Acute Myeloid LeukemiaPhase 2FT-RIC-HAPLONCT07598110
FLUDARABINE-TREOSULFAN REDUCED INTENSITY CONDITIONING REGIMEN PRIOR HAPLOIDENTICAL STEM CELL TRANSPLANTATION WITH POST TRANSPLANTATION CYCLOPHOSPHAMIDE FOR OLDER AND/OR FRAIL PATIENTS WITH AML
A Phase 2 study testing fludarabine and treosulfan in people with Acute Myeloid Leukemia, run by Institut Paoli-Calmettes.
Trial summary
Acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS) predominantly affect older adults, and their incidence continues to rise with advanced age. For many patients, allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only curative option capable of providing long-term… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- fludarabine and treosulfan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2026to 10 Feb 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with age between 60 and 75 years old ; or aged 18-59 years if considered by the investigator for any reason as ineligible for MAC regimen (as defined by the EBMT criteria17), notably in case of HCT-CI ≥ 3 (patients planned by the investigators to receive a RIC regimen in clinical routine practice);
- Patients with AML according to the ELN2022 classification criteria requiring allo-HSCT including the MDS/AML sub category);
- Less than 5% bone marrow blast at the time of inclusion (i.e. CR, CRi, CRh, or MLFS after prior treatment, according to ELN 2022);
- Allo-HSCT planed with a haploidentical donor;
- Covered by a Healthcare System;
- Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements.
Who cannot join
- Left ventricular function < 40% ;
- Renal clearance < 50 mL/min ;
- Any severe uncontrolled medical condition considered by the investigator as a contraindication for using treosulfan;
- Pregnant women or those who may become pregnant (without effective contraception) or breastfeeding;
- Adults under legal protection (guardianship, curatorship, or judicial protection);
- Inability to comply with the medical follow-up of the trial for geographical, social, or psychological reasons.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: FLUDARABINE-TREOSULFAN REDUCED INTENSITY CONDITIONING REGIMEN PRIOR HAPLOIDENTICAL STEM CELL TRANSPLANTATION WITH POST TRANSPLANTATION CYCLOPHOSPHAMIDE FOR OLDER AND/OR FRAIL PATIENTS WITH AML: FT-RIC-HAPLO-IPC 2025-016
Acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS) predominantly affect older adults, and their incidence continues to rise with advanced age. For many patients, allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only curative option capable of providing long-term disease control through the graft-versus-leukemia (GVL) effect. Historically, however, allo-HSCT was rarely offered to patients older than 50 years because of the high morbidity and mortality associated with myeloablative conditioning regimens and limited supportive care strategies. Over the past two decades, advances in reduced-intensity conditioning (RIC), infection prophylaxis, and donor availability have profoundly transformed the landscape, allowing increasing numbers of older patients to access transplantation.
Multiple studies have demonstrated that allo-HSCT confers a survival benefit in older AML patients in complete remission compared with consolidation chemotherapy alone.
Read more
The intensity of conditioning profoundly influences both relapse risk and non-relapse mortality (NRM). myeloablative conditioning (NMAC) regimens are attractive for older adults due to their low toxicity but rely solely on the immunologic GVL effect and thus carry a higher relapse risk. Reduced-intensity conditioning (RIC) regimens, incorporating intermediate-dose alkylating agents such as busulfan, melphalan, or thiotepa, offer stronger anti-leukemic effect but at the cost of greater toxicity.
These observations underscore the central question: can a conditioning regimen combine strong anti-leukemic potency with the low toxicity required for older patients undergoing Haplo-SCT? The main objective is to evaluate the efficacy of FT-RIC regimen before Haplo-SCT for older and/or frail patients diagnosed with AML, who are not eligible for a myeloablative conditioning (MAC) regimen.
To achieve this objective, the investigators will assess Progression Free Survival (PFS) defined as the time from allo-HSCT to AML relapse or death.
