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Evaluation of CPX-351 Monotherapy in Acute Myeloid Leukemia Secondary to Myeloproliferative Neoplasm (CPX-351 TA-SMP)

Primary Purpose

Acute Myeloid Leukemia, Myeloproliferative Syndrome

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
CPX-351
Sponsored by
French Innovative Leukemia Organisation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of newly secondary AML according to WHO 2016 classification following an antecedent of Myeloproliferative Neoplasm including Essential Thrombocythemia (ET), Polycythemia Vera (PV), primary or secondary Myelofibrosis
  • Performance status 2 Eastern Cooperative Oncology Group (ECOG) grading.
  • Eligible for standard intensive chemotherapy
  • Absence of concomitant severe cardiovascular disease which would make intensive chemotherapy impossible, i.e. arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease, reduced left ventricular function assessed by multigated acquisition (MUGA) scan or echocardiogram. Cardiac ejection fraction ≥ 50% by echocardiography ou MUGA
  • Patient must have adequate organ function as indicated by the following laboratory values:

    • Renal

      • Serum creatinine: < 2 mg/dl OR calculated creatinine clearance*: ≥ 30 mL/min by MDRD formula for patients with creatinine levels > 1.5 X institutional Upper Limit Normal (ULN)
    • Hepatic

      • Serum total bilirubin: ≤ 2.5 X ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels ≥ 2 mg/dL unless Gilbert's Syndrome
      • Aspartate-Amino-Transferase (ASAT) and Alanine-Transaminase (ALAT): ≤ 2.5 times ULN
      • Alkaline Phosphatase: ≤ 5 X ULN, if > 2.5 X ULN, then liver fraction should be ≤ 2.5 X ULN *Creatinine clearance should be calculated per institutional standard
  • Life expectancy should be of 12 weeks at least according to investigator evaluation
  • Female patients of childbearing potential must have a negative serum pregnancy test (β-hCG) within 72 hours prior to receiving the first dose of CPX-351. Female patients who are not post-menopausal, free from menses for > 2 years or surgically sterilized, will have to use adequate barrier methods of contraception to prevent pregnancy or agree to abstain from becoming pregnant throughout the study, starting with Visit 1.
  • Male patients agree to use an adequate method of contraception for the duration of the study. Men should be advised not to father a child while receiving CPX-351 and for 3 months post study.
  • Patients have the ability to understand and willingness to sign an informed consent form indicating the investigational nature of the study.

Exclusion Criteria:

  • MPN/MDS mixed types
  • Prior therapy for AML transformation except for Hydroxyurea
  • Prior treatment with growth factors such as erythropoietin alfa (EPO) or granulocyte colony-stimulating factor (G-CSF), low-dose oral chemotherapy or Hypomethylating agents chemotherapy given in the chronic phase of MPN in the 30 days before inclusion, except for hydroxyurea.
  • Uncontrolled undercurrent illness or circumstances that could limit compliance with the study, including but not limited to the following: symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, pancreatitis, or psychiatric or social conditions that may interfere with patient compliance.
  • Active and uncontrolled infection
  • Current participation or participation in a study with an investigational compound or device within 30 days of initial dosing with study drug
  • Patients with acute promyelocytic leukemia.
  • Known human immunodeficiency virus (HIV) infection or HIV-related malignancy
  • Clinically active hepatitis B or hepatitis C infection.
  • Known allergy or hypersensitivity to any component of CPX-351.
  • Currently active second malignancy, other than non-melanoma skin cancer and in situ carcinoma of the cervix. Patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for >3 years or are considered by their physician to be at less than 30% risk of relapse
  • Clinical evidence of Central Nervous System Leukemia.
  • Pregnancy or breastfeeding during the projected duration of the study.

