Trial Title:
Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT
NCT ID:
NCT05917405
Condition:
Acute Myeloid Leukemia in Remission
Conditions: Official terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Fludarabine
Busulfan
Clofarabine
Conditions: Keywords:
Acute Myeloid Leukemia
Clofarabine
fludarabine
reduced intensity conditioning regimen
allogeneic stem cells transplantation
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
30 mg/m2/day IV fludarabine for 5 days (day-6 to day-2)
Arm group label:
Comparator: FB2A2 arm
Intervention type:
Drug
Intervention name:
Busulfan
Description:
130 mg/m2/day IV busulfan once daily for 2 days (day -4 and -3)
Arm group label:
Comparator: FB2A2 arm
Arm group label:
Experimental: CloB2 arm
Intervention type:
Drug
Intervention name:
ATG
Description:
Thymoglobuline®: 2.5 mg/Kg/day IV for 2 consecutive days (day -2 and -1)
Arm group label:
Comparator: FB2A2 arm
Arm group label:
Experimental: CloB2 arm
Intervention type:
Drug
Intervention name:
Clofarabine
Description:
30 mg/m2/day IV clofarabine for 5 days (day-6 to day-2)
Arm group label:
Experimental: CloB2 arm
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU de Nantes
Address:
City:
Nantes
Zip:
44000
Country:
France
Status:
Recruiting
Contact:
Last name:
Patrice Chevallier, Pr
Phone:
0240083271
Email:
patrice.chevallier@chu-nantes.fr
Facility:
Name:
CHU Amiens
Address:
City:
Amiens
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Amandine CHARBONNIER, Dr
Phone:
0322455606
Email:
Charbonnier.amandine@chu-amiens.fr
Facility:
Name:
CHU Angers
Address:
City:
Angers
Country:
France
Status:
Recruiting
Contact:
Last name:
Sylvie FRANCOIS, Dr
Phone:
0241354472
Email:
Syfrancois@chu.angers.fr
Facility:
Name:
CHU Besançon
Address:
City:
Besançon
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Ana BERCEANU, Dr
Phone:
0381668232
Email:
aberceanu@chu-besancon.fr
Facility:
Name:
CHU Bordeaux
Address:
City:
Bordeaux
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Edouard FORCADE, Dr
Phone:
0557656511
Email:
Edouard.forcade@chu-bordeaux.fr
Facility:
Name:
CHU Brest
Address:
City:
Brest
Country:
France
Status:
Recruiting
Contact:
Last name:
Gaelle GUILLERM, Dr
Phone:
0298223395
Email:
Gaelle.guillerm@chu-brest.fr
Facility:
Name:
CRLC Caen
Address:
City:
Caen
Country:
France
Status:
Recruiting
Contact:
Last name:
Sylvain CHANTEPIE, Dr
Phone:
0231272073
Email:
chantepie-s@chu-caen.fr
Facility:
Name:
CHU Clermont-Ferrand
Address:
City:
Clermont-Ferrand
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Jacques-Olivier BAY, Pr
Phone:
0473750750
Email:
jobay@chu-clermontferrand.fr
Facility:
Name:
APHP Créteil
Address:
City:
Créteil
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Sebastien MAURY, Pr
Phone:
0149812059
Email:
sebastien.maury@aphp.fr
Facility:
Name:
CHU Grenoble
Address:
City:
Grenoble
Country:
France
Status:
Recruiting
Contact:
Last name:
Martin CARRE, Dr
Phone:
0476769445
Email:
MCarre@chu-grenoble.fr
Facility:
Name:
CHRU Lille
Address:
City:
Lille
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Valérie COITEUX, Dr
Phone:
0320445551
Email:
Valerie.coiteux@chu-lille.fr
Facility:
Name:
CHU Limoges
Address:
City:
Limoges
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Pascal TURLURE, Dr
Phone:
0555056642
Email:
Pascal.turlure@chu-limoges.fr
Facility:
Name:
CHU Lyon
Address:
City:
Lyon
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Helene LABUSSIERE-WALLET, Dr
Phone:
0472117402
Email:
helene.labussiere-wallet@chu-lyon.fr
Facility:
Name:
Institut Paoli Calmettes
Address:
City:
Marseille
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Raynier DEVILLIER, Dr
Phone:
0491223868
Email:
DEVILLIER@ipc.unicancer.fr
Facility:
Name:
CHU Montpellier
Address:
City:
Montpellier
Country:
France
Status:
Recruiting
Contact:
Last name:
Patrice CEBALLOS, Dr
Phone:
0467338079
Email:
p-ceballos@chu-montpellier.fr
Facility:
Name:
CHRU Nancy
Address:
City:
Nancy
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Marie-Therese RUBIO, Pr
Phone:
0383153030
Email:
M.RUBIO@chru-nancy.fr
Facility:
Name:
CHU Paris St-Louis
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Marie ROBIN, Dr
Phone:
0142499639
Email:
marie.robin@aphp.fr
Facility:
Name:
Pitie-Salpetriere, APHP
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Stéphanie NGUYEN, Pr
Phone:
0142162823
Email:
stephanie.nguyen-quoc@aphp.fr
Facility:
Name:
St-Antoine, APHP
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Mohamad MOHTY, Pr
Phone:
0149282620
Email:
Mohamad.mohty@inserm.fr
Facility:
Name:
CHU Poitiers
Address:
City:
Poitiers
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Natacha MAILLARD, Dr
Phone:
0549444472
Email:
natacha.maillard@chu-poitiers.fr
Facility:
Name:
CHU Rennes
Address:
City:
Rennes
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Jean-Baptiste MEAR, Dr
Phone:
0299284291
Email:
jeanbaptiste.mear@chu-rennes.fr
Facility:
Name:
CHU St-Etienne
Address:
City:
Saint-Étienne
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Jerome CORNILLON, Dr
Phone:
0477917000
Email:
Jerome.Cornillon@icloire.fr
Facility:
Name:
CRLC Toulouse
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Contact:
Last name:
Anne HUYNH, Dr
Phone:
0531155527
Email:
huynh.anne@iuct-oncopole.fr
Start date:
September 14, 2023
Completion date:
September 14, 2028
Lead sponsor:
Agency:
Nantes University Hospital
Agency class:
Other
Source:
Nantes University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05917405
