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STop and Restart Acalabrutinib In fRail Patients With Previously Untreated Chronic Lymphocytic Leukemia (STAIR)

Primary Purpose

Untreated Chronic Lymphocytic Leukemia

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Stop ACA
ACA Continuation
Sponsored by
French Innovative Leukemia Organisation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Untreated Chronic Lymphocytic Leukemia

Eligibility Criteria

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

Inclusion Criteria:

  • Age > 70 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status < 2
  • Previously untreated CLL or Small Lymphocytic Lymphoma (SLL)
  • CLL or SLL requiring treatment according to the iwCLL 2018 criteria2
  • Total Cumulative Illness Rating Scale (CIRS) score > 6 or 30 < CrCl < 69 mL/min
  • Both patients with or without TP53 disruption 17p deletion and/or TP53 mutations) can be included
  • Patients can be included whatever their IGHV mutational status
  • Patients with therapy-controlled cardiovascular comorbidities and/or anticoagulation (novel oral anticoagulant alone, aspirin alone, heparin alone) can be included (patients treated by vitamin K antagonist or dual anti-platelet therapy cannot be included)
  • Life expectancy > 6 months
  • Adequate hematology values: absolute neutrophil count ≥ 0.75 x 109/L, platelet count ≥ 50 x 109/L.
  • Adequate liver function as indicated by a total bilirubin <1.5, aspartate transaminase and alanine transaminase ≤3 the institutional upper limits of normal values, unless directly attributable to CLL
  • Signed (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including specify biology analysis, and are willing to participate in the study.

Exclusion Criteria:

  • Known HIV seropositivity
  • Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:

    • Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
    • Known history of human immunodeficiency virus, serologic status reflecting active hepatitis B virus or hepatitis C virus infection, any uncontrolled active systemic infection along with subjects who are on ongoing anti-infective treatment and subjects who have received vaccination with a live attenuated vaccine within 4 weeks before the first dose of study treatment

      1. Subjects who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antibody (anti-HBs) negative will need to have a negative hepatitis B virus Polymerase Chain Reaction (PCR) result before enrollment. Those who are hepatitis B surface antigen (HBsAg) positive or hepatitis B virus PCR positive will be excluded.
      2. Subjects who are hepatitis C virus antibody positive will need to have a negative hepatitis C virus PCR result before enrollment. Those who are hepatitis C virus PCR positive will be excluded
    • Active and uncontrolled autoimmune cytopenia, including autoimmune hemolytic anemia (AIHA) (isolated positive Direct Antiglobulin Testing (DAT) is not an exclusion criteria) and idiopathic thrombocytopenic purpura (ITP).
    • Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura.
  • Patients treated by vitamin K antagonist or dual anti-platelet therapy
  • History of bleeding diathesis (e.g. hemophilia or von Willebrand disease)
  • History of confirmed progressive multifocal leukoencephalopathy (PML).
  • Concurrent severe diseases which exclude the administration of therapy :

    • heart insufficiency New York Heart Association (NYHA) grade III/IV, Left Ventricular Ejection Fraction (LEVF) < 50% and or Recirculation Fraction (RF) < 30%, myocardial infarction within the past 6 months prior to study
    • Significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional (Subjects with controlled, asymptomatic atrial fibrillation are allowed to enroll on study)
    • severe chronic obstructive lung disease with hypoxemia
    • history of stroke or intra-cranial hemorrhage within the last 6 months
    • severe diabetes mellitus
    • uncontrolled hypertension
    • impaired renal function with creatinine clearance < 30 ml/min according the formula of Cockcroft and Gault
    • Patient who requires treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving proton-pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study.
  • Disease significantly affecting gastrointestinal function (malabsorption syndrome, stomach or small bowel resection)
  • Evidence for Richter syndrome
  • Treatment with any of the following within 7 days prior to the first dose of study drug: steroid therapy for anti-neoplastic intent.
  • A significant history of renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, or hepatic disease that, in the opinion of the investigator, would adversely affect the patient's participation in this study or interpretation of study outcomes
  • Major surgery within 30 days prior to the first dose of study treatment.
  • History of prior other malignancy that could affect compliance with the protocol or interpretation of results, with the exception of the following:

    • curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix at any time prior to study.
    • other cancers not specified above that have been curatively treated by surgery and/or radiation therapy from which patient is disease-free for ≥ 5 years without further treatment
  • Adult under law-control
  • Fertile male patients who cannot or do not wish to use an effective method of contraception, during and for 12 months after the final treatment used for the purposes of the study
  • No affiliation to social security