Sites / Locations

  • AMIENS - CHU Amiens PicardieRecruiting
  • ANGERS - CHU - Maladies du sangRecruiting
  • AVIGNON - Centre HospitalierRecruiting
  • BAYONNE - CH de la Côte Basque - HématologieRecruiting
  • AVICENNE - Centre de Recherche Clinique
  • BREST - Hôpital Morvan
  • CAEN - CHU Caen - IHBN
  • CLAMART - Hôpital d'Instruction des Armées de PercyRecruiting
  • Clermont-Ferrand - Chu EstaingRecruiting
  • CRETEIL - CHU Henri Mondor
  • Grenoble - CHUGA - Hématologie CliniqueRecruiting
  • LILLE CHU - Hôpital Claude HuriezRecruiting
  • LIMOGES - CHU Dupuytren 1
  • LYON-Centre Léon BérardRecruiting
  • MARSEILLE - Institut Paoli-CalmettesRecruiting
  • MONTPELLIER - Hôpital Saint-Eloi - Hématologie CliniqueRecruiting
  • NANTES - Hôpital Hôtel Dieu - Hématologie CliniqueRecruiting
  • NICE - Centre Antoine LacassagneRecruiting
  • NICE - CHU - Hopital Archet 1Recruiting
  • NIMES - CHU CaremeauRecruiting
  • ORLEANS - CHR - HématologieRecruiting
  • Paris St Antoine
  • Paris Saint Louis
  • BORDEAUX - Hôpital Haut-LevêqueRecruiting
  • LYON HCL - CH Lyon SudRecruiting
  • POITIERS - Hôpital La Milétrie - Hématologie Clinique
  • REIMS - Hôpital Robert Debré - Hématologie CliniqueRecruiting
  • RENNES - Hôpital Pontchaillou - Hématologie
  • Strasbourg - IcansRecruiting
  • Toulouse - IUCT Oncopole - Service d'HématologieRecruiting
  • TOURS - Hôpital BretonneauRecruiting
  • NANCY - CHU de Brabois
  • VERSAILLES - Hôpital André Mignot
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CPX351

Arm Description

Induction : patients will receive induction treatment with CPX-351 100 U/m2 on days 1, 3, and 5. Patients who fail to achieve CR/CRi after the induction cycle will be offered a second induction course of CPX-351 100 U/m2 on days 1 and 3, at the investigators' discretion. If CR/CRi is not achieved following the second induction cycle, patients will go off study Consolidation : patients in CR/CRi after induction cycle will receive up to 2 course of CONSOLIDATION therapy with CPX-351 65 U/m2 on days 1 and 3. CPX351 doses could be reduced to 65 U/m2 on day 1 in case of unacceptable toxicity following the previous course.

Outcomes

Primary Outcome Measures

Rate of CR/CRi after first induction therapy
Rate of CR/CRi according to ELN2017 criteria
Rate of CR/CRi after second induction therapy
Rate of CR/CRi according to ELN2017 criteria

Secondary Outcome Measures

Full Information

First Posted
July 19, 2021
Last Updated
October 17, 2022
Sponsor
French Innovative Leukemia Organisation
Collaborators
Acute Leukemia French Association, French Intergroup of Myeloproliferative syndromes
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1. Study Identification

Unique Protocol Identification Number
NCT04992949
Brief Title
Evaluation of CPX-351 Monotherapy in Acute Myeloid Leukemia Secondary to Myeloproliferative Neoplasm
Acronym
CPX-351 TA-SMP
Official Title
A Phase II Study of CPX-351 Monotherapy in Acute Myeloid Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2022 (Actual)
Primary Completion Date
July 21, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Innovative Leukemia Organisation
Collaborators
Acute Leukemia French Association, French Intergroup of Myeloproliferative syndromes

