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[Preprint]. 2023 Nov 10:rs.3.rs-3538792.
doi: 10.21203/rs.3.rs-3538792/v1.

Intravenous Vitamin C Supplementation in Allogeneic Hematopoietic Cell Transplant Recipients: Salutary Impact on Clinical Outcomes

Amir Toor  1 , Gary Simmons  1 , Roy Sabo, May Aziz  2 , Erika Martin  2 , Robyn Bernard  3 , Manjari Sriparna  3 , Cody McIntire  3 , Elizabeth Kreiger  3 , Donald Brophy  3 , Ramesh Natarajan  3 , Alpha Fowler, Catherine Roberts  3
Affiliations

Intravenous Vitamin C Supplementation in Allogeneic Hematopoietic Cell Transplant Recipients: Salutary Impact on Clinical Outcomes

Amir Toor et al. Res Sq. .

Update in

Abstract

Intravenous (IV) vitamin C improves organ function and reduces inflammation in sepsis, an inflammatory state like the post-hematopoietic stem cell transplant (HCT) milieu. The safety and efficacy of parenteral vitamin C after allogeneic HCT were evaluated in a phase I/II trial. Clinical outcomes were compared with a propensity score - matched historical control.

Methods: Patients with advanced hematologic malignancies received IV vitamin C, 50mg/kg/d, divided into 3 doses given on days 1-14 after HCT, followed by 500 mg bid oral from day 15 until 6 months post-SCT.

Results: 55 patients received IV vitamin C. All patients were deficient in vitamin C at day 0. Vitamin C recipients had lower non-relapse mortality (NRM) (p = 0.07) and improved survival compared to historical controls (p=0.06), with no attributable grade 3 and 4 toxicities. Vitamin C recipients had similar relapse rate and acute graft versus host disease (GVHD) (p=0.35), but lower severe chronic GVHD (p=0.35). Patients with myeloid malignancies had improved survival (p=0.02) and NRM (p=0.009), as well as chronic GVHD, with similar relapse rates compared to controls.

Conclusions: In patients undergoing allogeneic HCT the administration of IV vitamin C is safe and reduces non-relapse mortality and chronic GVHD improving overall survival.

Keywords: Parenteral ascorbic acid; allogeneic stem cell transplantation; graft vs. host disease; myeloid malignancy; non-relapse mortality.

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Conflict of interest statement

Conflict of Interest: The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
(A) CI curves depicting lower NRM in the VC treated patient. (B) In a multivariate model this was not significant (HR = 0.4, 95% CI: 0.1, 1.0, p-value = 0.069)
Figure 2
Figure 2
(A) KM curves depicting improved survival in the VC treated patients (p= 0.057). (B) In a multivariate model, only donor type (MUD vs. MRD: HR = 3.3, 95% CI: 1.1, 10.0, p = 0.032) and diagnosis (AML vs. ALL: HR = 7.75, 95% CI: 1.2, 50.2, p = 0.031) were significant.
Figure 3
Figure 3
(A) KM curves depicting improved survival in the VC treated patients with myeloid malignancies (p= 0.0167). (B) In a multivariate model this relationship remained significant (HR = 0.32, 95% CI: 0.12, 0.84, p-value = 0.02) amongst myeloid malignancy patient
Figure 4
Figure 4
(A) CI curves depicting lower NRM in the VC treated patients with myeloid malignancies. (B) In a multivariate model this was significant (HR = 0.22, 95% CI: 0.07, 0.69, p-value = 0.009)
Figure 5
Figure 5
(A) Vitamin C levels in the entire cohort of patients. (B) CRP levels at the same time points.
See this image and copyright information in PMC

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