This is a Multicenter trial, single arm prospective of phase II. Once the conditioning has been administered and the transplant performed, the patient will receive standard routine follow-up care, with the addition of questionnaires, and for patients followed at the Institut Paoli Calmettes only, blood samples will be collected.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- fludarabine and treosulfan
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fludarabine and treosulfanDrug
As per standard practices, patients will be hospitalized during the treatment period. The treatment is administered by the nurses of the department under the responsibility of the investigator.Fludarabine (30 mg/m²/day from day-6 to day-2), iv andTreosulfan (10 g/m²/day from day-4 to day-2), iv
| Study group | Role | What they receive |
|---|---|---|
| fludarabine and treosulfan | Experimental | After screening and inclusion, patients will be given a RIC regimen based on the market-approved association of fludarabine and treosulfan (FT-RIC):
* Fludarabine (concentrate for solution for injection/infusion) is a marketed purine analogue and antineoplastic agent.
* Treosulfan (powder for solution for infusion) is a marketed alkylating medication Receives: Drug: fludarabine and treosulfan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective is to evaluate the efficacy of FT-RIC regimen before Haplo-SCT for older and/or frail patients diagnosed with AML, who are not eligible for a MAC regimen.
Progression Free Survival (PFS) defined as the time from allo-HSCT to AML relapse or death
Measured: through study completion an average of 4 years
Secondary outcomes (6)
To evaluate adverse events related to the FT combination according to CTCAE V6.0
Conditioning related toxicity according to CTCAE V.6.0
Measured: through study completion an average of 4 years
To evaluate engraftment after FT-RIC
rate of graft failure
Measured: through study completion an average of 4 years
To evaluated hematological recovery after FT-RIC
Cumulative incidence of neutrophil and platelet recovery
Measured: after hematological recovery
to evaluate incidence of both acute and chronic GVHD after FT-RIC
Cumulative incidence of acute GVHD and Cumulative incidence of chronic GVHD
Measured: through study completion an average of 4 years
To evaluate survival, non-relapse mortality and cause of death after FT-RIC
Probability of Overall Survival and Probability of GVHD
Measured: through study completion an average of 4 years
To evaluate the immunosuppressive therapy duration after FT-RIC
Prevalence of immunosuppressive therapy (IST) and GVHD at 3, 6, 9, 12 months
Measured: through study completion an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start10 Oct 2026 (estimated)
- Primary completion10 Oct 2030 (estimated)
- Study completion10 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598110
- Sponsor's protocol ID
- FT-RIC-HAPLO-IPC 2025-016
- Other IDs
- 2025-523632-39-00, 2025
- Acronym
- FT-RIC-HAPLO
- Status last verified
- May 2026
- First submitted
- 27 Feb 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FLUDARABINE-TREOSULFAN REDUCED INTENSITY CONDITIONING REGIMEN PRIOR HAPLOIDENTICAL STEM CELL TRANSPLANTATION WITH POST TRANSPLANTATION CYCLOPHOSPHAMIDE FOR OLDER AND/OR FRAIL PATIENTS WITH AML: FT-RIC-HAPLO-IPC 2025-016
- ClinicalTrials.gov ID
- NCT07598110
- Acronym / sponsor ID
- FT-RIC-HAPLO / FT-RIC-HAPLO-IPC 2025-016
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 10 Oct 2030 (estimated)
- Study completion
- 10 Feb 2031 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS) predominantly affect older adults, and their incidence continues to rise with advanced age. For many patients, allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only curative option capable of providing long-term disease control through the graft-versus-leukemia (GVL) effect. Historically, however, allo-HSCT was rarely offered to patients older than 50 years because of the high morbidity and mortality associated with myeloablative conditioning regimens and limited supportive care strategies. Over the past two decades, advances in reduced-intensity conditioning (RIC), infection prophylaxis, and donor availability have profoundly transformed the landscape, allowing increasing numbers of older patients to access transplantation.
Multiple studies have demonstrated that allo-HSCT confers a survival benefit in older AML patients in complete remission compared with consolidation chemotherapy alone.
