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Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT (FLUCLORIC)

Primary Purpose

Acute Myeloid Leukemia in Remission

Status
Not yet recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Fludarabine
Busulfan
ATG
Clofarabine
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia in Remission focused on measuring Acute Myeloid Leukemia, Clofarabine, fludarabine, reduced intensity conditioning regimen, allogeneic stem cells transplantation

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 years' old De novo or secondary AML (according to ELN 2022 classification) in complete cytological remission at time of transplant (bone marrow blast count < 5%) Patients in first or second line therapy are allowed Patient eligible to a RIC regimen : patients aged ≥ 60 year old or <60 with co-morbidity(ies). Patient with a related or an unrelated matched donor Graft using only peripheral blood stem cells Performance status ECOG 0 - 2 Who provide their written informed consent Previous allograft allowed Affiliated with French social security system or beneficiary from such system Women must meet one of the following criteria at the time of inclusion: use adequate contraceptive measures as recommended by the CTFG (Recommendations related to contraception and pregnancy testing in clinical trials v1.1; includes injectable implants, dual hormone birth control pills, intrauterine devices, abstinence from sex, or a sterilized partner), and have a negative pregnancy test (urine or serum pregnancy test) prior to receiving the first dose of study drug; or be post-menopausal (over 50 years of age with amenorrhea for at least 12 months after discontinuation of all exogenous hormonal therapy) or (if under 50 years of age) have been amenorrheic for at least 12 months after discontinuation of exogenous hormonal therapy and with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels corresponding to post-menopausal levels or have undergone irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy (this operation must be documented). Contraception methods must be prescribed using effective contraceptive methods during treatment and within 6 months for women of childbearing age (WOCB) and 6 months for men in case they have sexual relations with WOCB after the last dose of Fludarabine/Clofarabine. Exclusion Criteria: Pro-myelocytic leukemia Patient eligible to a myeloablative conditioning regimen Patient with haploidentical, mismatched unrelated donor or umbilical cord blood Pregnant or breastfeeding woman or patient refusing contraceptive mesures HIV positive Active Hepatitis B or C Left ventricular ejection fraction < 50%. DLCO <40% Uncontrolled infection Uncontrolled haemolytic anaemia Creatinine clearance < 50 ml/min (evaluated by MDRD or CKDEPI). Serum bilirubine < 30 mmol/l, Cytolysis >5 the upper limit range Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 2 years Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule Participation to another interventional study during the last month or expected participation to another interventional study during participation to the FLUCLORIC study.

Sites / Locations

  • CHU de Nantes
  • CHU Amiens
  • CHU Angers
  • CHU Besançon
  • CHU Bordeaux
  • CHU Brest
  • CRLC Caen
  • CHU Clermont-Ferrand
  • APHP Créteil
  • CHU Grenoble
  • CHRU Lille
  • CHU Limoges
  • CHU Lyon
  • Institut Paoli Calmettes
  • CHU Montpellier
  • CHRU Nancy
  • CHU Paris St-Louis
  • Pitie-Salpetriere, APHP
  • St-Antoine, APHP
  • CHU Poitiers
  • CHU Rennes
  • CHU St-Etienne
  • CRLC Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental: CloB2 arm

Comparator: FB2A2 arm

Arm Description

30 mg/m2/day IV clofarabine for 5 days (day-6 to day-2) 130 mg/m2/day IV busulfan once daily for 2 days (day -4 and -3) ATG (Thymoglobuline®) 2.5 mg/Kg/day IV for 2 consecutive days (day -2 and -1) Corticosteroids may be used in profilaxis

30 mg/m2/day IV fludarabine for 5 days (day-6 to day-2) 130 mg/m2/day IV busulfan once daily for 2 days (day -4 and -3) ATG (Thymoglobuline®) 2.5 mg/Kg/day IV for 2 consecutive days (day -2 and -1)

Outcomes

Primary Outcome Measures

To compare 2-year OS between patients with AML in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT.
OS is defined as the time from day 1 of conditioning to death or last follow-up for survivors.

