Myelodysplastic SyndromePhase 2/3NCT02042482
The Effect of Combination Ultra Q10 and L-carnitine on the Course of Myelodysplastic Syndrome
A Phase 2/3 study testing Coenzyme Q10U, L-carnitine in people with Myelodysplastic Syndrome, run by Kaplan Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is determine whether combination Q10 , L-carnitine and multivitamin and mineral complex is effective in treatment of patients with low and intermidiate1-2 risk Myelodysplastic syndrome Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Myelodysplastic Syndrome
- What is being tested?
- Coenzyme Q10U, L-carnitine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- May 2013to May 2016
- Phase
- Phase 2/3
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient willing and able complies with the protocol requirements. Patient given voluntary written informed consent before performance of any study-related procedure that is not part of standard medical care; with the understanding that the consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Patient is older than 18 years at the time of signing the informed consent. Patients older than 80 years will sign informed consent after psycho-geriatric evaluation.
- Patient diagnosed with Myelodysplastic syndrome, Low risk and intermediate-1risk according to international prognostic scoring system with hemoglobin level less than 11g/l or platelets less than 100000/ mcl or absolute neutrophils count less than 1000/mcl. With or without fatigue syndrome.
- INT-2 and high risk patients may be included into this trial when they are not eligible for other treatment except Best Supportive Cure or failure to other conventional treatment approach.
- Bone marrow aspiration examination including cytogenetics performed up to 12 months before inclusion and absence clinic-laboratory evidence of progressive disease in last month Patient has a life-expectancy > 3 months
Who cannot join
- Any serious medical conditions, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds the experimental ability to interpret data from the study.
- Pregnant or lactating females. Prior history of malignancies, other than MDS, unless the subject has been free of the disease for ≥ 3 years. Exceptions include the following: Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histological finding of prostate cancer (TNM stage of T1a or T1b).
- Bone marrow blast count >30%. Patient has known active infectious hepatitis B or C, or HIV infection Administration of investigational drugs in the last 3 months. High risk MDS patients and INT-2 patients who are candidates for cytoreductive or epigenetics treatment.
- Any psychological, sociological condutions likely to affect compliance with the study follow-up schedule.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Kaplan Medical Center
Rehovot, 76100
Kalman Filanovsky, MD, 97289441747, kalmanph@clalit.org.il
About this study
Official title: The Effect of the Nutritional Supplements: Ultra Q10 and L-carnitine on the Clinical Course of Myelodysplastic Syndrome
The purpose of this study is determine whether combination Q10 , L-carnitine and multivitamin and mineral complex is effective in treatment of patients with low and intermidiate1-2 risk Myelodysplastic syndrome
Read the detailed description
The primary objectives of this study are to assess response (as measured by increase in blood counts, cytogenetic/molecular changes in the bone marrow, improved endurance) to the supplements treatment.
The secondary objectives are to determine:
Quality of life assessment(FACT: QOL Questionnaire) Cancer fatigue reduction. Physiological functioning assessment Rate and depth transfusion reduction Duration of response. Time to progression. Overall survival. Estimated cytokine profile and another immunological and biochemical parameters of mitochondrial function before and after six months of treatment.
- Conditions
- Myelodysplastic Syndrome
- Being tested
- Coenzyme Q10U, L-carnitine
- Keywords
- Ultra coenzyme Q10, L-carnitine
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10U, L-carnitineDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Coenzyme Q10U, L-carnitine | Experimental | Patients receive combination of coenzyme Q10U 180 milligram and L-carnitine 2000 milligram Receives: Dietary Supplement: Coenzyme Q10U, L-carnitine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Hemoglobin, Platlets,White blood counts
Measured: 12 weeks,24 weeks
Secondary outcomes (4)
Overall response rate
Measured: 24 weeks
Progression free survival
Measured: 24 weeks,52 weeks
Duration of response
Measured: 24 weeks 52 weeks
Quality of life.
