Chronic Lymphoid LeukemiaPhase 3D-HEMNCT01518959
The Effect of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases
A Phase 3 study testing Cholecalciferol and oleum neutralicum in people with Chronic Lymphoid Leukemia, run by Semmelweis University at 1 site in Hungary.
Trial summary
Recent data have shown that the inadequate vitamin D status plays a role in the manifestation of the haematologic tumors and serum vitamin D level has a prognostic role also as it determines the tumor mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphoid Leukemia
- What is being tested?
- Cholecalciferol and oleum neutralicum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteHungary
- Study dates
- Jan 2012to Jan 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- at least 18 years old male or female
- chronic lymphoid leukaemia, any Rai stage
- 25-OH-Vitamin-D3 level between 10 and 30 ng/mL
Who cannot join
- serum calcium > 2,60 mmol/l
- 24 hour calcium urine excretion > 0,1 mmol/kg/day
- serum phosphate > 1,45 mmol/l
- eGFR < 30 ml/min/1,73m2
- nephrolithiasis
- receiving parenteral vitamin-D3 in past 6 months
- activated vitamin-D3 treatment
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University - 1st Departement of Internal Medicine
Budapest, 1083
About this study
Official title: Phase III, Controlled, Double-blind, Randomized Study of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases
Recent data have shown that the inadequate vitamin D status plays a role in the manifestation of the haematologic tumors and serum vitamin D level has a prognostic role also as it determines the tumor mortality. But data have not proved a causal relationship between the inadequate vitamin D status and the unfavourable outcomes so far. It is also still unknown, whether the normalization of vitamin D status in patient with vitamin D inadequacy is able to improve the prognosis and survival.
In this study the investigators examine the role of the adequate vitamin D substitution in the improvement of the outcomes of haematologic disorders.
- Conditions
- Chronic Lymphoid Leukemia
- Being tested
- Cholecalciferol, oleum neutralicum
- Medical subject headings
- Leukemia, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
180.000 IU monthly
oleum neutralicumDrug
Placebo comparator, 9 ml monthly
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | no treatment Receives: Drug: oleum neutralicum |
| Cholecalcipherol | Active comparator | Treatment with 180 000 IU cholecalcipherol monthly Receives: Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: up to 5 years
Secondary outcomes (2)
Time to treatment needed
Measured: up to 5 years
Blood lymphocyte count
Measured: monthly, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: Insufficient recruitment rate; technical issues with sample storage
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphoid LeukemiaStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Istvan Takacs, Semmelweis University
- Investigators
- Istvan Takacs, MD, PhD, Principal investigator, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518959
- Sponsor's protocol ID
- D-HEM
- Acronym
- D-HEM
- Status last verified
- Jul 2020
- First submitted
- 6 Jan 2012
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Controlled, Double-blind, Randomized Study of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases
- ClinicalTrials.gov ID
- NCT01518959
- Acronym / sponsor ID
- D-HEM / D-HEM
- Conditions
- Chronic Lymphoid Leukemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment rate; technical issues with sample storage
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 26 Jan 2012 (estimated)
- 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.
Recent data have shown that the inadequate vitamin D status plays a role in the manifestation of the haematologic tumors and serum vitamin D level has a prognostic role also as it determines the tumor mortality. But data have not proved a causal relationship between the inadequate vitamin D status and the unfavourable outcomes so far. It is also still unknown, whether the normalization of vitamin D status in patient with vitamin D inadequacy is able to improve the prognosis and survival.
In this study the investigators examine the role of the adequate vitamin D substitution in the improvement of the outcomes of haematologic disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: oleum neutralicumno treatment |
| Cholecalcipherol | Active comparator | Drug: CholecalciferolTreatment with 180 000 IU cholecalcipherol monthly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 18 years old male or female
- chronic lymphoid leukaemia, any Rai stage
- 25-OH-Vitamin-D3 level between 10 and 30 ng/mL
Key exclusion criteria (7 listed)
- serum calcium > 2,60 mmol/l
- 24 hour calcium urine excretion > 0,1 mmol/kg/day
- serum phosphate > 1,45 mmol/l
- eGFR < 30 ml/min/1,73m2
- nephrolithiasis
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 |
|---|---|---|
| Cholecalciferol180.000 IU monthly | Drug | Cholecalcipherol |
| oleum neutralicumPlacebo comparator, 9 ml monthly | Drug | Placebo |
Primary outcome
Overall survival
Time frame: up to 5 years
2 secondary outcomes
Time to treatment needed
Time frame: up to 5 years
Blood lymphocyte count
Time frame: monthly, up to 5 years
Results and safety
The study was stopped early (reason given: Insufficient recruitment rate; technical issues with sample storage). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
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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. This study is not recruiting at the moment.
Istvan Takacs, MD, PhD principal investigator
Semmelweis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cholecalciferol and oleum neutralicum in people with Chronic Lymphoid Leukemia, run by Semmelweis University at 1 site in Hungary.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 16 Jul 2020. 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 Hungary. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruitment rate; technical issues with sample storage). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: up to 5 years). 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 16 Jul 2020.