Secondary Outcome Measures

To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT: Engraftment, primary and secondary graft failure
Engraftment: PNN >500/mm3 + donor chimerism >=5% (day +30/42) Primary and secondary graft failure: donor chimerism <5% at day +30/42 post-transplant (primary) or at distance of transplant after achieving engraftment (secondary)
To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT: Neutrophils and platelet recoveries
Neutrophils recovery: the first of three consecutive days with neutrophils ≥500/mm3 after aplasia from day 0 of the graft Platelets recovery: the first of three consecutive days with platelets ≥20000/mm3 without transfusion after aplasia from day 0 of the graft
To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT: 2-year DFS
DFS: time from day1 of the conditioning to time without death or evidence of relapse or disease progression censored at the date of last follow-up.
To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT:-2-year relapse incidence
Relapse: any event related to progression or re-occurrence of the disease from day 1 of the conditioning.
To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT:2-year NRM
NRM: death from any cause without previous relapse or progression from day 1 of the conditioning
To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT:Incidence of acute and chronic graft versus host disease (GVHD)
Acute GVHD: NIH criteria Chronic GVHD: NIH criteria
To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT:Incidence of GVHD free relapse free survival (GRFS)
GRFS: alive with no previous grade III-IV acute GvHD, no moderate or severe chronic GvHD and no relapse from day 1 of the conditioning
To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo SCT:Chimerism
Chimerism: peripheral blood and CD3 T cells by molecular markers at days +30, +60, +90/100
To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo- SCT:Immune reconstitution
Immune reconstitution: Immunophenotype of PB lymphocytes and EPP: CD4, CD8, B, NK, EPP at 3, 6, 9 and 12 months
To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo- SCT: Minimal residual disease (MRD)
Minimal residual disease (MRD): before transplant, at day +30 and day +90/100 by flow cytometry, molecular biology and NGS (if available) (ELN 2022 recommendation, Dohner et al Blood 2022)
Comparison of infections after FB2A2 vs CloB2A2: bacterial, viral, parasitic and fungal
Comparison of infections after FB2A2 vs CloB2A2: bacterial, viral, parasitic and fungal between day 0 and day+90/100
Quality of life using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)
Score of the QLQ-C30 questionnaire, including 30 questions assessing some aspects of the quality of life of cancer patients. The total score ranges from 0 to 100.
Quality of life using the and FACT-BMT (Functional Assessment of Cancer Therapy - Bone Marrow Transplant))
Score of the FACT-BMT questionnaire, including 50 questions assessing some aspects of the quality of life of cancer patients. The total score ranges from 0 to 200.
comparison of the cost of graft hospitalization between the 2 arms
Graft hospitalization cost: Comparison between both groups in terms of length of stay (in days), use of antibiotics (type and length in days)
comparison of the cost of graft hospitalization between the 2 arms
Graft hospitalization cost: Comparison between both groups in terms of blood products administered (numbers)
health benefit measurement in both treatment arms
General Health State with Euroqol EQ-5D-5L questionnaire at Days -7, 30, 90, 180, 360 and 720; 5 answers are possible.
Evaluation of economic efficiency of a CloB2A2 compared to a FB2A2 RIC regimen for allo-SCT, from a collective perspective (considering costs to the National Health Insurance system, hospital and patients)with a 24-month time horizon.
Health Economic study: Incremental cost-utility ratio (ICUR, cost per quality-adjusted life year [QALY] gained) and incremental cost-effectiveness ratio (ICER, cost per life year gained), from a collective perspective and with a 24-month time horizon
Comparison of Overall survival (OS) between patients in first vs second line therapy and impact of clofarabine vs fludarabine in each sub-group.
Comparison of time from D1 of conditioning to death or last follow-up for survivors
Comparison of DFS between patients in first vs second line therapy and impact of clofarabine vs fludarabine in each sub-group.
Comparison of time from day1 of the conditioning to time without death or evidence of relapse or disease progression censored at the date of last follow-up.
Comparison of Overall survival (OS) between patients receiving a first vs a second allograft and impact of clofarabine vs fludarabine in each sub-group.
Comparison of time from D1 of conditioning to death or last follow-up for survivors
Comparison of DFS between patients receiving a first vs a second allograft and impact of clofarabine vs fludarabine in each sub-group.
Comparison of time from day1 of the conditioning to time without death or evidence of relapse or disease progression censored at the date of last follow-up.
Comparison of occurence of Veno-occlusive disease between patients receiving clofarabine vs fludarabine.n day 0 and day+90/100
Comparison of occurrence of veno-occlusive disease : (Mohty et al, BMT 2016) betwee
Safety assessment
Safety assessment: the safety assessment shall be done by collecting all adverse events that occur during the research. All adverse event (except GvHD) shall be graded according to CTC-AE Toxicity Grading Scale (version 5).

