Trial Title:
Study Evaluating the Efficacy and Tolerance of a Zanubrutinib and BGB-11417 Combination in Patients Previously Treated for Waldenström Macroglobulinemia
NCT ID:
NCT06547866
Condition:
Waldenstrom Macroglobulinemia
Conditions: Official terms:
Waldenstrom Macroglobulinemia
Zanubrutinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
zanubrutinib + BGB-11417
Description:
The investigational medicinal products (IMP) are Zanubrutinib (BGB- 3111) and
BGB-11417.Treatment will be administered for a total of twenty 28 day cycles:
Cycle 1 with zanubrutinib only
Cycle 2 with zanubrutinib plus BGB-11417 ramp-up cycle 2, day 1 : 10mg cycle 2, day 2 :
20 mg cycle 2, day 3 : 40mg cycle 2, day 4-7 : 80md daily cycle 2, day 8 and beyond : 160
mg daily
Cycles 3-20 with zanubrutinib plus BGB-11417 full dose
Arm group label:
Zanubrutinb + BGB-11417
Summary:
This is a French multicenter open label non-randomized Phase II trial evaluating the
efficacy and tolerance of a combination of oral zanubrutinib and BGB-11417 in subjects
aged 18 years and older with previously treated Waldenström macroglobulinemia (WM) who
require therapy according to the consensus panel criteria from the Second International
Workshop on Waldenström's macroglobulinemia.
population : Patients with previously treated Waldenstrom macroglobulinemia
The investigational medicinal products (IMP) are Zanubrutinib (BGB- 3111) and
BGB-11417.Treatment will be administered for a total of twenty 28 day cycles:
- Cycle 1 with zanubrutinib only
- Cycle 2 with zanubrutinib plus BGB-11417 ramp-up
- cycle 2, day 1 : 10mg
- cycle 2, day 2 : 20 mg
- cycle 2, day 3 : 40mg
- cycle 2, day 4-7 : 80md daily
- cycle 2, day 8 and beyond : 160 mg daily
- Cycles 3-20 with zanubrutinib plus BGB-11417 full dose
Detailed description:
study design : Open label, multicenter phase 2 trial
population : Patients with previously treated Waldenstrom macroglobulinemia
Primary objective :
To evaluate the efficacy of a combination of zanubrutinib and BGB-11417 given for a
limited duration of time in Refractory/Relapsing (R/R) WM by the proportion of subjects
achieving either a Complete Response (CR) or Very Good Partial Responses (VGPR).duration
of time in Refractory/relapsing (R/R) Waldenstrom macroglobulinemia (WM)
Secondary objectives:
- To further evaluate the efficacy of a combination of zanubrutinib and BGB-11417
given for a limited duration of time in R/R WM
- To determine the incidence and severity of serum M-protein (monoclonal IgM) rebound
after planned cessation of the combination of zanubrutinib and BGB-11417-101 in R/R
WM
- To evaluate the safety and tolerability of a combination of zanubrutinib and
BGB-11417 given for a limited duration of time in R/R WM
Sample size : 102 patients Length of study: Inclusion period: 24 months Treatment
duration: 18 months (twenty 28-days cycles) Follow-up period: 3 years
Study treatment :
The investigational medicinal products (IMP) are Zanubrutinib (BGB- 3111) and
BGB-11417.Treatment will be administered for a total of twenty 28 day cycles:
- Cycle 1 with zanubrutinib only
- Cycle 2 with zanubrutinib plus BGB-11417 ramp-up
- Cycle 2 with zanubrutinib plus BGB-11417 ramp-up
*cycle 2, day 1 : 10mg
- cycle 2, day 2 : 20 mg
- cycle 2, day 3 : 40mg
- cycle 2, day 4-7 : 80md daily
- cycle 2, day 8 and beyond : 160 mg daily
- Cycles 3-20 with zanubrutinib plus BGB-11417 full dose
All patient will receive both drugs.
