Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT
NCT ID: NCT05917405
Last Updated: 2023-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
302 participants
INTERVENTIONAL
2023-09-14
2028-09-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental: CloB2 arm
* 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
Busulfan
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)
Clofarabine
30 mg/m2/day IV clofarabine for 5 days (day-6 to day-2)
Comparator: FB2A2 arm
* 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)
Fludarabine
30 mg/m2/day IV fludarabine for 5 days (day-6 to day-2)
Busulfan
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)
Interventions
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Fludarabine
30 mg/m2/day IV fludarabine for 5 days (day-6 to day-2)
Busulfan
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)
Clofarabine
30 mg/m2/day IV clofarabine for 5 days (day-6 to day-2)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
99 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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patrice CHEVALLIER, Pr
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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CHU de Nantes
Nantes, Loire Atlantique, France
CHU Amiens
Amiens, , France
CHU Angers
Angers, , France
CHU Besançon
Besançon, , France
CHU Bordeaux
Bordeaux, , France
CHU Brest
Brest, , France
CRLC Caen
Caen, , France
CHU Clermont-Ferrand
Clermont-Ferrand, , France
APHP Créteil
Créteil, , France
CHU Grenoble
Grenoble, , France
CHRU Lille
Lille, , France
CHU Limoges
Limoges, , France
CHU Lyon
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
CHU Montpellier
Montpellier, , France
CHRU Nancy
Nancy, , France
CHU Paris St-Louis
Paris, , France
Pitie-Salpetriere, APHP
Paris, , France
St-Antoine, APHP
Paris, , France
CHU Poitiers
Poitiers, , France
CHU Rennes
Rennes, , France
CHU St-Etienne
Saint-Etienne, , France
CRLC Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RC22_0524
Identifier Type: -
Identifier Source: org_study_id
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