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FLUCLORIC - Randomized multicentric Phase III study comparing the efficacy of two reduced intensity conditioning regimens (clofarabine/busulfan versus fludarabine/busulfan) in adults with acute myeloid leukemia and eligible to allogeneic stem cell transplantation: a SFGM-TC study
EU CTIS ID: 2022-502019-12-00
What this study is testing
To compare 2-year OS between patients with AML in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years’ old
- 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.
- De novo or secondary AML in complete cytological remission at time of transplant (bone marrow blast count < 5%) or MDS/LAM with 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 year old with co-morbidity(ies).
You likely can't join if
- Pro-myelocytic leukemia
- HIV positive
- Active Hepatitis B or C
- Left ventricular ejection fraction < 50%
- DLCOc <40%
- Uncontrolled infection
See the full eligibility criteria
Who can join
- Age ≥ 18 years’ old
- 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.
- De novo or secondary AML in complete cytological remission at time of transplant (bone marrow blast count < 5%) or MDS/LAM with 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 year old 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
What rules you out
- Pro-myelocytic leukemia
- HIV positive
- Active Hepatitis B or C
- Left ventricular ejection fraction < 50%
- DLCOc <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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.