Study procedures:
Screening period:
Assessments may be done up to 28 days before the treatment start and will include:
Clinical assessments
- Medical history, WM history including prior treatment lines, previous IPSS WM score,
histology, known cytogenetics and molecular features including MYD88, CXCR4 and TP53
mutational status
- Concomitant therapies
- Complete physical examination, including weight, height, vital signs, ECOG
performance status, B symptoms, detailed evaluation of lymph nodes, liver and spleen
and infection monitoring (including COVID-19 nasal test)
- IPSS WM score
Biological assessments
- Standard hematology tests including CBC (hemoglobin, WBC count, absolute
differential count, platelet count)
- Blood coagulation tests including: prothrombin time, activated cephalin time,
fibrinogen, von Willebrand factor (vWF; including vWF antigen [vWF:Ag] and
vWF:Activity [WF:Act]; evaluation according to ABO blood group) and FVIII* *If
acquired Willebrand syndrome according to hemorrhagic risk assessment, further
analysis is encouraged.
- Blood chemistry tests including sodium, potassium, chloride, bicarbonate, fasting
glucose, phosphate, blood urea nitrogen (BUN), creatinine, calcium, phosphate,
magnesium, total, direct and indirect bilirubin, total protein, albumin, alanine
aminotransferase (ALAT), aspartate aminotransferase (ASAT), lactate dehydrogenase
(LDH), alkaline phosphatase (PAL), uric acid, C-reactive protein (CRP),
beta2microglobulin and pregnancy test
- Troponin; NT-proBNP will be performed on blood
- Serum "M-protein" (monoclonal IgM) quantification based on protein electrophoresis
or alternate methods (according to appendix 3), immunofixation, nephelometry, free
light chains kappa and lambda, cryoglobulinemia
- IgG, IgA and IgM levels
- Serologies for HBV, HCV and HIV
Cardiovascular assessments:
- Cardiovascular evaluation by investigator:
o 12-lead ECG and QTc calculation
o blood pressure after 5 minutes rest, average of 3 measurements separated by ≥ 1
minute.
- Cardiovascular evaluation by cardiologist*:
- 12-lead ECG with QTc calculation
- echocardiography
- 24h Holter ECG monitoring
- 24h Ambulatory blood pressure monitoring (ABPM)
Imaging assessments:
-Whole-Body CT scan (neck, thorax, abdomen, pelvis) with tumor measurements
Specific assessments:
- BM biopsy* (local laboratory).
*This can be omitted if already done within the past 3 months.
- BM aspirate for oLocal laboratory for Cytogenetic analysis and FISH for 17p
oFILOthèque central laboratory, storage for future analysis: unsorted and CD19+
sorted cells for mutational profile.
- Blood MRD assessment on plasmatic cell-free tumor DNA (FILOthèque central
laboratory).
Treatment period
Clinical assessment:
- Concomitant therapies and adverse events, severe adverse events and adverse events
of special interest (AE, SAE and AESI)
- Complete physical examination, including evaluation of lymph nodes, liver and spleen
Cardiovascular assessments:
-Cardiovascular evaluation by investigator after 1, 3, 6, 9, 12, 15 and 18 cycles:
o12-lead ECG and QTc calculation* oblood pressure after a 5 minute rest, average of 3
measurements separated by ≥ 1 minute.
- The 12-lead ECG by investigator is not mandatory if already done or planned during
the cardiology consultation within one month (at cycle 3, 6, 12, and 18)
-Cardiovascular evaluation by cardiologist after 3, 6, 12, and 18 cycles:
ocardiology consultation o24h Holter ECG monitoring* o24h ABPM**
oEchocardiography***
- 24h Holter ECG will be repeated only at cycles 3, 6 and 18 (only risk patient)
- 24h ABMP will be repeated only at cycles 3, 12 and 18
- Echocardiography will be repeated at cycle 18.
Biological assessments (at day 1 +/- 7 days of each cycle):
- Standard hematology tests including CBC (hemoglobin, WBC count, absolute
differential count, platelet count)
- Blood chemistry: including sodium, potassium, chloride, bicarbonate, fasting
glucose, phosphate, BUN, creatinine, calcium, phosphate, magnesium, total, direct
and indirect bilirubin, total protein, albumin, ALAT, ASAT, LDH, PAL, uric acid, CRP
and pregnancy test.
