels.
Number of adverse events and serious adverse events
Number of patients requiring hospitalization
Rate of patients requiring hospitalization, emergency department visits, blood product transfusions and use of hematopoietic growth factors.
Number of patients in which clinical and biological features can be linked
Rate of ORR, CR, PFS, EFS, TTNT and OS according to clinical and biologic variables: age, size of nodes, CIRS score, stage, ß2-microglobulin, lymphocyte count, stage, CD38, CD49d, ZAP-70, IGVH mutation status, FISH profile (11q del; 17p del; trisomy 12; 13q del; no aberrations) and mutations of TP53, NOTCH1, SF3B1 and BIRC3.
Number of leukemic subpopulations
Proportion of leukemic and of normal lymphocyte subpopulations, including evaluation of cytokine receptors/adhesion molecules on peripheral blood lymphocytes at week +2 from the start of treatment.
Number of patients with RS identified by FDG-PET/CT
Rate of cases of patients with RS or SM identified by FDG-PET/CT

Full Information

First Posted
September 2, 2014
Last Updated
October 5, 2020
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
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1. Study Identification

Unique Protocol Identification Number
NCT02232386
Brief Title
Phase 2 Study to Assess Activity & Safety of Front-line Ibrutinib + Rituximab in Unfit Chronic Lymphocytic Leukemia
Acronym
LLC1114
Official Title
A Phase 2 Multicenter Study to Assess the Activity and the Safety of Front-line Ibrutinib Plus Rituximab (IR) in Unfit Patients With Chronic Lymphocytic Leukemia (CLL).
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The present study aims at evaluating whether treatment with two different drugs, Ibrutinib and Rituximab is both efficient and safe for newly diagnosed patients with chronic lymphocytic leukemia.
Detailed Description
Given that: Ibrutinib as single agent has been associated with a high response rate and PFS in previously treated patients, and in patients with poor prognosis clinical and biologic features. Ibrutinib as single agent has proven activity and is associated with a good safety profile in elderly patients with CLL. The Ibrutinib plus Rituximab combination has been associated with a high response rate and PFS in previously treated patients, and in patients with poor prognosis clinical and biologic features. The combined administration of Ibrutinib and Rituximab could be an effective and safe front-line treatment schedule for unfit patients with CLL. The current study is designed to evaluate whether first line treatment with Ibrutinib and Rituximab results in a significant improvement in PFS at 12 months as compared with chlorambucil plus rituximab in patients unfit for fludarabine- or bendamustine-based treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocyte Leukemia, Adult Patients
Keywords
Chronic lymphocyte leukemia, Adults, Ibrutinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Ibrutinib (PCI-32765) 420 mg (3 x 140 mg capsules) will be administered orally once daily. The first dose will be delivered in the clinic on Day 1, after which subsequent dosing is typically on an outpatient basis. Treatment duration with Ibrutinib will be based on what comes first of the following three options: Treatment until progression or toxicity Treatment until MRD negativity for 6 months Treatment for 6 years. Rituximab 375 mg/m2 iv. Month 1: day 1 of weeks 1, 2, 3, 4; months 2-6: day 1of week 1.
Intervention Type
Drug
Intervention Name(s)
Ibrutinib
Intervention Description
Ibrutinib (PCI-32765) 420 mg (3 x 140 mg capsules) will be administered orally once daily. The first dose will be delivered in the clinic on Day 1, after which subsequent dosing is typically on an outpatient basis.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Rituximab 375 mg/m2 iv. Month 1: day 1 of weeks 1, 2, 3, 4; months 2-6: day 1of week 1.
Primary Outcome Measure Information:
Title
Number of patients on progression-free survival
Description
To estimate Progression-Free Survival (PFS) at 12 months in patients treated with Ibrutinib plus Rituximab combination in unfit patients with CLL.
Time Frame
At 12 months from treatment start
Secondary Outcome Measure Information:
Title
Number of patients in complete response (CR) or partial response (OR)
Description
Rate of Overall Response Rate (ORR) measured in terms of number of patients in CR/PR at the end of induction therapy.
Time Frame
At the end of induction therapy, that is, 7 months from treatment start
Title
Number of patients in CR
Description
Rate of Complete Responses (CR) measured in terms of number of patients in CR at the end of induction therapy.
Time Frame
At the end of induction therapy, that is, at 7 months from treatment start
Title
Number of negative minimal residual disease CRs
Description
Minimal Residual Disease (MRD) in terms of rate of MRD-negative CRs at the end of induction therapy.
Time Frame
At the end of induction therapy, that is, at 7 months from treatment start
Title
Number of days from treatment discontinuation to new treatment restart.
