Clinical trial · Interventional
PROPHYLAXIS OF GVH IN ELDERLY PATIENTS RECEIVING HAPLOIDENTICAL ALLOGENIC HEMATOPOIETIC STEM CELL TRASNPLANTATION USE OF A LOW DOSE ANTI-LYMPHOCYTIC SERUM
REINFORCED PROPHYLAXIS OF GVH IN ELDERLY PATIENTS WITH HAEMATOLOGICAL MALIGNANCIES RECEIVING HAPLOIDENTICAL ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION: USE OF A LOW DOSE OF POST-ALLOGRAFT ANTI-LYMPHOCYTIC SERUM
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this trial is to evaluate the efficacy of GVH prophylaxis reinforced by low-dose Thymoglobulin administered at the end of aplasia after haploidentical allogeneic transplantation. Patients will receive a single infusion of Thymoglobulin at a dose of 1 mg/kg between 48h and 72h after emergence from aplasia, and will be followed for 12 months.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thymoglobulin Injectable Product | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Rate of acute GVH
- timeFrame
- Day 100
- description
- To assess the rate of grade 2-4 acute GVHD post allograft using the MAGIC classification.
Secondary outcomes (9)
- measure
- Acute GVH
- timeFrame
- day(D) 30, D60, D90, D100, D120, D180, D270 and D365
- description
- Grade 2-4 acute GVHD will be assessed using the MAGIC classification post allograft
- measure
- chronic GVH
- timeFrame
- day(D)100, D120, D180, D270 and D365
- description
- Chronic GVHD will be assessed using NIH classification post allograft,
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Adults aged ≥ 60 or aged 50 to 59 with comorbidities (HCT-CI10 score ≥ 3), * Hematological malignancies except myeloproliferative syndrome and myelodysplastic syndrome, * Patient having received an allograft within ≤ 35 days, performed with the following modalities: * First allogeneic transplant, * Haploidentical donor, * Peripheral stem cell transplant, * Non-myeloablative "Baltimore"-type conditioning, delivered as standard in routine care, as reported in the literature (fludarabine, cyclophosphamide, total body irradiation), * Standard GVHD prophylaxis in the context of haploidentical transplants (post-transplant cyclophosphamide, ciclosporin A and mycophenolate mofetil). * Patient discharged from aplasia within ≤ 35 days, * Signed informed consent form, * Affiliation with a social security. Exclusion Criteria: * Previous allogeneic or organ transplant, * Presence of signs of GVHD, * Contraindications to treatment with Thymoglobuline®, * Hypersensitivity to rabbit proteins or to any of the excipients listed in the "Composition" section of the summary of product characteristics, * Pregnant women or may become pregnant (without effective contraception) or breast-feeding, * Persons in emergency situations or unable to give informed consent form, * Adult with a legal protection measure (adult under guardianship, curatorship or safeguard of justice), * Unable to comply with medical follow-up for geographical, social or psychological reasons.
References
Publications (0)
Data not yet available