4. Oversight

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

5. Study Description

Brief Summary
The three classic myeloproliferative neoplasms (MPNs) include polycythemia Vera (PV), essential thrombocythemia (ET) and primary myelofibrosis (PMF). The natural history of these MPNs is the possible progression to acute myeloid leukemia (MPN-blast phase) at variable percentage depending the entity. Leukemic transformation of MPN occurs in 8% to 23% of primary myelofibrosis (PMF) patients in the first 10 years after diagnosis and in 4% to 8% of polycythemia vera (PV) and essential thrombocytosis (ET) patients within 18 years after diagnosis. The risk for leukemic transformation is increased by exposure to cytotoxic chemotherapy. The molecular pathogenesis of MPN-blast phase remains an area of active research. The prognosis of blast phase MPNs is very poor : approximately 50% of the patients are deemed eligible for intensive treatment (ie. conventional induction chemotherapy regimen with anthracyclines and cytarabine). The patients who are not fit for such intensive treatment approach due to age or comorbidities, are treated with Hypomethylating agents, low dose palliative chemotherapy, or supportive care. Nevertheless, there is a need for more effective and better tolerated treatment approaches in order to increase the response rate and hence, the transplant rates which should translate into improved survival. CPX-351 is a new formulation of cytarabine and daunorubicin encapsulated at a fixed 5:1 molar-ratio in liposomes that exploits molar ratio-dependent drug-drug synergy to enhance antileukemic efficacy. Based on similarities between post-myelodysplastic syndrome (MDS) and post-MPN secondary AML in terms of disease resistance to chemotherapy, of fragile patient profile, The hypotheses made is that CPX-351 may improve the results of induction chemotherapy without increasing its toxicity and therefore may increase the proportion of patients who could benefit from an allogeneic Stem Cell Transplantation (SCT).
Detailed Description
The primary objective of the study is to evaluate the Complete Remission (CR/CRi) rate after treatment with CPX-351 in patients with AML secondary to myeloproliferative neoplasms (post-MPN AML). The hypotheses made is that treatment with CPX-351 will improve the historical response rate from 45% to 65%. The exact single stage Phase II design was used to calculate the number of patients. The null hypothesis H0 is that the probability p of CR/CRi rate with CPX351 is equal or lower than the historical rate p0 of 45% (H0: p≤p0). The alternative hypothesis H1 that is p>p0, supposing that CR/CRi rate will be 65% using CPX351. Considering an alpha risk of 5% and a power of 80%, 42 patients will be included, and H0 will be rejected if at least 25 patients achieve CR /CRi (R-project, "clinfun" package). Inclusion period : 36 months Treatment period (6 months) : one or two cycles of induction treatment with CPX-351 (depending on CR/CRi achieving). If CR/CRi is not achieved following the induction phase, patients will go off study. 2 courses of consolidation therapy with CPX-351 (patients for whom an allo-SCT is planned will receive a maximum of one consolidation cycle) All included patients will be followed for 60 days after the End of Treatment (EOT) or at the date of allogeneic stem cell transplantation when appropriate : the day-60 follow-up visit will be the End Of Study (EOS) visit. The anti-leukemic chemotherapy administrated after relapse will be recorded. After completion of the study, subjects will be followed-up at regular intervals (every 3 months) to collect information on the subjects' survival and disease (relapse) status. Survival status will be collected until death, or withdrawal of consent or lost to follow-up, whichever occurs first..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Myeloproliferative Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Open label multicenter phase II non-randomized study
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPX351
Arm Type
Experimental
Arm Description
Induction : patients will receive induction treatment with CPX-351 100 U/m2 on days 1, 3, and 5. Patients who fail to achieve CR/CRi after the induction cycle will be offered a second induction course of CPX-351 100 U/m2 on days 1 and 3, at the investigators' discretion. If CR/CRi is not achieved following the second induction cycle, patients will go off study Consolidation : patients in CR/CRi after induction cycle will receive up to 2 course of CONSOLIDATION therapy with CPX-351 65 U/m2 on days 1 and 3. CPX351 doses could be reduced to 65 U/m2 on day 1 in case of unacceptable toxicity following the previous course.
Intervention Type
Drug
Intervention Name(s)
CPX-351
Intervention Description
Induction : patients will receive induction treatment with CPX-351 100 U/m2 on days 1, 3, and 5. Patients who fail to achieve CR/CRi after the induction cycle will be offered a second induction course of CPX-351 100 U/m2 on days 1 and 3, at the investigators' discretion. If CR/CRi is not achieved following the second induction cycle, patients will go off study Consolidation : patients in CR/CRi after induction cycle will receive up to 2 course of consolidation therapy with CPX-351 65 U/m2 on days 1 and 3. CPX351 doses could be reduced to 65 U/m2 on day 1 in case of unacceptable toxicity following the previous course. Allo-SCT : patients for whom an allo-SCT is planned will receive a maximum of one consolidation cycle
Primary Outcome Measure Information:
Title
Rate of CR/CRi after first induction therapy
Description
Rate of CR/CRi according to ELN2017 criteria
Time Frame
After 28 to 42 days after one cycle of 5 days of CPX351
Title
Rate of CR/CRi after second induction therapy
Description
Rate of CR/CRi according to ELN2017 criteria
Time Frame
If applicable, after 28 to 31 days after a second cycle of 3 days of CPX351