Description
Time To Next Treatment (TTNT) after treatment discontinuation.
Time Frame
At the end of the study, that is, 90 months from treatment start
Title
Number of patients in event-free survival
Description
Event-Free Survival (EFS) at 36 months.
Time Frame
At 36 months from treatment start
Title
Number of patients in overall survival (OS)
Description
Overall Survival (OS) at 36 months.
Time Frame
At 36 months from treatment start
Title
Number of patients in which there is a hematological improvement
Description
Rate of hematological improvement in patients with baseline anemia, neutropenia and thrombocytopenia defined by hemoglobin >11 g/dL or increase ≥50% over baseline, granulocyte >1500 mm3 or platelet count >100,000/mm3, respectively.
Time Frame
At the end of the study, that is, at 90 months from treatment start
Title
Number of patients with improvement in the immunoglobulin levels
Description
Rate of patients with improvement in the immunoglobulin levels.
Time Frame
At 90 months from treatment start
Title
Number of adverse events and serious adverse events
Time Frame
At 90 months from study start
Title
Number of patients requiring hospitalization
Description
Rate of patients requiring hospitalization, emergency department visits, blood product transfusions and use of hematopoietic growth factors.
Time Frame
At 90 months from study entry
Title
Number of patients in which clinical and biological features can be linked
Description
Rate of ORR, CR, PFS, EFS, TTNT and OS according to clinical and biologic variables: age, size of nodes, CIRS score, stage, ß2-microglobulin, lymphocyte count, stage, CD38, CD49d, ZAP-70, IGVH mutation status, FISH profile (11q del; 17p del; trisomy 12; 13q del; no aberrations) and mutations of TP53, NOTCH1, SF3B1 and BIRC3.
Time Frame
At 90 months from study entry
Title
Number of leukemic subpopulations
Description
Proportion of leukemic and of normal lymphocyte subpopulations, including evaluation of cytokine receptors/adhesion molecules on peripheral blood lymphocytes at week +2 from the start of treatment.
Time Frame
At 90 months from start
Title
Number of patients with RS identified by FDG-PET/CT
Description
Rate of cases of patients with RS or SM identified by FDG-PET/CT
Time Frame
At 90 months from study start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older. Diagnosis of CLL meeting IWCLL criteria. The diagnosis of CLL requires a history of lymphocytosis with a B-lymphocyte count ≥5,000/μL. Prolymphocytes may comprise no more than 55% of blood lymphocytes. Active disease meeting at least 1 of the following IWCLL 2008 criteria for requiring treatment: Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia or thrombocytopenia. Massive (ie, at least 6 cm below the left costal margin), progressive, or symptomatic splenomegaly. Massive nodes (ie, 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 (LDT) of less than 6 months (which may be extrapolated). Lymphocyte doubling time can be obtained by linear regression extrapolation of ALCs obtained at intervals of 2 weeks over an observation period of 2 to 3 months. For patients with initial blood lymphocyte counts of less than 30 x 109/L (30,000/μL), LDT should not be used as a single parameter to define indication for treatment. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL (eg, infections) should be excluded. Constitutional symptoms, defined as 1 or more of the following disease-related symptoms or signs: Unintentional weight loss >10% within the previous 6 months prior to screening Significant fatigue (inability to work or perform usual activities) Fevers higher than 38.0°C for 2 or more weeks without evidence of infection; or Night sweats for more than 1 month without evidence of infection Measurable nodal disease by computed tomography (CT). Measurable nodal disease is defined as at least one lymph node >1.5 cm in longest diameter in a site that has not been previously irradiated. An irradiated lesion may be assessed for measurable disease only if there has been documented progression in that lesion since radiotherapy has ended. No prior treatment. Total CIRS >6 and/or creatinine clearance <70 ml/min [Cockcroft-Gault]). Hematology values within the following limits: Absolute neutrophil count (ANC) ≥1 x 109/L (ie, ≥1000/μL) independent of growth factor support. Platelets ≥50,000/mm3 if bone marrow involvement independent of transfusion support Biochemical values within the following limits: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN) Total bilirubin ≤1.5 x ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin Serum creatinine ≤2 x ULN or estimated Glomerular Filtration Rate (Cockroft Gault) ≥40 mL/min Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree not to donate sperm during and after the study. For females, these restrictions apply for 1 month after the last dose of study drug. For males, these restrictions apply for 3 months after the last dose of study drug. Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [β-hCG]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study. A signed (or signed by their legally-acceptable representatives) informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study. Exclusion Criteria: Any significant concurrent, uncontrolled medical condition or organ system dysfunction and/or laboratory abnormality or psychiatric disease which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk or prevent the subject from signing the informed consent form. Pregnant or lactating females Known presence of alcohol and/or drug abuse. Any potential subject who meets any of the following criteria will be excluded from participating in the study. Major surgery within 4weeks of randomization. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia. Known central nervous system lymphoma. History of stroke or intracranial hemorrhage within 6 months prior to randomization, or of a significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae. Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) in any moment of the study. Requires treatment with strong CYP3A inhibitors. Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Vaccinated with live, attenuated vaccines within 4 weeks of randomization. Known history of human immunodeficiency virus (HIV) positive serology for HIV; active Hepatitis B Virus infection or positive serology for Hepatitis B (HBV) defined as a positive test for HBsAg and HBV-DNA; active Hepatitis C or HCV-RNA positive; any uncontrolled active systemic infection requiring intravenous (IV) antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection; history of tuberculosis within the last five years or recent exposure to tuberculosis equal to or less than 6 months. Richter's syndrome (RS), concomitant or past malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Foà
Organizational Affiliation
Policlinico Umberto I di Roma
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Francesca Mauro
Organizational Affiliation
Policlinico Umberto I di Roma
Official's Role
Study Director
Facility Information:
Facility Name
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
City
Alessandria
Country
Italy
Facility Name
U.O.C. Ematologia e Terapia Cellulare - Ospedale "C. e G. Mazzoni" di Ascoli Piceno
City
Ascoli Piceno
Country
Italy
Facility Name
S.O.C. di Medicina Interna B - Ospedale - Cardinal Massaia di Asti
City
Asti
Country
Italy
Facility Name
UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
City
Bari
Country
Italy
Facility Name
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
City
Bologna
Country
Italy
Facility Name
ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
City
Cagliari
Country
Italy
Facility Name
U.O.C. di Onco-Ematologia - Centro di Ricerca e Formazione ad Alta tecnologia nelle Scienze Biomediche
City
Campobasso
Country
Italy
Facility Name
Unità di Onco-Ematologia - Azienda Ospedaliera - Garibaldi
City
Catania
Country
Italy
Facility Name
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
City
Catanzaro
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
City
Cona
Country
Italy
Facility Name
U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza
City
Cosenza
Country
Italy
Facility Name
Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria
City
Foggia
Country
Italy
Facility Name
IRCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente
City
Genova
Country
Italy
Facility Name
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
City
Lecce
Country
Italy
Facility Name
Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST
City
Meldola
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
City
Messina
Country
Italy
Facility Name
Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
City
Messina
Country
Italy
Facility Name
Ospedale Niguarda " Ca Granda" - SC Ematologia Blocco SUD, Ponti Est, Scala E, 4° piano
City
Milano
Country
Italy
Facility Name
UO Ematologia - AOU Policlinico di Modena
City
Modena
Country
Italy
Facility Name
.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro Gianluca Gaidano S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro Novara Davide Rossi S
City
Novara
Country
Italy
Facility Name
Università degli Studi di Padova - Ematologia ed Immunologia Clinica
City
Padova
Country
Italy
Facility Name
U.O. di Oncoematologia di Nocera Inferiore-plesso ospedaliero "A. Tortora" di Pagani del DEA Nocera-Pagani
City
Pagani
Country
Italy
Facility Name
Cattedra di Ematologia CTMO Università degli Studi di Parma
City
Parma
Country
Italy
Facility Name
S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo
City
Pavia
Country
Italy
Facility Name
Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della Misericordia
City
Perugia
Country
Italy
Facility Name
U.O. Ematologia Clinica - Azienda USL di Pescara
City
Pescara
Country
Italy
Facility Name
Dipartimento Oncologico - Ospedale S.Maria delle Croci
City
Ravenna
Country
Italy
Facility Name
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
City
Reggio Calabria
Country
Italy
Facility Name
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
City
Reggio Emilia
Country
Italy
Facility Name
Ospedale "Infermi"
City
Rimini
Country
Italy
Facility Name
Dipartimento di Biotecnologie Cellulari ed Ematologia - Università degli Studi "Sapienza" di Roma
City
Roma
Country
Italy
Facility Name
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
City
Roma
Country
Italy
Facility Name
U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
City
Siena
Country
Italy
Facility Name
A.O. Santa Maria - Terni S.C Oncoematologia
City
Terni
Country
Italy
Facility Name
Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
City
Torino
Country
Italy
Facility Name
Divisione di Ematologia dell' Università degli Studi di Torino - "Città della Salute e della Scienza di Torino"
City
Torino
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Phase 2 Study to Assess Activity & Safety of Front-line Ibrutinib + Rituximab in Unfit Chronic Lymphocytic Leukemia

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