During ramp up period: serum creatinine, sodium, potassium, chloride, bicarbonate,
calcemia, phosphoremia, LDH is mandatory before initiation of any ramp up dose of
BGB-11417, and 8 and 24 hours after drug intake.
- Troponin and NT-proBNP at cycles 1, 3, 6, 9, 12, 15 and 18
- Serum "M-protein" (monoclonal IgM) quantification based on protein electrophoresis
or alternate methods (according to appendix 3) with additional immunofixation (to
confirm CR)
- IgG, IgA and IgM levels
Imaging assessments:
-Whole-body CT scan (neck, thorax, abdomen, pelvis) every 24 weeks (6 cycles) i.e. after
cycles 3, 6, 12 and 18 in all subjects who had measurable nodal/extranodal disease at
screening.
Specific assessments:
-FILOthèque central laboratory: Blood on specific tube for MRD assessment on plasmatic
cell-free tumor DNA (at cycles 3, 6, 12 and 18), storage.
Response evaluation:
Throughout the treatment period, especially before "end of treatment (EOT) + 3 months
(EVAL 2 ) evaluation":
- if a CR is suspected (negative IF), an unscheduled CT scan should be done followed
by biological evaluations including BM biopsy (local laboratory) to confirm CR
- If a VGPR is suspected (≥90% reduction in serum M-protein (monoclonal IgM) level
from baseline (but still detectable) and decreased lymphadenopathy/ splenomegaly (if
present at baseline), an unscheduled CT scan should be done to confirm VGPR.
Evaluation 1 (EVAL 1): 1 month after the end of treatment This evaluation takes place 1
month after EOT either after completion of cycle 20 or after the last cycle in case of
early discontinuation. This evaluation may detect M-protein rebound with or without other
features of early progression.
Clinical assessments:
- Concomitant therapies
- AE, SAE and AESI
- Complete physical examination including evaluation of lymph nodes, liver and spleen
Cardiovascular assessments:
-Cardiovascular evaluation by investigator: o12-lead ECG and QTc calculation oBlood
pressure after a 5 minute rest, average of 3 measurements separated by ≥ 1 minute
Biological assessments:
- Standard hematology tests including CBC (hemoglobin, WBC count, absolute
differential count, platelet count)
- Blood chemistry: sodium, potassium, chloride, bicarbonate, fasting glucose,
phosphate, BUN, creatinine, calcium, phosphate, magnesium, total, direct and
indirect bilirubin, total protein, albumin, ALAT, ASAT, LDH, PAL, uric acid, CRP,
and pregnancy test.
- Serum "M-protein" (monoclonal IgM) quantification based on protein electrophoresis
or alternate methods (according to appendix 3) with additional immunofixation (to
confirm a CR)
- IgG, IgA and IgM levels
Evaluation 2 (=EVAL 2): 3 months after the end of treatment This evaluation takes place 3
months after EOT either after completion of cycle 20 or after the last cycle in case of
early discontinuation. This evaluation may detect M-protein rebound with or without other
features of early progression.
Clinical assessments:
- Concomitant therapies
- AE, SAE and AESI
- Complete physical examination, including evaluation of lymph nodes, liver and spleen
Cardiovascular assessments:
-Cardiovascular evaluation by investigator: o12-lead ECG and QTc calculation oBlood
pressure after 5 minutes rest, average of 3 measurements separated by ≥ 1 minute
-Cardiovascular evaluation by a cardiologist: oCardiology consultation o24h Ambulatory
blood pressure monitoring (ABPM) oEchocardiography
Biological assessments:
- Standard hematology tests including CBC (hemoglobin, WBC count, absolute
differential count, platelet count)
- Blood chemistry: sodium, potassium, chloride, bicarbonate, fasting glucose,
phosphate, BUN, creatinine, calcium, phosphate, magnesium, total, direct and
indirect bilirubin, total protein, albumin, ALAT, ASAT, LDH, PAL, uric acid, CRP
- NT-proBNP
- Serum "M-protein" (monoclonal IgM) quantification based on protein electrophoresis
or alternate methods (according to appendix 3) with additional immunofixation (to
confirm a CR)
- IgG, IgA and IgM levels
Imaging and BM assessments:
- Whole body CT scan
- BM biopsy (local laboratory) if not performed during the treatment period for CR or
progression.