Full Information

First Posted
May 16, 2023
Last Updated
June 15, 2023
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05917405
Brief Title
Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT
Acronym
FLUCLORIC
Official Title
FLUCLORIC: Randomized Multicentric Phase III Study Comparing the Efficacy of 2 Reduced Intensity Conditioning Regimens (Clofarabine/Busulfan vs Fludarabine/Busulfan) in Adults With AML and Eligible to Allogeneic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2028 (Anticipated)
Study Completion Date
July 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Relapse remains the main cause of death in patients with myeloid malignancies, especially after an allotransplant. Using drugs with higher anti-leukemic activity as part of the conditioning regimen is one of the strategies to decrease relapse incidence in this population. Retrospective studies have shown that clofarabine can achieve impressive results compared to the use of fludarabine in acute myeloid leukemia (AML) as part of the conditioning regimen. Confirming such results in a prospective manner would definitely establish the CloB2A2 as a superior reduced-intensity conditioning (RIC) regimen compared to the FB2A2 for AML patients.302 AML patients (151 in each arm) in complete remission at transplant will be included with the main objective to demonstrate a significant better 2-year overall survival for CloB2A2 cases (70% vs 55%). A cost-utility analysis and a cost-effectiveness analysis will be also performed as well as an assessment of the quality of life after transplant. Clofarabine will be furnished to all centers. The duration of the study will be 5 years with 3 years of inclusion and 2 years of follow-up for each patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia in Remission
Keywords
Acute Myeloid Leukemia, Clofarabine, fludarabine, reduced intensity conditioning regimen, allogeneic stem cells transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
302 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: CloB2 arm
Arm Type
Experimental
Arm Description
30 mg/m2/day IV clofarabine for 5 days (day-6 to day-2) 130 mg/m2/day IV busulfan once daily for 2 days (day -4 and -3) ATG (Thymoglobuline®) 2.5 mg/Kg/day IV for 2 consecutive days (day -2 and -1) Corticosteroids may be used in profilaxis
Arm Title
Comparator: FB2A2 arm
Arm Type
Active Comparator
Arm Description
30 mg/m2/day IV fludarabine for 5 days (day-6 to day-2) 130 mg/m2/day IV busulfan once daily for 2 days (day -4 and -3) ATG (Thymoglobuline®) 2.5 mg/Kg/day IV for 2 consecutive days (day -2 and -1)
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
30 mg/m2/day IV fludarabine for 5 days (day-6 to day-2)
Intervention Type
Drug
Intervention Name(s)
Busulfan
Intervention Description
130 mg/m2/day IV busulfan once daily for 2 days (day -4 and -3)
Intervention Type
Drug
Intervention Name(s)
ATG
Intervention Description
Thymoglobuline®: 2.5 mg/Kg/day IV for 2 consecutive days (day -2 and -1)
Intervention Type
Drug
Intervention Name(s)
Clofarabine
Intervention Description
30 mg/m2/day IV clofarabine for 5 days (day-6 to day-2)
Primary Outcome Measure Information:
Title
To compare 2-year OS between patients with AML in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT.
Description
OS is defined as the time from day 1 of conditioning to death or last follow-up for survivors.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT: Engraftment, primary and secondary graft failure
Description
Engraftment: PNN >500/mm3 + donor chimerism >=5% (day +30/42) Primary and secondary graft failure: donor chimerism <5% at day +30/42 post-transplant (primary) or at distance of transplant after achieving engraftment (secondary)
Time Frame
day +30/42 and 2 years
Title
To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT: Neutrophils and platelet recoveries
Description
Neutrophils recovery: the first of three consecutive days with neutrophils ≥500/mm3 after aplasia from day 0 of the graft Platelets recovery: the first of three consecutive days with platelets ≥20000/mm3 without transfusion after aplasia from day 0 of the graft
Time Frame
2 years
Title
