A Phase 2 interventional study of Thymoglobulin Injectable Product in Hematological Malignancy, sponsored by Institut Paoli-Calmettes. Not yet recruiting. Open to participants aged 60 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by Institut Paoli-Calmettes · Phase 2, Interventional, and Prevention
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.
9,371 studies on the registry are indexed under Neoplasms; 2,492 are open to participants now.
This study's planned enrollment of 27 is below the median of 50 across 7,258 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Institut Paoli-Calmettes is the lead sponsor of 168 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient having received an allograft within ≤ 35 days, performed with the following modalities:
Exclusion Criteria:
single intravenous injection of thymoglobulin
Rate of acute GVH
To assess the rate of grade 2-4 acute GVHD post allograft using the MAGIC classification.
Time frame: Day 100
Acute GVH
Grade 2-4 acute GVHD will be assessed using the MAGIC classification post allograft
Time frame: day(D) 30, D60, D90, D100, D120, D180, D270 and D365
chronic GVH
Chronic GVHD will be assessed using NIH classification post allograft,
Time frame: day(D)100, D120, D180, D270 and D365
Cumulative incidence of chronic GVH
Cumulative incidence of chronic GVHD at 1 year post-transplant,
Time frame: 1 year
Cumulative incidence of NRM
Cumulative incidence of NRM at 1 year post-transplant,
Time frame: 1 year
Cumulative incidence of relapse
Cumulative incidence of relapse at 1 year post-transplant,
Time frame: 1 year
Immunology
Blood T, B and NK lymphocyte counts post-transplant,
Time frame: day(D)100, D120, D180, D270 and D365
Viral infections
Cumulative incidence of invasive fungal and viral infections (CMV, EBV, BK virus) post allograft,
Time frame: between day (D)30 and D120
Cumulative incidence
Cumulative incidence of EBMT-defined "poor graft function" post-transplant.
Time frame: Day 100
Survival
Progression-free survival and overall survival at 1 year post-transplant,
Time frame: 1 year
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Institut Paoli-Calmettes