Sites / Locations

  • Chu AngersRecruiting
  • ARGENTEUIL - Centre hospitalier Victor DupouyRecruiting
  • Ch AvignonRecruiting
  • Ch Cote BasqueRecruiting
  • BOBIGNY - Hôpital AvicenneRecruiting
  • Hôpital Privé SévignéRecruiting
  • CHU Estaing - Hématologie Clinique AdulteRecruiting
  • Corbeil-Essonnes -Recruiting
  • CHU Grenoble - HématologieRecruiting
  • Centre Hospitalier du MansRecruiting
  • Hôpital Saint Vincent de PaulRecruiting
  • Centre Léon Bérard - HématologieRecruiting
  • Institut Paoli-Calmettes - Hématologie CliniqueRecruiting
  • Centre Hospitalier Regional Metz Thionville
  • Hôpital Saint-Eloi - Hématologie CliniqueRecruiting
  • Hopital E.MullerRecruiting
  • CHR ORLEANS - HématologieRecruiting
  • Hopital Pitie Salpetriere Service Hematologie Clinique - Pavillon de L'Enfant Et AdolescentRecruiting
  • CENTRE HOSPITALIER SAINTJEAN - Hématologie CliniqueRecruiting
  • Bordeaux PessacRecruiting
  • Centre Hospitalier Lyon SudRecruiting
  • Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire
  • CERGY-PONTOISE - Centre Hospitalier René DubosRecruiting
  • Chu ReimsRecruiting
  • CHU Pontchaillou - Hématologie Clinique BMT-HCRecruiting
  • Centre Henri Becquerel - Service Hématologie CliniqueRecruiting
  • Institut de Cancérologie Lucien Neuwirth
  • IUCT ONCOPOLE - HématologieRecruiting
  • Hôpital Bretonneau - Hématologie et Thérapie CellulaireRecruiting
  • CHU Nancy BraboisRecruiting
  • Vannes - ChbaRecruiting
  • VERSAILLES - Hôpital André MignotRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

watch and monitor

Acalabrutinib

Arm Description

After 18 months of acalabrutinib treatment, patients will stop acalabrutinib treatment for watch and monitor until month 60. If progression disease, patients will be re-treated with ACA at the last received dose after central reviewing of treatment criteria.

After 18 months of acalabrutinib treatment, patients will continue acalabrutinib treatment until month 60. If progression disease or unacceptable toxicity, patients will receive next line therapy at the discretion of their physicians and according to iwCLL 2018 criteria

Outcomes

Primary Outcome Measures

Progression-free survival (PFS) at one year after acalabrutinib interruption
Time from randomization (M19 : discontinuation of acalabrutinib after of 18 months treatment) to progression (needing therapy or not) or death from any cause

Secondary Outcome Measures

Full Information

First Posted
July 6, 2021
Last Updated
May 23, 2023
Sponsor
French Innovative Leukemia Organisation
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1. Study Identification

