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Vitamin A pre-allo-HSCT for the prevention of GvHD: results from a randomized phase II trial
Study design1
- Patients were eligible if their pre-allo-HSCT serum vitamin A levels were <75th centile of the normal range for age.
- In total, 80 patients aged ≥1 year old were enrolled, with 40 patients receiving a single oral dose of vitamin A (4,000 IU/kg) pre-allo-HSCT and 40 patients receiving a placebo.
- Two analyses were performed: anintent-to-treat analysis and an as-treated analysis.
- The primary endpoint was the incidence of acute GvHD (aGvHD) by Day 100 posttransplant.
Key findings1
During the intent-to-treat analysis, the incidence of Grade 1–4 aGvHD by Day 100 was 12.5% in the vitamin A cohort and 20% in the placebo cohort (p = 0.5). Figure 1 illustrates secondary endpoint findings for the cumulative incidence of GvHD.
Figure 1. Occurrence of GvHD in patients who received vitamin A pre-allo-HSCT vs placebo, in the intent-to-treat analyses*
aGvHD, acute graft-versus-host disease;
cGvHD, chronic graft-versus-host disease; CI, cumulative incidence; GI, gastrointestinal; allo-HSCT, allogeneic hematopoietic stem cell transplantation.
*Adapted from Khandelwal, et al.1
Data was gathered posttransplantation.
In the as-treated analysis, the incidence of Grade 1–4 aGvHD by Day 100 was 8% in the vitamin A cohort and 20% in the placebo cohort (p = 0.2). Below, Table 1 summarizes the cumulative incidence of GvHD in the as-treated analyses.
Table 1. Occurrence of GvHD in patients who received vitamin A pre-allo-HSCT vs placebo, in the ‘as treated’ analyses*
|
aGvHD, acute graft-versus-host disease; cGvHD, chronic graft-versus-host disease; CI, cumulative incidence; GI, gastrointestinal; allo-HSCT, allogeneic hematopoietic stem cell transplantation; SR, steroid-refractory. |
|||
|
CI, % |
Vitamin A |
Placebo |
p-value |
|---|---|---|---|
|
Acute Grade 2–4 GvHD by 180 days |
0 |
12.5 |
0.02 |
|
Acute GI GvHD by 180 days |
0 |
12.5 |
0.02 |
|
SR aGVHD by 180 days |
0 |
10 |
0.049 |
|
cGvHD at 1-year |
2.7 |
15.3 |
0.01 |
|
Key learnings1 |
|
References
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