BridgeMD
Compares treatment options for Acute Myeloid Leukemia in Remission
Official title Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT
ClinicalTrials.gov ID: NCT05917405
What this study is testing
What is Fludarabine?
Fludarabine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myeloid leukemia in remission.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- 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 \<...
- 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
You likely can't join if
- 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
See the full eligibility 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%) 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 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...
- 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...
- 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...
- 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%.
- 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...
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Participation to another treatment study during the last month or expected participation to another treatment study during participation to the FLUCLORIC study.
The study team makes the final eligibility decision.
Where it's taking place
- Nantes, Loire Atlantique, France
- Amiens, France
- Angers, France
- Besançon, France
- Bordeaux, France
- Brest, France
- Caen, France
- Clermont-Ferrand, France
- Créteil, France
- Grenoble, France
- Lille, France
- Limoges, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Nancy, France
- Paris, France
- Poitiers, France
- Rennes, France
- Saint-Etienne, France
+ 1 more site(s).
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 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nantes, Loire Atlantique, France; Amiens, France; Angers, France; Besançon, France; Bordeaux, France; Brest, France and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.