The intensity of conditioning profoundly influences both relapse risk and non-relapse mortality (NRM). myeloablative conditioning (NMAC) regimens are attractive for older adults due to their low toxicity but rely solely on the immunologic GVL effect and thus carry a higher relapse risk. Reduced-intensity conditioning (RIC) regimens, incorporating intermediate-dose alkylating agents such as busulfan, melphalan, or thiotepa, offer stronger anti-leukemic effect but at the cost of greater toxicity.
These observations underscore the central question: can a conditioning regimen combine strong anti-leukemic potency with the low toxicity required for older patients undergoing Haplo-SCT? The main objective is to evaluate the efficacy of FT-RIC regimen before Haplo-SCT for older and/or frail patients diagnosed with AML, who are not eligible for a myeloablative conditioning (MAC) regimen.
To achieve this objective, the investigators will assess Progression Free Survival (PFS) defined as the time from allo-HSCT to AML relapse or death.
This is a Multicenter trial, single arm prospective of phase II. Once the conditioning has been administered and the transplant performed, the patient will receive standard routine follow-up care, with the addition of questionnaires, and for patients followed at the Institut Paoli Calmettes only, blood samples will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fludarabine and treosulfan | Experimental | Drug: fludarabine and treosulfanAfter screening and inclusion, patients will be given a RIC regimen based on the market-approved association of fludarabine and treosulfan (FT-RIC): * Fludarabine (concentrate for solution for injection/infusion) is a marketed purine analogue and antineoplastic agent. * Treosulfan (powder for solution for infusion) is a marketed alkylating medication |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with age between 60 and 75 years old ; or aged 18-59 years if considered by the investigator for any reason as ineligible for MAC regimen (as defined by the EBMT criteria17), notably in case of HCT-CI ≥ 3 (patients planned by the investigators to receive a RIC regimen in clinical routine practice);
- Patients with AML according to the ELN2022 classification criteria requiring allo-HSCT including the MDS/AML sub category);
- Less than 5% bone marrow blast at the time of inclusion (i.e. CR, CRi, CRh, or MLFS after prior treatment, according to ELN 2022);
- Allo-HSCT planed with a haploidentical donor;
- Covered by a Healthcare System;
Key exclusion criteria (6 listed)
- Left ventricular function < 40% ;
- Renal clearance < 50 mL/min ;
- Any severe uncontrolled medical condition considered by the investigator as a contraindication for using treosulfan;
- Pregnant women or those who may become pregnant (without effective contraception) or breastfeeding;
- Adults under legal protection (guardianship, curatorship, or judicial protection);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fludarabine and treosulfanAs per standard practices, patients will be hospitalized during the treatment period. The treatment is administered by the nurses of the department under the responsibility of the investigator.Fludarabine (30 mg/m²/day from day-6 to day-2), iv andTreosulfan (10 g/m²/day from day-4 to day-2), iv | Drug | fludarabine and treosulfan |
Primary outcome
The main objective is to evaluate the efficacy of FT-RIC regimen before Haplo-SCT for older and/or frail patients diagnosed with AML, who are not eligible for a MAC regimen.
Time frame: through study completion an average of 4 years
Progression Free Survival (PFS) defined as the time from allo-HSCT to AML relapse or death
6 secondary outcomes
To evaluate adverse events related to the FT combination according to CTCAE V6.0
Time frame: through study completion an average of 4 years
To evaluate engraftment after FT-RIC
Time frame: through study completion an average of 4 years
To evaluated hematological recovery after FT-RIC
Time frame: after hematological recovery
to evaluate incidence of both acute and chronic GVHD after FT-RIC
Time frame: through study completion an average of 4 years
To evaluate survival, non-relapse mortality and cause of death after FT-RIC
Time frame: through study completion an average of 4 years
To evaluate the immunosuppressive therapy duration after FT-RIC
Time frame: through study completion an average of 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
Related trials for Acute Myeloid Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fludarabine and treosulfan in people with Acute Myeloid Leukemia, run by Institut Paoli-Calmettes.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PAKRADOUNI Jihane (0491223824, pakradounij@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main objective is to evaluate the efficacy of FT-RIC regimen before Haplo-SCT for older and/or frail patients diagnosed with AML, who are not eligible for a MAC regimen. (time frame: through study completion an average of 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.