- BM aspirate (FILOthèque central laboratory) for storage and analysis for molecular
studies without CD19 sorting.
- Blood collected on specific tube (FILOthèque central laboratory) for assessment of
plasmatic cell-free tumor DNA
Evaluation in case of suspected CR At any time throughout the study, especially before
"EOT evaluation" when a CR is suspected based on a negative immunofixation, an additional
evaluation should be realized in order to confirm the CR.
This additional evaluation includes primarily:
- Repeated screening for cryoglobulinemia, in patients known to have significant
cryoglobulinemia at screening.
- CT scan
Then, if both immunofixation and CT scan are consistent with CR, a biological assessment
should be scheduled with:
-BM biopsy (local laboratory)
Evaluation in case of suspected VGPR At any time throughout the study, especially before
"EOT evaluation", when a VGPR is suspected based on ≥90% reduction in M-protein
(monoclonal IgM) level from baseline (but still detectable) and decreased
lymphadenopathy/splenomegaly (if present at baseline), an additional evaluation should be
realized in order to confirm the VGPR.
This additional evaluation includes:
- Repeated screening for cryoglobulinemia, in patients known to have significant
cryoglobulinemia at screening.
- CT scan: to confirm the reduction of deep-seated lymphadenopathy and splenomegaly
(if present at baseline)
Evaluation in case of progression during treatment and follow-up period
- BM biopsy optional (local laboratory)
- BM aspirate, indicated according to study only in case of progression for :
- local laboratory: cytogenetics and FISH for 17p
- FILOthèque central laboratory: storage of unsorted and CD19+ sorted cells for
molecular analyzes.
- Blood collected on specific tube for assessment of plasmatic cell-free tumor DNA
(FILOthèque central laboratory).
Post-treatment follow-up period after EVAL 2 Two follow-up evaluations scheduled at 1
month (EVAL 1) and at 3 months (EVAL 2) have been already detailed above. Thereafter, all
patients enrolled in the study will be followed until progression or death every 3 months
the first year (FU6, FU9 and FU12), then every 6 months for a total follow up period of
three years (FU18, FU24, FU30 and FU36).
Clinical assessments:
- Concomitant therapies
- AE, SAE and AESI
- Complete physical examination, evaluation of lymph nodes, liver and spleen.
Cardiovascular assessments:
- Cardiovascular evaluation by investigator o12-lead ECG and QTc calculation oblood
pressure after 5 minutes rest, average of 3 measurements separated by ≥ 1 minute
- Cardiovascular evaluation by a cardiologist (only at FU36) ocardiology consultation
o24h ABPM oEchocardiography
Biological assessments:
- Standard hematology tests including CBC (hemoglobin, WBC count, absolute
differential count, platelet count).
- Blood chemistry: sodium, potassium, chloride, bicarbonate, fasting glucose,
phosphate, BUN, creatinine, calcium, phosphate, magnesium, total, direct and
indirect bilirubin, total protein, albumin, ALAT, ASAT, LDH, PAL, uric acid, CRP
- NT-proBNP (only FU36)
- Serum "M-protein" (monoclonal IgM) quantification based on protein electrophoresis
or alternate methods (according to appendix 3) with additional immunofixation (to
confirm a CR)
- IgG, IgA and IgM levels
Imaging and BM assessments:
- Whole body CT scan if clinically indicated, especially in case of progression.
