Acute Lymphoblastic LeukemiaPhase 2VitaStemNCT06508099
Vitamin A and D Supplementation in Allogeneic HCT
A Phase 2 study testing Vitamin A and Vitamin D3 in people with Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Biphenotypic Acute Leukemia
- What is being tested?
- Vitamin A and Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteRussia
- Study dates
- 15 May 2024to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis: acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, chronic myeloproliferative disease, chronic myeloid leukemia, lymphoblastic lymphoma, myeloma
- Standard disease risk: less than 5% clonal blasts in the bone marrow and the absence of blast forms in the peripheral blood at the time of inclusion in the study or at least partial response for lymphoproliferative neoplasms.
- 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
Who cannot join
- - 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;
- Uncontrolled bacterial or fungal infection at the time of inclusion, despite adequate antibacterial or antifungal therapy (CRP>70 mg/l at the time of inclusion).
- Karnofsky index less than 70%
- Repeated allogeneic transplantation of hematopoietic cells;
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
RM Gorbacheva Research Institute
Saint Petersburg, 197022
Ivan Moiseev, +79217961951, moisiv@mail.ru
Alexandr Kulagin, +78123386265, bmt-director@1spbgmu.ru
About this study
Official title: Randomized Study of Vitamin A and D Prophylaxis Before Allogeneic Related and Unrelated Hematopoietic Stem Cell Transplantation
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.
Read the detailed description
Currently there is an emerging evidence of gut microbiota role in major complications of HCT, including GVHD, oral mucositis, infectious complications due to multi-drug resistant bacteria in the gut. Early exhaustion of most intestinal bacterial phyla after HSCT is documented in many studies. This effect of intensive anti-infectious therapy is well known. Most authors explain the disruption of intestinal microbiota by massive antibiotic treatment in order to prevent infectious complications due to immune deficiency following HCT. Early decrease in anaerobic bacteria (phylum Firmicutes) is revealed in many studies, with subsequent recovery of these bacterial populations within next 2 months. This time dynamics is in accordance with reported data on depletion of certain anaerobic gut bacteria, e.g., Ruminococcus, Faecalibacterium spp., Roseburia, Blautia post-transplant, being associated with severe complications in HCT patients. These results are in accordance with severe posttransplant dysbiosis at different mucosal sites post-HCT, as shown elsewhere by routine bacteriology techniques. The metabolism of bacteria with positive effect on GVHD includes both vitamin D and vitamin A. It was demonstrated that Ruminococcus abundance is dependent on vitamin A and D intake. Another bacteria genera Faecalibacterium prausnitzii, which is also reported to produce butyrate and reduce GVHD is also dependent on abundance of vitamin A. The big phylum Firmicutes are also dependant on vitamin D and their abundance is reported to be associated with lower incidence of immune complications and suppression of antibiotic-resistant strains. To summarize the idea of the study is based on modulation of gut microbiota, which in term may result in lower incidence of GVHD and toxic complications of HCT.
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Biphenotypic Acute Leukemia, Lymphoblastic Lymphoma, Chronic Myeloid Leukemia, Myelodysplastic Syndromes
- Being tested
- Vitamin A, Vitamin D3
- Keywords
- allogeneic hematopoietic transplantation, vitamin A, vitamin D
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Leukemia, Biphenotypic, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myelodysplastic Syndromes, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin ADrug
300 000 IU single dose orally
Vitamin D3Drug
100 000 IU single dose orally
| Study group | Role | What they receive |
|---|---|---|
| Vitamin supplementation | Experimental | vitamin A 300 000 IU and vitamin D 100 000 IU on days -14 to -8 before transplantation Receives: Drug: Vitamin A; Drug: Vitamin D3 |
| Routine care | No intervention | Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 125 days
Secondary outcomes (9)
Incidence of HSCT-associated adverse events
Toxicity assessment is based on presence of NCI CTC AE 5.0 event grades 3-5. Veno-occlusive disease incidence and severity assessment is based on EBMT criteria 2020. Transplant-associated microangiopathy incidence assessment is based on Harmonization criteria. All toxicity measurements will be aggregated as severity scores
Measured: 125 days
Infectious complications
Incidence of infections, including analysis of severe bacterial, fungal and viral infections incidence
Measured: 125 days
Overall survival
Kaplan-Meier estimate of either relapse, primary or secondary graft failure or death from all causes
Measured: 2 years
Event-free survival
Kaplan-Meier estimate of either relapse, primary or secondary graft failure or death from all causes
Measured: 2 years
Overall cumulative incidence of acute GVHD grade II-IV
Cumulative incidence of patients with acute GVHD II-IV grade, competing risk is death, relapse and primary graft failure
Measured: 125 days
Incidence of moderate and severe chronic GVHD
Cumulative incidence of patients with moderate and severe chronic GVHD according to NIH 2015 criteria, competing risk is death, relapse and primary graft failure
Measured: 2 years