Unique Protocol Identification Number
NCT04963946
Brief Title
STop and Restart Acalabrutinib In fRail Patients With Previously Untreated Chronic Lymphocytic Leukemia
Acronym
STAIR
Official Title
STop and Restart Acalabrutinib In fRail Patients With Previously Untreated Chronic Lymphocytic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Innovative Leukemia Organisation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The irreversible Bruton's Tyrosine Kinase (BTK) inhibitor acalabrutinib (ACA) has potent clinical activity as a single agent in patients with treatment naive and Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL). However, a growing body of concerns is raising regarding the unlimited administration of targeted therapy as BTKi. First, long-term treatments expose the patients to increased risk of specific adverse events (infections, bleeding events or cardiovascular problems). Second, continuous administration might also increase the risk of clonal evolution and therapeutic resistance resulting from genetic alterations such as BTK or PLCG2 mutations. Discontinuation of therapy after a fixed period is expected to prevent these events. Rapid and deep responses yielded by ACA in elderly patients pave the way of investigating a limited 18-months period schedule. This study aims to investigate the 1-year PFS upon ACA discontinuation and efficacy of restarting ACA upon symptomatic relapse.
Detailed Description
This multicenter, non comparative, randomized phase II trial aims at evaluating the impact of a stopping ACA strategy on PFS of CLL patients >70 years or with coexisting comorbidities. Patients will receive continuous Acalabrutinib (ACA) at 100 mg bid for 18 months. Dose adaptations will be made according to labels. In case of first occurrence of grade ≥3 non-hematological toxicity, febrile grade ≥3 neutropenia or grade ≥4 hematological toxicity treatment must be stopped until recovering grade 1 or baseline state. 1st and second occurrence : restart at 100 mg twice daily 3rd occurrence : restart at 100 mg once daily 4th occurrence : discontinue acalabrutinib At month 19 day 1, patients will be randomized (1:2) in two arms: Arm 1 = Control arm (acalabrutinib) continuing acalabrutinib until disease progression or unacceptable toxicity or Arm 2 = Experimental arm (watch and monitor) without ACA (see trial design). Upon progression in the experimental arm, all patients will be re-treated with ACA at the last received dose after central reviewing of treatment criteria. Upon progression in the control arm, patients will receive next line therapy at the discretion of their physicians and according to iwCLL 2018 criteria. Patients will be monitored every three months until M31 then every 6 months until M60 or progression for both response and toxicity according to CTCAE v.5. Minimal/Measurable Residual Disease (MRD) assessment will be done at month 19 day 1 in the peripheral blood. CT-scan will be performed at baseline, then at month 19 day 1 and every 6 months within the year after randomization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Untreated Chronic Lymphocytic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
multicenter, non comparative, randomized, stop and restart
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
watch and monitor
Arm Type
Experimental
Arm Description
After 18 months of acalabrutinib treatment, patients will stop acalabrutinib treatment for watch and monitor until month 60. If progression disease, patients will be re-treated with ACA at the last received dose after central reviewing of treatment criteria.
Arm Title
Acalabrutinib
Arm Type
Active Comparator
Arm Description
After 18 months of acalabrutinib treatment, patients will continue acalabrutinib treatment until month 60. If progression disease or unacceptable toxicity, patients will receive next line therapy at the discretion of their physicians and according to iwCLL 2018 criteria
Intervention Type
Drug
Intervention Name(s)
Stop ACA
Intervention Description
discontinuation of acalabrutinib after 18 months in treatment-naïve CLL patients
Intervention Type
Drug
Intervention Name(s)
ACA Continuation
Intervention Description
continuation of acalabrutinib at the same dose
Primary Outcome Measure Information:
Title
Progression-free survival (PFS) at one year after acalabrutinib interruption
Description
Time from randomization (M19 : discontinuation of acalabrutinib after of 18 months treatment) to progression (needing therapy or not) or death from any cause
Time Frame
until 12 months after acalabrutinib interruption

