NCT06508099

Brief Summary

The therapy under investigation is the addition of 300 000 IU of vitamin A and 100 000 IU of vitamin D before conditioning. The study will include patients with malignant diseases in hematologic response with indications for allogeneic transplantation with matched related or matched unrelated donor.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
12mo left

Started May 2024

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
May 2024May 2027

Study Start

First participant enrolled

May 15, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 18, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

July 12, 2024

Last Update Submit

July 29, 2024

Conditions

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaBiphenotypic Acute LeukemiaLymphoblastic LymphomaChronic Myeloid LeukemiaMyelodysplastic SyndromesMyeloprolipherative NeoplsmNon-hodgkin Lymphoma

Keywords

allogeneic hematopoietic transplantationvitamin Avitamin D

Outcome Measures

Primary Outcomes (1)

  • Cumulative incidence of gastrointestinal acute GVHD

    Cumulative incidence of patients with acute GVHD II-IV grade, competing risk is death, relapse and primary graft failure

    125 days

Secondary Outcomes (9)

  • Incidence of HSCT-associated adverse events

    125 days

  • Infectious complications

    125 days

  • Overall survival

    2 years

  • Event-free survival

    2 years

  • Overall cumulative incidence of acute GVHD grade II-IV

    125 days

  • +4 more secondary outcomes

Study Arms (2)

Vitamin supplementation

EXPERIMENTAL

vitamin A 300 000 IU and vitamin D 100 000 IU on days -14 to -8 before transplantation

Drug: Vitamin ADrug: Vitamin D3

Routine care

NO INTERVENTION

Routine care

Interventions

Vitamin ADRUG

300 000 IU single dose orally

Vitamin supplementation
Vitamin D3DRUG

100 000 IU single dose orally

Vitamin supplementation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis: acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, chronic myeloproliferative disease, chronic myeloid leukemia, lymphoblastic lymphoma, myeloma
  • Related compatible donor 10/10 HLA-matched or unrelated compatible donor 9-10/10 HLA-matched
  • Age ≥18 years
  • Absence of severe concomitant somatic diseases

You may not qualify if:

  • \- Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 normal;
  • respiratory failure more than 1 degree. or oxygen dependence
  • Unstable hemodynamics;
  • Karnofsky index less than 70%
  • Repeated allogeneic transplantation of hematopoietic cells;
  • Creatinine clearance below 60ml/min/1.73m2;
  • Severe cardiac pathology, including a decrease in ejection fraction less than \<50%, unstable angina, exertional angina of III-IV functional class, heart failure of III-IV functional class, arrhythmia grade V according to Lawn
  • Severe decrease in lung function, FEV1 \<50% or DLCO\<50% predicted
  • Pregnancy
  • Somatic or mental pathology that does not allow signing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RM Gorbacheva Research Institute

Saint Petersburg, 197022, Russia

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteLeukemia, Biphenotypic, AcuteLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMyelodysplastic SyndromesLymphoma, Non-Hodgkin

Interventions

Vitamin ACholecalciferol

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological FactorsCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Central Study Contacts

IVAN SERGEEVICH MOISEEV

CONTACT

+78123386265moisiv@mail.ru

Irina Сергеевич Bykova

CONTACT

+78123386617bmt-director@1spbgmu.ru

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice-director of RM Gorbacheva Research Institute

Study Record Dates

First Submitted

July 12, 2024

First Posted

July 18, 2024

Study Start

May 15, 2024

Primary Completion

May 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

Written study proposal to Pavlov University Ethical Committee.

Shared Documents
STUDY PROTOCOL
More information

Locations

RU(1)