Non-relapse mortality analysis
Cumulative incidence of patients with mortality without hematological relapse of malignancy
Measured: 2 years
GVHD-relapse-free survival analysis
Kaplan-Meier estimate of death, acute GVHD grade III-IV, severe chronic GVHD or relapse
Measured: 2 years
Cumulative incidence of primary and secondary graft failure
Cumulative primary and secondary graft failure, competing risk is death and relapse
Measured: 125 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start15 May 2024
- Primary completionMay 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan S Moiseev, St. Petersburg State Pavlov Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508099
- Sponsor's protocol ID
- 18/24-n
- Acronym
- VitaStem
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Written study proposal to Pavlov University Ethical Committee.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Vitamin A and D Prophylaxis Before Allogeneic Related and Unrelated Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06508099
- Acronym / sponsor ID
- VitaStem / 18/24-n
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Biphenotypic Acute Leukemia, Lymphoblastic Lymphoma, Chronic Myeloid Leukemia, Myelodysplastic Syndromes
- Keywords
- allogeneic hematopoietic transplantation, vitamin A, vitamin D
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Currently there is an emerging evidence of gut microbiota role in major complications of HCT, including GVHD, oral mucositis, infectious complications due to multi-drug resistant bacteria in the gut. Early exhaustion of most intestinal bacterial phyla after HSCT is documented in many studies. This effect of intensive anti-infectious therapy is well known. Most authors explain the disruption of intestinal microbiota by massive antibiotic treatment in order to prevent infectious complications due to immune deficiency following HCT. Early decrease in anaerobic bacteria (phylum Firmicutes) is revealed in many studies, with subsequent recovery of these bacterial populations within next 2 months. This time dynamics is in accordance with reported data on depletion of certain anaerobic gut bacteria, e.g., Ruminococcus, Faecalibacterium spp., Roseburia, Blautia post-transplant, being associated with severe complications in HCT patients. These results are in accordance with severe posttransplant dysbiosis at different mucosal sites post-HCT, as shown elsewhere by routine bacteriology techniques. The metabolism of bacteria with positive effect on GVHD includes both vitamin D and vitamin A. It was demonstrated that Ruminococcus abundance is dependent on vitamin A and D intake. Another bacteria genera Faecalibacterium prausnitzii, which is also reported to produce butyrate and reduce GVHD is also dependent on abundance of vitamin A. The big phylum Firmicutes are also dependant on vitamin D and their abundance is reported to be associated with lower incidence of immune complications and suppression of antibiotic-resistant strains. To summarize the idea of the study is based on modulation of gut microbiota, which in term may result in lower incidence of GVHD and toxic complications of HCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin supplementation | Experimental | Drug: Vitamin A, Drug: Vitamin D3vitamin A 300 000 IU and vitamin D 100 000 IU on days -14 to -8 before transplantation |
| Routine care | No intervention | –Routine care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis: acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, chronic myeloproliferative disease, chronic myeloid leukemia, lymphoblastic lymphoma, myeloma
- Standard disease risk: less than 5% clonal blasts in the bone marrow and the absence of blast forms in the peripheral blood at the time of inclusion in the study or at least partial response for lymphoproliferative neoplasms.
- 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
Key exclusion criteria (11 listed)
- - 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;
- Uncontrolled bacterial or fungal infection at the time of inclusion, despite adequate antibacterial or antifungal therapy (CRP>70 mg/l at the time of inclusion).
- Karnofsky index less than 70%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin A300 000 IU single dose orally | Drug | Vitamin supplementation |
| Vitamin D3100 000 IU single dose orally | Drug | Vitamin supplementation |
Primary outcome
Cumulative incidence of gastrointestinal acute GVHD
Time frame: 125 days
Cumulative incidence of patients with acute GVHD II-IV grade, competing risk is death, relapse and primary graft failure
9 secondary outcomes
Incidence of HSCT-associated adverse events
Time frame: 125 days
Infectious complications
Time frame: 125 days
Overall survival
Time frame: 2 years
Event-free survival
Time frame: 2 years
Overall cumulative incidence of acute GVHD grade II-IV
Time frame: 125 days
Incidence of moderate and severe chronic GVHD
Time frame: 2 years
Non-relapse mortality analysis
Time frame: 2 years
GVHD-relapse-free survival analysis
Time frame: 2 years
Cumulative incidence of primary and secondary graft failure
Time frame: 125 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: Yes. Written study proposal to Pavlov University Ethical Committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin A and Vitamin D3 in people with Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IVAN SERGEEVICH MOISEEV (+78123386265, moisiv@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of gastrointestinal acute GVHD (time frame: 125 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.