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of newly secondary AML according to WHO 2016 classification following an antecedent of Myeloproliferative Neoplasm including Essential Thrombocythemia (ET), Polycythemia Vera (PV), primary or secondary Myelofibrosis Performance status 2 Eastern Cooperative Oncology Group (ECOG) grading. Eligible for standard intensive chemotherapy Absence of concomitant severe cardiovascular disease which would make intensive chemotherapy impossible, i.e. arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease, reduced left ventricular function assessed by multigated acquisition (MUGA) scan or echocardiogram. Cardiac ejection fraction ≥ 50% by echocardiography ou MUGA Patient must have adequate organ function as indicated by the following laboratory values: Renal Serum creatinine: < 2 mg/dl OR calculated creatinine clearance*: ≥ 30 mL/min by MDRD formula for patients with creatinine levels > 1.5 X institutional Upper Limit Normal (ULN) Hepatic Serum total bilirubin: ≤ 2.5 X ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels ≥ 2 mg/dL unless Gilbert's Syndrome Aspartate-Amino-Transferase (ASAT) and Alanine-Transaminase (ALAT): ≤ 2.5 times ULN Alkaline Phosphatase: ≤ 5 X ULN, if > 2.5 X ULN, then liver fraction should be ≤ 2.5 X ULN *Creatinine clearance should be calculated per institutional standard Life expectancy should be of 12 weeks at least according to investigator evaluation Female patients of childbearing potential must have a negative serum pregnancy test (β-hCG) within 72 hours prior to receiving the first dose of CPX-351. Female patients who are not post-menopausal, free from menses for > 2 years or surgically sterilized, will have to use adequate barrier methods of contraception to prevent pregnancy or agree to abstain from becoming pregnant throughout the study, starting with Visit 1. Male patients agree to use an adequate method of contraception for the duration of the study. Men should be advised not to father a child while receiving CPX-351 and for 3 months post study. Patients have the ability to understand and willingness to sign an informed consent form indicating the investigational nature of the study. Exclusion Criteria: MPN/MDS mixed types Prior therapy for AML transformation except for Hydroxyurea Prior treatment with growth factors such as erythropoietin alfa (EPO) or granulocyte colony-stimulating factor (G-CSF), low-dose oral chemotherapy or Hypomethylating agents chemotherapy given in the chronic phase of MPN in the 30 days before inclusion, except for hydroxyurea. Uncontrolled undercurrent illness or circumstances that could limit compliance with the study, including but not limited to the following: symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, pancreatitis, or psychiatric or social conditions that may interfere with patient compliance. Active and uncontrolled infection Current participation or participation in a study with an investigational compound or device within 30 days of initial dosing with study drug Patients with acute promyelocytic leukemia. Known human immunodeficiency virus (HIV) infection or HIV-related malignancy Clinically active hepatitis B or hepatitis C infection. Known allergy or hypersensitivity to any component of CPX-351. Currently active second malignancy, other than non-melanoma skin cancer and in situ carcinoma of the cervix. Patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for >3 years or are considered by their physician to be at less than 30% risk of relapse Clinical evidence of Central Nervous System Leukemia. Pregnancy or breastfeeding during the projected duration of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valérie ROLLAND-NEYRET
Phone
(0)4 76 76 50 96
Ext
+33
Email
VRolland-neyret@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jérôme REY, MD
Organizational Affiliation
French Innovative Leukemia Organisation
Official's Role
Principal Investigator
Facility Information:
Facility Name
AMIENS - CHU Amiens Picardie
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delphine LEBON, MD
Email
lebon.delphine@chu-amiens.fr
Facility Name
ANGERS - CHU - Maladies du sang
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathilde HUNAULT, Dr
Phone
02 41 35 45 82
Email
mahunault@chu-angers.fr
Facility Name
AVIGNON - Centre Hospitalier
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
BAYONNE - CH de la Côte Basque - Hématologie
City
Bayonne
ZIP/Postal Code
64109
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Baptiste ROBIN, Dr
Email
jbrobin@ch-cotebasque.fr
Facility Name
AVICENNE - Centre de Recherche Clinique
City
Bobigny
ZIP/Postal Code
93009
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thorsten BRAUN, Pr
Email
thorsten.braun@aphp.fr
Facility Name
BREST - Hôpital Morvan
City
Brest
ZIP/Postal Code
29609
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaëlle GUILLERM, MD
Email
gaelle.guillerm@chu-brest.fr
Facility Name
CAEN - CHU Caen - IHBN
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain CHANTEPIE, Dr
Email
chantepie-s@chu-caen.fr
Facility Name
CLAMART - Hôpital d'Instruction des Armées de Percy
City
Clamart
ZIP/Postal Code
92140
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre ARNAUTOU, MD