- BM biopsy (local laboratory)
- BM aspirate, indicated according to study, only in case of progression
Premature end of treatment (PEOT) A visit will be performed 4 weeks (EVAL 1) and 3 months
(EVAL 2) after the last treatment day for patients who discontinue treatment prematurely
and for patients withdrawing their consent (if possible),
In case of PEOT for disease progression, patients will be evaluated
End of study (EOS) The end of study becomes effective after the end of the last study
visit of the last patient enrolled once the FU36 visit has been achieved. The end of
study visit corresponds to the last follow-up visit (FU36). For patients withdrawing
consent during the follow up period, no end of study visit is required.
Observational study For all patients if they consent, the survival data will be collected
every year for an observational study, in the e-CRF (Survival date and/or event date)
until death, for OS analysis.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Be ≥ 18-year-old.
2. Have received at least 1 prior line of treatment (excluding treatment with any BTKi
or Bcl-2 antagonist, see non-inclusion criteria).
3. Provide written informed consent.
4. Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3.
5. Have adequate renal function defined as creatinine clearance ≥ 50 mL/min as
determined by the Cockroft-Gault equation.
6. Have adequate hepatic function defined as:
- total serum bilirubin ≤ 1.5 × ULN, unless bilirubin rise is due to Gilbert's
syndrome or non-hepatic cause.
- alanine aminotransferase (ALAT) < 2 × ULN
- aspartate aminotransferase (ASAT) < 2 × ULN,
7. Have adequate BM function defined as:
- absolute neutrophil count ≥ 1x109/L
- platelet count ≥ 75 x109/L
8. For women of childbearing potential, a negative pregnancy test must be documented
prior to enrollment.
- A woman is considered of childbearing potential, ie, fertile, following
menarche and until becoming postmenopausal unless permanently sterile.
Permanent sterilization methods include hysterectomy, bilateral salpingectomy,
and bilateral oophorectomy.
- A post-menopausal state is defined as no menses for 12 months without an
alternative medical cause.
9. Agree to use a highly effective form of contraception with sexual partners
throughout study participation (for female and male patients who are fertile).
Patients using hormonal contraceptives (eg, birth control pills or devices) must use
a barrier method of contraception (eg, condoms) as well.
10. Ability to comply with study procedures, in the Investigator's opinion.
11. Patient covered by any social security system
Exclusion Criteria:
1. Have previously been treated with a BTK inhibitor.
2. Have been previously treated with a bcl-2 antagonist.
3. Have active central nervous system (CNS) disease as evidenced by cytology or
pathology. In the absence of clinical signs of CNS disease, a lumbar puncture is not
mandatory.
4. Have significant or active cardiovascular disease:
- stage III to IV congestive heart failure (CHF) as determined by the New York
Heart Association (NYHA) classification system for heart failure and/or with
left ventricular ejection fraction < 50%
- myocardial infarction within 6 months before study treatment.
- unstable angina within 6 months before study treatment.
- uncontrolled atrial arrhythmia.
- history of clinically significant ventricular arrhythmias (e.g sustained
ventricular tachycardia, ventricular fibrillation, torsades de pointe).
- uncontrolled hypertension.
- history of stroke or intracranial hemorrhage within 180 days before the first
dose of study drugs
- QTcF interval > 450 ms on screening electrocardiogram (ECG) evaluation.
5. Have a history of stroke or intracranial hemorrhage within 6 months before first
dose of study drug, have a history of a severe bleeding disorder such as hemophilia
A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding
requiring blood transfusion or other medical intervention:
- patients with constitutional hemophilia or von Willebrand's disease will be
excluded.
- patients with acquired hemophilia will be excluded.
- Requires ongoing treatment with warfarin or warfarin derivatives.
- patients with acquired von Willebrand's disease related to WM can be included.
i) if bleeding manifestations are considered as non-clinically significant
(i.e.grade 2 or below) ii) or if bleeding manifestations have been corrected by
plasma exchange
6. Have received live vaccine within 4 weeks of inclusion.
7. Receive other concomitant investigational therapy.
8. Have a history of renal, neurologic, psychiatric, endocrinologic, metabolic,
immunologic, or hepatic condition that, in the opinion of the Investigator, would
adversely affect a subject's participation in the study.
