Immunomodulatory Effect of Vitamin D in Allogenic Post-transplant (Alovita-1)

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hematopoietic Stem Cell Transplantation

Treatments: Drug: 5000IU/day of Vitamine D; Drug: 1000IU/day of Vitamine D

Study type: Interventional

Funder types: Other

Identifiers

NCT02600988

Alovita-1

Details and patient eligibility

About

The purpose of this study is to determine whether vitamin D is effective in the prevention of graft-versus-host-disease after completion of allogeneic transplant.

Full description

The allogeneic transplant of haematopoietic cell is the only treatment option for many malignant blood diseases. Unfortunately, the progression free survival and the quality of life of transplanted patients is limited due to the development of graft-versus-host-disease (GVHD).

The development of new prophylaxis strategies of GVHD based in the use of immunomodulator agents (allowing the generation of an immunotolerance state and avoiding the use of immunosuppression) is essential.

The GVHD is due to the cytotoxic effect of the donor lymphocytes T against healthy organs and tissues of the receptor. Calcineurin inhibitor combined with methotrexate or antibodies anti-lymphocytes T are used as standard prophylaxis. This type of antibodies has demonstrated efficacy to reduce GVHD, but have not increased survival due to increasing the risk of relapses and serious post-transplant infections.

Due to its interactions with VDR (vitamin D receptor) present in immune system cells, vitamin D is able to inhibit the activation of dendritic cells and the proliferation and production of cytokines by lymphocytes T. Based on this effect, the peri- and post- transplant administration of vitamin D might decrease the risk of GVHD in allogeneic transplanted patients, subsequently decreasing the immunosuppressant treatment requirements and improving the prognosis of those patients.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• The patient should accomplish all the criteria to proceed to an allogeneic transplant
• The patient or their legal guardians should signed the informed consent approved by the Ethics Committees of Clinical Trials

Exclusion criteria

• Hypercalcemia ≥ 10.5 mg/dl
• Renal insufficiency with creatinine level ≥ 2 x upper limit of normal (1,1 mg/dl)
• Participation in others Clinical Trials in which the intervention may affect the result of the study.
• Patients receiving GVHD immunoprophylaxis with thymoglobuline or GVHD prophylaxis including in vitro or in vivo lymphocytes T depletion (anti-lymphocyte T globulin, ALG)
• Patients receiving a transplant from an haploidentical donor

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Group 1: Control

No Intervention group

Description:

Control group is composed by the first 50 patients included in the study. Those patients will not receive the treatment. Evaluations and follow-up will be the same as in the other groups.

Group 2: 1000IU/day of Vitamine D

Experimental group

Description:

It is composed by the following 50 patients joining the study. They will take 1000 IU of vitamin D once a day.

Treatment:

Drug: 1000IU/day of Vitamine D

Group 3: 5000IU/day of Vitamine D

Experimental group

Description:

It is composed by the last 50 patients joining the study. They will take 5000 IU of vitamin D once a day.

Treatment:

Drug: 5000IU/day of Vitamine D