To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT: 2-year DFS
Description
DFS: time from day1 of the conditioning to time without death or evidence of relapse or disease progression censored at the date of last follow-up.
Time Frame
2 years
Title
To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT:-2-year relapse incidence
Description
Relapse: any event related to progression or re-occurrence of the disease from day 1 of the conditioning.
Time Frame
2 years
Title
To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT:2-year NRM
Description
NRM: death from any cause without previous relapse or progression from day 1 of the conditioning
Time Frame
2 years
Title
To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT:Incidence of acute and chronic graft versus host disease (GVHD)
Description
Acute GVHD: NIH criteria Chronic GVHD: NIH criteria
Time Frame
Day 90 and 2 years
Title
To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT:Incidence of GVHD free relapse free survival (GRFS)
Description
GRFS: alive with no previous grade III-IV acute GvHD, no moderate or severe chronic GvHD and no relapse from day 1 of the conditioning
Time Frame
2 years
Title
To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo SCT:Chimerism
Description
Chimerism: peripheral blood and CD3 T cells by molecular markers at days +30, +60, +90/100
Time Frame
days +30, +60, +90
Title
To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo- SCT:Immune reconstitution
Description
Immune reconstitution: Immunophenotype of PB lymphocytes and EPP: CD4, CD8, B, NK, EPP at 3, 6, 9 and 12 months
Time Frame
3, 6, 9 and 12 months
Title
To compare between AML patients in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo- SCT: Minimal residual disease (MRD)
Description
Minimal residual disease (MRD): before transplant, at day +30 and day +90/100 by flow cytometry, molecular biology and NGS (if available) (ELN 2022 recommendation, Dohner et al Blood 2022)
Time Frame
days +30 and +90
Title
Comparison of infections after FB2A2 vs CloB2A2: bacterial, viral, parasitic and fungal
Description
Comparison of infections after FB2A2 vs CloB2A2: bacterial, viral, parasitic and fungal between day 0 and day+90/100
Time Frame
day+90
Title
Quality of life using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)
Description
Score of the QLQ-C30 questionnaire, including 30 questions assessing some aspects of the quality of life of cancer patients. The total score ranges from 0 to 100.
Time Frame
Days -7, +30, +90, +180 and +360
Title
Quality of life using the and FACT-BMT (Functional Assessment of Cancer Therapy - Bone Marrow Transplant))
Description
Score of the FACT-BMT questionnaire, including 50 questions assessing some aspects of the quality of life of cancer patients. The total score ranges from 0 to 200.
Time Frame
Days -7, +30, +90, +180 and +360
Title
comparison of the cost of graft hospitalization between the 2 arms
Description
Graft hospitalization cost: Comparison between both groups in terms of length of stay (in days), use of antibiotics (type and length in days)
Time Frame
2 years
Title
comparison of the cost of graft hospitalization between the 2 arms
Description
Graft hospitalization cost: Comparison between both groups in terms of blood products administered (numbers)
Time Frame
2 years
Title
health benefit measurement in both treatment arms
Description
General Health State with Euroqol EQ-5D-5L questionnaire at Days -7, 30, 90, 180, 360 and 720; 5 answers are possible.
Time Frame
Days -7, +30, +90, +180, +360 and +720.
Title
Evaluation of economic efficiency of a CloB2A2 compared to a FB2A2 RIC regimen for allo-SCT, from a collective perspective (considering costs to the National Health Insurance system, hospital and patients)with a 24-month time horizon.
Description
Health Economic study: Incremental cost-utility ratio (ICUR, cost per quality-adjusted life year [QALY] gained) and incremental cost-effectiveness ratio (ICER, cost per life year gained), from a collective perspective and with a 24-month time horizon
Time Frame
2 years
Title
Comparison of Overall survival (OS) between patients in first vs second line therapy and impact of clofarabine vs fludarabine in each sub-group.