9. Have currently active, clinically significant Child-Pugh Class B or C hepatic
impairment.
10. Present an inability or difficulty swallowing capsules/tablets, malabsorption
syndrome, or any disease or medical condition significantly affecting
gastrointestinal function.
11. Have a known allergy to either xanthine oxidase inhibitors or rasburicase or
zanubrutinib (patients at risk for G6PD deficiency may be screened before
enrolment).
12. Are pregnant or lactating. Women of childbearing potential must agree to use highly
effective contraception from the time of signing informed consent until
end-of-treatment visit,
≥90 days after last dose of BGB-11417-101 and Zanubrutinib. Male patients must be
abstinent, vasectomized, or agree to the use of barrier contraception in combination
with other methods.
13. Have a history of other active malignancies requiring treatment within 3 years of
study entry, with exception of (1) localized basal cell or squamous cell carcinoma
of the skin, (2), adequately treated in situ endometrial carcinoma, (3) incidental
histology finding of prostate carcinoma, (4) previous malignancy confined and
treated locally (surgery or other modality) with curative intent.
14. Be known to be positive for HIV.
15. Present evidence of other clinically significant uncontrolled condition(s)
including, but not limited to:
- uncontrolled and/or active systemic infection (viral, bacterial or fungal)
including COVID-19
- chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note:
subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B
surface [HBs] antigen negative-, anti-HBs antibody positive and anti-hepatitis
B core [c] antibody negative) or positive anti-HBc antibody from intravenous
immunoglobulins (IVIG) may participate. Patients with serologic evidence of
prior resolved infection can be included according to recommendations .
16. Suffer from any condition or illness that, in the opinion of the Investigator or
medical monitor, would compromise patient safety or interfere with the evaluation of
the safety of the study drugs.
17. Have received or consumed any of the following within 3 days prior to the first dose
of study drugs:
- grapefruit or grapefruit products.
- Seville oranges (including marmalade containing Seville oranges).
- star fruit.
18. Have received a treatment with any of the following prior to the first dose of study
drugs:
- ≤7 days steroid therapy with anti-neoplastic intent.
- ≤ 7 days or 5 half-lives (whichever is longer) of any moderate or strong CYP3A4
inhibitor and ≤ 14 days or 5 half-lives, (whichever is longer) of moderate or
strong CYP3A4 inducer before the first dose of study drugs.
- allogeneic or autologous stem cell transplantation or CAR-T cell therapy less
than 3 months before the first dose of study drugs.
19. Severe or debilitating pulmonary disease.
20. Major surgery within 4 weeks of the first dose of study drug.
21. Active and/or ongoing autoimmune anemia and/or autoimmune thrombocytopenia (eg,
idiopathic thrombocytopenia purpura).
22. Ongoing alcohol or drug addiction or any psychiatric condition(s) which would
compromise ability to comply with study procedures.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
AMIENS - CH Amiens Picardie Site Sud
Address:
City:
Amiens
Zip:
80054
Country:
France
Facility:
Name:
Angers Chu
Address:
City:
Angers
Zip:
49933
Country:
France
Facility:
Name:
ANNECY - CH Annecy Genevois
Address:
City:
Annecy
Zip:
74374
Country:
France
Facility:
Name:
ARGENTEUIL - Centre hospitalier Victor Dupouy
Address:
City:
Argenteuil