Measured: 12 weeks 24 weeks 36weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startMay 2013
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromeStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Weizmann Institute of Science
- Responsible party
- Principal investigator, Dr Kalman Filanovsky, Kaplan Medical Center
- Investigators
- Kalman Kalman, MD, Principal investigator, Kaplan Medical Center, Institute of hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042482
- Sponsor's protocol ID
- KMC01-35-12
- Status last verified
- Jan 2014
- First submitted
- 15 Jan 2014
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Nutritional Supplements: Ultra Q10 and L-carnitine on the Clinical Course of Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT02042482
- Acronym / sponsor ID
- KMC01-35-12
- Conditions
- Myelodysplastic Syndrome
- Keywords
- Ultra coenzyme Q10, L-carnitine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Collaborators
- Weizmann Institute of Science
- Study start
- May 2013
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 22 Jan 2014 (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.
The purpose of this study is determine whether combination Q10 , L-carnitine and multivitamin and mineral complex is effective in treatment of patients with low and intermidiate1-2 risk Myelodysplastic syndrome
Detailed description
The primary objectives of this study are to assess response (as measured by increase in blood counts, cytogenetic/molecular changes in the bone marrow, improved endurance) to the supplements treatment.
The secondary objectives are to determine:
Quality of life assessment(FACT: QOL Questionnaire) Cancer fatigue reduction. Physiological functioning assessment Rate and depth transfusion reduction Duration of response. Time to progression. Overall survival. Estimated cytokine profile and another immunological and biochemical parameters of mitochondrial function before and after six months of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coenzyme Q10U, L-carnitine | Experimental | Dietary Supplement: Coenzyme Q10U, L-carnitinePatients receive combination of coenzyme Q10U 180 milligram and L-carnitine 2000 milligram |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient willing and able complies with the protocol requirements. Patient given voluntary written informed consent before performance of any study-related procedure that is not part of standard medical care; with the understanding that the consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Patient is older than 18 years at the time of signing the informed consent. Patients older than 80 years will sign informed consent after psycho-geriatric evaluation.
- Patient diagnosed with Myelodysplastic syndrome, Low risk and intermediate-1risk according to international prognostic scoring system with hemoglobin level less than 11g/l or platelets less than 100000/ mcl or absolute neutrophils count less than 1000/mcl. With or without fatigue syndrome.
- INT-2 and high risk patients may be included into this trial when they are not eligible for other treatment except Best Supportive Cure or failure to other conventional treatment approach.
- Bone marrow aspiration examination including cytogenetics performed up to 12 months before inclusion and absence clinic-laboratory evidence of progressive disease in last month Patient has a life-expectancy > 3 months
Key exclusion criteria (4 listed)
- Any serious medical conditions, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds the experimental ability to interpret data from the study.
- Pregnant or lactating females. Prior history of malignancies, other than MDS, unless the subject has been free of the disease for ≥ 3 years. Exceptions include the following: Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histological finding of prostate cancer (TNM stage of T1a or T1b).
- Bone marrow blast count >30%. Patient has known active infectious hepatitis B or C, or HIV infection Administration of investigational drugs in the last 3 months. High risk MDS patients and INT-2 patients who are candidates for cytoreductive or epigenetics treatment.
- Any psychological, sociological condutions likely to affect compliance with the study follow-up schedule.
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 |
|---|---|---|
| Coenzyme Q10U, L-carnitine | Dietary supplement | Coenzyme Q10U, L-carnitine |
Primary outcome
Change from baseline Hemoglobin, Platlets,White blood counts
Time frame: 12 weeks,24 weeks
4 secondary outcomes
Overall response rate
Time frame: 24 weeks
Progression free survival
Time frame: 24 weeks,52 weeks
Duration of response
Time frame: 24 weeks 52 weeks
Quality of life.
Time frame: 12 weeks 24 weeks 36weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
Related trials for Myelodysplastic Syndrome
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 1/2
Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS
High Grade Myelodysplastic Syndromes
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
Kalman Kalman, MD principal investigator
Kaplan Medical Center, Institute of hematology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Coenzyme Q10U, L-carnitine in people with Myelodysplastic Syndrome, run by Kaplan Medical Center at 1 site in Israel.
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 4 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: status not confirmed, as of the sponsor's last update on 22 Jan 2014. 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 Israel. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kalman Filanovsky,, MD (972-89441747, kalmanph@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Hemoglobin, Platlets,White blood counts (time frame: 12 weeks,24 weeks). 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 22 Jan 2014.