Status:
NOT_YET_RECRUITING
Phase III Study Comparing GVHD Prophylaxis With ATG-thymoglobulin to ATLG-grafalon in Elderly Patients With Acute Myeloid Leukemia or Myelodysplasic Syndrome and Receiving an Allogeneic Hematopoietic Stem Cell Transplantation With a 10/10 HLA Matched Unrelated Donor
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
GVHD
Eligibility:
All Genders
50-70 years
Phase:
PHASE3
Brief Summary
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only curative therapy in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Most of the patients requiring an a...
Eligibility Criteria
Inclusion
- Age ≥ 50 and ≤ 70 years
- Patient between 50 and 55 years should be unfit for a myeloblative conditioning (SORROR score ≥2)
- AML requiring allogeneic stem cell transplantation (intermediate or high-risk AML) in complete cytologic response (CR1 or above) or MDS requiring allogeneic stem cell transplantation (IPSS≥ 1.5 or IPSS-R \> 4.5 or IPSS-R \> 3-4.5 with risk features \[rapide blast increase, life-threatening neutropenia (\<0.3 G/L) or thrombopenia (\<30G/L) or high transfusion needs (\>2/month for 6 months)\]
- Without an HLA matched related donor
- Having an identified matched HLA 10/10 unrelated donor
- With usual criteria for HSCT:
- ECOG performans status ≤ 2
- No severe and uncontrolled infection
- Cardiac left ventricular ejection fraction ≥50%
- Lung DLCO \> 40%
- Adequate organ function: ASAT and ALAT ≤ 3N, total bilirubin ≤ 2N, creatinine clearance ≥ 50 mL/min (except if those abnormalities are linked to the hematological disease)
- With health insurance coverage
- Having signed a written informed consent
- Contraception methods must be prescribed during all the duration of the research
- NB: The authorized contraceptive methods are:
- For women of childbearing age and in absence of permanent sterilization: oral, intravaginal or transdermal combined hormonal contraception, oral, injectable or transdermal progestogen-only hormonal contraception, intrauterine hormonal releasing system (IUS), sexual abstinence (only if this the preferred and usual lifestyle of the participants).
- For man in absence of permanent sterilization: sexual abstinence, condoms
Exclusion
- Cancer in the last 5 years (except basal cell carcinoma of the skin or "in situ" carcinoma of the cervix)
- Uncontrolled infection
- Seropositivity for HIV or HTLV-1 or active hepatitis B or C
- Yellow fever vaccine and all others live virus vaccines within 2 months before transplantation
- Heart failure according to NYHA (II or more) or Left ventricular ejection fraction \< 50%.
- Lung DLCO ≤ 40%
- Preexisting acute hemorrhagic cystitis
- Renal failure with creatinine clearance \< 50ml / min
- Pregnancy (β-HCG positive) or breast-feeding
- Patients with any debilitating medical or psychiatric illness, which would preclude the realization of the SCT or the understanding of the protocol
- Patient under state medical aid
- Patient under legal protection (protection of the court, or in curatorship or guardianship).
- For Grafalon: Hypersensitivity to the active substance or to any of the excipients
- For Thymoglobulin: Hypersensitivity to rabbit proteins or to any of the excipients
- Participation in other interventional clinical trials
- Any contraindication mentioned in the SmPC of all auxiliary medicinal products planned to be used in the trial: cyclosporine, mycophenolate mofetil, fludarabine, treosulfan
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT06083129
Start Date
November 1 2023
End Date
November 1 2028
Last Update
October 13 2023
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.