Country:
France
Facility:
Name:
BAYONNE - CH de la Côte Basque - Hématologie
Address:
City:
Bayonne
Zip:
64109
Country:
France
Facility:
Name:
BESANCON - Hôpital Jean Minjoz
Address:
City:
Besançon
Zip:
25000
Country:
France
Facility:
Name:
Bordeaux-Institut Bergonié
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Facility:
Name:
CAEN - CHU Caen - IHBN
Address:
City:
Caen
Zip:
14033
Country:
France
Facility:
Name:
Clermont-Ferrand - Chu Estaing
Address:
City:
Clermont-Ferrand
Zip:
63000
Country:
France
Facility:
Name:
CRETEIL - CHU Henri Mondor
Address:
City:
Créteil
Zip:
94000
Country:
France
Facility:
Name:
DIJON - Hôpital François Mitterrand
Address:
City:
Dijon
Zip:
21000
Country:
France
Facility:
Name:
Grenoble - CHUGA - Hématologie Clinique
Address:
City:
Grenoble
Zip:
38043
Country:
France
Facility:
Name:
La Roche Sur Yon - Chd Vendee
Address:
City:
La Roche-sur-Yon
Zip:
85925
Country:
France
Facility:
Name:
Le Mans CH
Address:
City:
Le Mans
Country:
France
Facility:
Name:
LILLE GHICL - Hôpital Saint Vincent de Paul
Address:
City:
Lille
Zip:
59000
Country:
France
Facility:
Name:
LILLE CHU - Hôpital Claude Huriez
Address:
City:
Lille
Zip:
59037
Country:
France
Facility:
Name:
LYON-Centre Léon Bérard
Address:
City:
Lyon
Zip:
69008
Country:
France
Facility:
Name:
MARSEILLE - Institut Paoli-Calmettes
Address:
City:
Marseille
Zip:
13000
Country:
France
Facility:
Name:
MONTPELLIER - Hôpital Saint-Eloi - Hématologie Clinique
Address:
City:
Montpellier
Zip:
34295
Country:
France
Facility:
Name:
Mulhouse - Ghrmsa
Address:
City:
Mulhouse
Zip:
68100
Country:
France
Facility:
Name:
NANTES - Hôpital Hôtel Dieu - Hématologie Clinique
Address:
City:
Nantes
Zip:
44093
Country:
France
Facility:
Name:
ORLEANS - CHR - Hématologie
Address:
City:
Orléans
Zip:
44100
Country:
France
Facility:
Name:
APHP - Hôpital Pitié Salpêtrière - Hématologie
Address:
City:
Paris
Zip:
75651
Country:
France
Facility:
Name:
PERPIGNAN - CH St Jean - Hématologie Clinique
Address:
City:
Perpignan
Zip:
66000
Country:
France
Facility:
Name:
Bordeaux Pessac
Address:
City:
Pessac
Zip:
33604
Country:
France
Facility:
Name:
LYON HCL - CH Lyon Sud
Address:
City:
Pierre-Bénite
Zip:
69036
Country:
France
Facility:
Name:
POITIERS - Hématologie et Thérapie Cellulaire
Address:
City:
Poitiers
Zip:
86021
Country:
France
Facility:
Name:
Reims Chu
Address:
City:
Reims
Zip:
51092
Country:
France
Facility:
Name:
RENNES - CHU Pontchaillou - Hématologie Clinique
Address:
City:
Rennes
Zip:
35033
Country:
France
Facility:
Name:
ROUEN - Centre Henri Becquerel - Service Hématologie Clinique
Address:
City:
Rouen
Zip:
76038
Country:
France
Facility:
Name:
Strasbourg - Icans
Address:
City:
Strasbourg
Zip:
67033
Country:
France
Facility:
Name:
Toulouse - IUCT Oncopole - Service d'Hématologie
Address:
City:
Toulouse
Zip:
31059
Country:
France
Facility:
Name:
TOURS - Hôpital Bretonneau
Address:
City:
Tours
Zip:
37000
Country:
France
Facility:
Name:
NANCY - CHU Brabois
Address:
City:
Vandœuvre-lès-Nancy
Zip:
54500
Country:
France
Facility:
Name:
Vannes - Chba
Address:
City:
Vannes
Country:
France
Facility:
Name:
VERSAILLES - Hôpital André Mignot
Address:
City:
Versailles
Country:
France
Facility:
Name:
Villejuif Igr
Address:
City:
Villejuif
Country:
France
Start date:
October 1, 2024
Completion date:
March 31, 2031
Lead sponsor:
Agency:
French Innovative Leukemia Organisation
Agency class:
Other
Collaborator:
Agency:
BeiGene
Agency class:
Industry
Source:
French Innovative Leukemia Organisation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06547866