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 70 years or older Eastern Cooperative Oncology Group (ECOG) performance status < 2 Previously untreated CLL or Small Lymphocytic Lymphoma (SLL) CLL or SLL requiring treatment according to the iwCLL 2018 criteria2 Total Cumulative Illness Rating Scale (CIRS) score > 6 or 30 < CrCl < 69 mL/min Both patients with or without TP53 disruption 17p deletion and/or TP53 mutations) can be included Patients can be included whatever their IGHV mutational status Patients with therapy-controlled cardiovascular comorbidities and/or anticoagulation (novel oral anticoagulant alone, aspirin alone, heparin alone) can be included (patients treated by vitamin K antagonist or dual anti-platelet therapy cannot be included) Life expectancy > 6 months Adequate hematology values: absolute neutrophil count ≥ 0.75 x 109/L, platelet count ≥ 50 x 109/L. Adequate liver function as indicated by a total bilirubin <1.5, aspartate transaminase and alanine transaminase ≤3 the institutional upper limits of normal values, unless directly attributable to CLL Signed (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including specify biology analysis, and are willing to participate in the study. Exclusion Criteria: Known HIV seropositivity Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: Uncontrolled and/or active systemic infection (viral, bacterial or fungal) Known history of human immunodeficiency virus, serologic status reflecting active hepatitis B virus or hepatitis C virus infection, any uncontrolled active systemic infection along with subjects who are on ongoing anti-infective treatment and subjects who have received vaccination with a live attenuated vaccine within 4 weeks before the first dose of study treatment Subjects who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antibody (anti-HBs) negative will need to have a negative hepatitis B virus Polymerase Chain Reaction (PCR) result before enrollment. Those who are hepatitis B surface antigen (HBsAg) positive or hepatitis B virus PCR positive will be excluded. Subjects who are hepatitis C virus antibody positive will need to have a negative hepatitis C virus PCR result before enrollment. Those who are hepatitis C virus PCR positive will be excluded Active and uncontrolled autoimmune cytopenia, including autoimmune hemolytic anemia (AIHA) (isolated positive Direct Antiglobulin Testing (DAT) is not an exclusion criteria) and idiopathic thrombocytopenic purpura (ITP). Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura. Patients treated by vitamin K antagonist or dual anti-platelet therapy History of bleeding diathesis (e.g. hemophilia or von Willebrand disease) History of confirmed progressive multifocal leukoencephalopathy (PML). Concurrent severe diseases which exclude the administration of therapy : heart insufficiency New York Heart Association (NYHA) grade III/IV, Left Ventricular Ejection Fraction (LEVF) < 50% and or Recirculation Fraction (RF) < 30%, myocardial infarction within the past 6 months prior to study Significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional (Subjects with controlled, asymptomatic atrial fibrillation are allowed to enroll on study) severe chronic obstructive lung disease with hypoxemia history of stroke or intra-cranial hemorrhage within the last 6 months severe diabetes mellitus uncontrolled hypertension impaired renal function with creatinine clearance < 30 ml/min according the formula of Cockcroft and Gault Patient who requires treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving proton-pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. Disease significantly affecting gastrointestinal function (malabsorption syndrome, stomach or small bowel resection) Evidence for Richter syndrome Treatment with any of the following within 7 days prior to the first dose of study drug: steroid therapy for anti-neoplastic intent. A significant history of renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, or hepatic disease that, in the opinion of the investigator, would adversely affect the patient's participation in this study or interpretation of study outcomes Major surgery within 30 days prior to the first dose of study treatment. History of prior other malignancy that could affect compliance with the protocol or interpretation of results, with the exception of the following: curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix at any time prior to study. other cancers not specified above that have been curatively treated by surgery and/or radiation therapy from which patient is disease-free for ≥ 5 years without further treatment Adult under law-control Fertile male patients who cannot or do not wish to use an effective method of contraception, during and for 12 months after the final treatment used for the purposes of the study No affiliation to social security
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Delphine NOLLET
Phone
218370609
Ext
+33
Email
d.nollet@chu-tours.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Valérie ROUILLE, Pr
Phone
467332645
Ext
+33
Email
v-rouille@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loïc Ysebaert, Pr
Organizational Affiliation
French Innovative Leukemia Organisation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Romain GUIEZE, Pr
Organizational Affiliation
French Innovative Leukemia Organisation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aline CLAVERT, MD
Phone
+33 2 41 35 45 24
Email
aline.clavert@chu-angers.fr
Facility Name
ARGENTEUIL - Centre hospitalier Victor Dupouy
City
Argenteuil
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Driss CHAOUI