Description
Comparison of time from D1 of conditioning to death or last follow-up for survivors
Time Frame
2 years
Title
Comparison of DFS between patients in first vs second line therapy and impact of clofarabine vs fludarabine in each sub-group.
Description
Comparison of time from day1 of the conditioning to time without death or evidence of relapse or disease progression censored at the date of last follow-up.
Time Frame
2 years
Title
Comparison of Overall survival (OS) between patients receiving a first vs a second allograft and impact of clofarabine vs fludarabine in each sub-group.
Description
Comparison of time from D1 of conditioning to death or last follow-up for survivors
Time Frame
2 years
Title
Comparison of DFS between patients receiving a first vs a second allograft and impact of clofarabine vs fludarabine in each sub-group.
Description
Comparison of time from day1 of the conditioning to time without death or evidence of relapse or disease progression censored at the date of last follow-up.
Time Frame
2 years
Title
Comparison of occurence of Veno-occlusive disease between patients receiving clofarabine vs fludarabine.n day 0 and day+90/100
Description
Comparison of occurrence of veno-occlusive disease : (Mohty et al, BMT 2016) betwee
Time Frame
day+90
Title
Safety assessment
Description
Safety assessment: the safety assessment shall be done by collecting all adverse events that occur during the research. All adverse event (except GvHD) shall be graded according to CTC-AE Toxicity Grading Scale (version 5).
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years' old De novo or secondary AML (according to ELN 2022 classification) in complete cytological remission at time of transplant (bone marrow blast count < 5%) Patients in first or second line therapy are allowed Patient eligible to a RIC regimen : patients aged ≥ 60 year old or <60 with co-morbidity(ies). Patient with a related or an unrelated matched donor Graft using only peripheral blood stem cells Performance status ECOG 0 - 2 Who provide their written informed consent Previous allograft allowed Affiliated with French social security system or beneficiary from such system Women must meet one of the following criteria at the time of inclusion: use adequate contraceptive measures as recommended by the CTFG (Recommendations related to contraception and pregnancy testing in clinical trials v1.1; includes injectable implants, dual hormone birth control pills, intrauterine devices, abstinence from sex, or a sterilized partner), and have a negative pregnancy test (urine or serum pregnancy test) prior to receiving the first dose of study drug; or be post-menopausal (over 50 years of age with amenorrhea for at least 12 months after discontinuation of all exogenous hormonal therapy) or (if under 50 years of age) have been amenorrheic for at least 12 months after discontinuation of exogenous hormonal therapy and with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels corresponding to post-menopausal levels or have undergone irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy (this operation must be documented). Contraception methods must be prescribed using effective contraceptive methods during treatment and within 6 months for women of childbearing age (WOCB) and 6 months for men in case they have sexual relations with WOCB after the last dose of Fludarabine/Clofarabine. Exclusion Criteria: Pro-myelocytic leukemia Patient eligible to a myeloablative conditioning regimen Patient with haploidentical, mismatched unrelated donor or umbilical cord blood Pregnant or breastfeeding woman or patient refusing contraceptive mesures HIV positive Active Hepatitis B or C Left ventricular ejection fraction < 50%. DLCO <40% Uncontrolled infection Uncontrolled haemolytic anaemia Creatinine clearance < 50 ml/min (evaluated by MDRD or CKDEPI). Serum bilirubine < 30 mmol/l, Cytolysis >5 the upper limit range Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 2 years Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule Participation to another interventional study during the last month or expected participation to another interventional study during participation to the FLUCLORIC study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrice CHEVALLIER, Pr