Email
parnautou@yahoo.fr
Facility Name
Clermont-Ferrand - Chu Estaing
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romain Guieze, MD
Phone
+33473750766
Email
rguieze@chu-clermontferrand.fr
Facility Name
CRETEIL - CHU Henri Mondor
City
Créteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile PAUTAS, MD
Email
cecile.pautas@aphp.fr
Facility Name
Grenoble - CHUGA - Hématologie Clinique
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain CARRAS, Dr
Email
Scarras@chu-grenoble.fr
Facility Name
LILLE CHU - Hôpital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morgane NUDEL
Email
morgane.nudel@chru-lille.fr
Facility Name
LIMOGES - CHU Dupuytren 1
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nataliya DMYTRUC
Email
nataliya.dmytruk@chu-limoges.fr
Facility Name
LYON-Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amine BELHABRI, MD
Email
amine.belhabri@lyon.unicancer.fr
Facility Name
MARSEILLE - Institut Paoli-Calmettes
City
Marseille
ZIP/Postal Code
13000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérôme REY, Dr
Email
reyj@ipc.unicancer.fr
Facility Name
MONTPELLIER - 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
Eve GEHLKOPF, Dr
Email
e-gehlkopf@chu-montpellier.fr
Facility Name
NANTES - Hôpital Hôtel Dieu - Hématologie Clinique
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre PETERLIN, Dr
Phone
+33(0)2 40 08 32 71
Email
pierre.peterlin@chu-nantes.fr
Facility Name
NICE - Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauris GASTAUD, MD
Email
lauris.gastaud@nice.unicancer.fr
Facility Name
NICE - CHU - Hopital Archet 1
City
Nice
ZIP/Postal Code
06202
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas CLUZEAU
Email
cluzeau.t@chu-nice.fr
Facility Name
NIMES - CHU Caremeau
City
Nîmes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric JOURDAN, Dr
Phone
04 66 68 32 31
Email
eric.jourdan@chu-nimes.fr
Facility Name
ORLEANS - CHR - Hématologie
City
Orléans
ZIP/Postal Code
44100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magda ALEXIS, Dr
Email
magda.alexis@chr-orleans.fr
Facility Name
Paris St Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ollivier LEGRAND, Pr
Email
ollivier.legrand@aphp.fr
Facility Name
Paris Saint Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis DREVON, Pr
Email
louis.drevon@aphp.fr
Facility Name
BORDEAUX - Hôpital Haut-Levêque
City
Pessac
ZIP/Postal Code
33600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud PIGNEUX, Pr
Email
arnaud.pigneux@chu-bordeaux.fr
Facility Name
LYON HCL - CH Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69036
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuelle FERRAND, MD
Email
emmanuelle.ferrant2@chu-lyon.fr
Facility Name
POITIERS - Hôpital La Milétrie - Hématologie Clinique
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria-Pilar GALLEGO-HERNANZ, Dr
Phone
+33(0)5 49 44 44 44
Email
maria-pilar.gallego-hernanz@chu-poitiers.fr
Facility Name
REIMS - Hôpital Robert Debré - Hématologie Clinique
City
Reims
ZIP/Postal Code
51100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chantal HIMBERLIN, Dr
Phone
+33(0)3 26 78 36 44
Email
chimberlin@chu-reims.fr
Facility Name
RENNES - Hôpital Pontchaillou - Hématologie
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc BERNARD, Dr
Phone
+33(0)2 99 28 99 86
Email
marc.bernard@chu-rennes.fr
Facility Name
Strasbourg - Icans
City
Strasbourg
ZIP/Postal Code
67033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Pierre LEDOUX, MD
Email
mp.ledoux@icans.eu
Facility Name
Toulouse - IUCT Oncopole - Service d'Hématologie
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian RECHER, Pr
Phone
+33 5 31 15 63 55
Email
recher.christian@iuct-oncopole.fr
Facility Name
TOURS - Hôpital Bretonneau
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alban VILLATE, MD
Email
a.villate@chu-tours.fr
Facility Name
NANCY - CHU de Brabois
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline BONMATI, Dr
Email
c.bonmati@chru-nancy.fr
Facility Name
VERSAILLES - Hôpital André Mignot
City
Versailles
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Laure TAKSIN-BRESSOT, Dr
Email
altaksin@ch-versailles.fr
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence PASQUIER, MD
Email
florence.pasquier@gustaveroussy.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27742771
Citation
Courtier F, Carbuccia N, Garnier S, Guille A, Adelaide J, Cervera N, Gelsi-Boyer V, Mozziconacci MJ, Rey J, Vey N, Chaffanet M, Birnbaum D, Murati A. Genomic analysis of myeloproliferative neoplasms in chronic and acute phases. Haematologica. 2017 Jan;102(1):e11-e14. doi: 10.3324/haematol.2016.152363. Epub 2016 Oct 14. No abstract available.
Results Reference
background
PubMed Identifier
33206963
Citation
Luque Paz D, Jouanneau-Courville R, Riou J, et al. Leukemic evolution of polycythemia vera and essential thrombocythemia: genomic profiles predict time to transformation. Blood Adv. 2020;4(19):4887-4897. Blood Adv. 2020 Nov 24;4(22):5651. doi: 10.1182/bloodadvances.2020003711. No abstract available.
Results Reference
background

Learn more about this trial

Evaluation of CPX-351 Monotherapy in Acute Myeloid Leukemia Secondary to Myeloproliferative Neoplasm

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