Facility Name
Ch Avignon
City
Avignon
ZIP/Postal Code
84000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Safia CHEBREK, Dr
Phone
+33 4 32 75 93 00
Email
chebrek.safia@ch-avignon.fr
Facility Name
Ch Cote Basque
City
Bayonne
ZIP/Postal Code
64109
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie GAY, MD
Phone
+33559443832
Email
jgay@ch-cotebasque.fr
Facility Name
BOBIGNY - Hôpital Avicenne
City
Bobigny
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent LEVY, Pr
Facility Name
Hôpital Privé Sévigné
City
Cesson-Sévigné
ZIP/Postal Code
35510
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier CAHU, Dr
Phone
33 (0)2 23 21 05 50
Email
cahu.xavier@yahoo.fr
Facility Name
CHU Estaing - Hématologie Clinique Adulte
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romain GUIEZE, Dr
Phone
+33 4 73 75 00 65
Email
rguieze@chu-clermontferrand.fr
Facility Name
Corbeil-Essonnes -
City
Corbeil-Essonnes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence SIMON, Dr
Facility Name
CHU Grenoble - Hématologie
City
Grenoble
ZIP/Postal Code
388043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lysiane MOLINA, Dr
Phone
04 76 76 57 55
Email
LMolina@chu-grenoble.fr
Facility Name
Centre Hospitalier du Mans
City
Le Mans
ZIP/Postal Code
72000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamel LARIBI, Dr
Phone
02 43 43 43 43
Email
klaribi@ch-lemans.fr
Facility Name
Hôpital Saint Vincent de Paul
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bénédicte HIVERT, Dr
Phone
33 (0)3 20 87 45 32
Email
hivert.benedicte@ghicl.net
Facility Name
Centre Léon Bérard - Hématologie
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Sophie MICHALLET, Dr
Phone
04 78 78 26 41
Email
anne-sophie.michallet@lyon.unicancer.fr
Facility Name
Institut Paoli-Calmettes - Hématologie Clinique
City
Marseille
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thérèse AURRAN, Dr
Phone
04 91 22 38 68
Email
aurrant@ipc.unicancer.fr
Facility Name
Centre Hospitalier Regional Metz Thionville
City
Metz
ZIP/Postal Code
57085
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe CARASSOU, MD
Phone
+333 87 55 33 63
Email
p.carassou@chr-metz-thionville.fr
Facility Name
Hôpital Saint-Eloi - Hématologie Clinique
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emanuelle TCHERNONOG, Dr
Phone
04 67 33 24 17
Email
e-tchernonog@chu-montpellier.fr
Facility Name
Hopital E.Muller
City
Mulhouse
ZIP/Postal Code
68100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernard DRENOU, Dr
Phone
03 89 64 77 85
Email
drenoub@ghrmsa.fr
Facility Name
CHR ORLEANS - Hématologie
City
Orléans
ZIP/Postal Code
44100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marlene OCHMANN, Dr
Email
marlene.ochmann@chr-orleans.fr
Facility Name
Hopital Pitie Salpetriere Service Hematologie Clinique - Pavillon de L'Enfant Et Adolescent
City
Paris
ZIP/Postal Code
75651
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien ROOS WEIL, Dr
Phone
01 42 16 15 96
Email
damien.roosweil@aphp.fr
Facility Name
CENTRE HOSPITALIER SAINTJEAN - Hématologie Clinique
City
Perpignan
ZIP/Postal Code
66000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence SANHES, Dr
Phone
+33(0)4 68 61 89 02
Email
laurence.sanhes@ch-perpignan.fr
Facility Name
Bordeaux Pessac
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Sarah DILHUYDY, MD
Phone
+33557656511
Email
marie-sarah.dilhuydy@chu-bordeaux.fr
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuelle FERRANT, MD
Phone
+33478864521
Email
emmanuel.ferrant2@chu-lyon.fr
Facility Name
Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile TOMOWIAK, Dr
Phone
05 49 44 43 07
Email
cecile.tomowiak@chu-poitiers.fr
Facility Name
CERGY-PONTOISE - Centre Hospitalier René Dubos
City
Pontoise
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugo Gonzalez, Dr
Facility Name
Chu Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne QUINQUENEL, Dr
Phone
33 (0)3 26 78 36 44
Email
aquiquennel@chu-reims.fr
Facility Name
CHU Pontchaillou - Hématologie Clinique BMT-HC
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie DE GUIBERT, Pr
Phone
02 99 28 42 91
Email
sophie.de.guibert@chu-rennes.fr
Facility Name
Centre Henri Becquerel - Service Hématologie Clinique
City
Rouen
ZIP/Postal Code
76038
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane LEPRETRE, Pr
Phone
+33 2 32 08 29 46
Email
stephane.lepretre@chb.unicancer.fr
Facility Name
Institut de Cancérologie Lucien Neuwirth
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42271
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie CHALAYER, Dr
Email
emilie.chalayer@icloire.fr
Facility Name
IUCT ONCOPOLE - Hématologie
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loïc YSEBAERT, Dr
Phone
05 31 15 63 51
Email
ysebaert.loic@iuct-oncopole.fr
Facility Name
Hôpital Bretonneau - Hématologie et Thérapie Cellulaire
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline DARTIGEAS, Dr
Phone
02 47 47 37 12
Email
c.dartigeas@chu-tours.fr
Facility Name
CHU Nancy Brabois
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre FEUGIER, Pr
Phone
33 (0)3 83 15 32 82
Email
p.feugier@chru-nancy.fr
Facility Name
Vannes - Chba
City
Vannes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine BONNET, Dr
Facility Name
VERSAILLES - Hôpital André Mignot
City
Versailles
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatiha MERABET, Dr

12. IPD Sharing Statement

Plan to Share IPD
No

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STop and Restart Acalabrutinib In fRail Patients With Previously Untreated Chronic Lymphocytic Leukemia

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