Email
patrice.chevallier@chu-nantes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
MARION GAUTIER
Email
marion.gautier@chu-nantes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
patrice CHEVALLIER, Pr
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nantes
City
Nantes
State/Province
Loire Atlantique
ZIP/Postal Code
44000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrice Chevallier, Pr
Phone
0240083271
Email
patrice.chevallier@chu-nantes.fr
Facility Name
CHU Amiens
City
Amiens
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amandine CHARBONNIER, Dr
Phone
0322455606
Email
Charbonnier.amandine@chu-amiens.fr
Facility Name
CHU Angers
City
Angers
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvie FRANCOIS, Dr
Phone
0241354472
Email
Syfrancois@chu.angers.fr
Facility Name
CHU Besançon
City
Besançon
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana BERCEANU, Dr
Phone
0381668232
Email
aberceanu@chu-besancon.fr
Facility Name
CHU Bordeaux
City
Bordeaux
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edouard FORCADE, Dr
Phone
0557656511
Email
Edouard.forcade@chu-bordeaux.fr
Facility Name
CHU Brest
City
Brest
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaelle GUILLERM, Dr
Phone
0298223395
Email
Gaelle.guillerm@chu-brest.fr
Facility Name
CRLC Caen
City
Caen
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain CHANTEPIE, Dr
Phone
0231272073
Email
chantepie-s@chu-caen.fr
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques-Olivier BAY, Pr
Phone
0473750750
Email
jobay@chu-clermontferrand.fr
Facility Name
APHP Créteil
City
Créteil
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastien MAURY, Pr
Phone
0149812059
Email
sebastien.maury@aphp.fr
Facility Name
CHU Grenoble
City
Grenoble
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin CARRE, Dr
Phone
0476769445
Email
MCarre@chu-grenoble.fr
Facility Name
CHRU Lille
City
Lille
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valérie COITEUX, Dr
Phone
0320445551
Email
Valerie.coiteux@chu-lille.fr
Facility Name
CHU Limoges
City
Limoges
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal TURLURE, Dr
Phone
0555056642
Email
Pascal.turlure@chu-limoges.fr
Facility Name
CHU Lyon
City
Lyon
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helene LABUSSIERE-WALLET, Dr
Phone
0472117402
Email
helene.labussiere-wallet@chu-lyon.fr
Facility Name
Institut Paoli Calmettes
City
Marseille
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raynier DEVILLIER, Dr
Phone
0491223868
Email
DEVILLIER@ipc.unicancer.fr
Facility Name
CHU Montpellier
City
Montpellier
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrice CEBALLOS, Dr
Phone
0467338079
Email
p-ceballos@chu-montpellier.fr
Facility Name
CHRU Nancy
City
Nancy
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Therese RUBIO, Pr
Phone
0383153030
Email
M.RUBIO@chru-nancy.fr
Facility Name
CHU Paris St-Louis
City
Paris
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie ROBIN, Dr
Phone
0142499639
Email
marie.robin@aphp.fr
Facility Name
Pitie-Salpetriere, APHP
City
Paris
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphanie NGUYEN, Pr
Phone
0142162823
Email
stephanie.nguyen-quoc@aphp.fr
Facility Name
St-Antoine, APHP
City
Paris
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamad MOHTY, Pr
Phone
0149282620
Email
Mohamad.mohty@inserm.fr
Facility Name
CHU Poitiers
City
Poitiers
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natacha MAILLARD, Dr
Phone
0549444472
Email
natacha.maillard@chu-poitiers.fr
Facility Name
CHU Rennes
City
Rennes
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste MEAR, Dr
Phone
0299284291
Email
jeanbaptiste.mear@chu-rennes.fr
Facility Name
CHU St-Etienne
City
Saint-Étienne
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerome CORNILLON, Dr
Phone
0477917000
Email
Jerome.Cornillon@icloire.fr
Facility Name
CRLC Toulouse
City
Toulouse
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne HUYNH, Dr
Phone
0531155527
Email
huynh.anne@iuct-oncopole.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT

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