Acute Myelogenous LeukemiaPhase 2NCT02802267
Efficacy Study of Inecalcitol With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy
A Phase 2 study testing Inecalcitol in people with Acute Myelogenous Leukemia, run by Hybrigenics Corporation at 8 sites in 2 countries.
Trial summary
Evaluate the effect of the addition of inecalcitol to decitabine treatment on overall survival in previously untreated AML patients aged 65 years or more who are randomly assigned to receive decitabine with or without inecalcitol. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Myelogenous Leukemia
- What is being tested?
- Inecalcitol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jun 2016to Dec 2019
- Phase
- Phase 2
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients aged 65 to < 75 years with at least one non severe comorbidity ie disease or syndrome with mild to moderate clinical or diagnostic observations or lab abnormalities which could increase the risk of toxicity and/or early death of intensive chemotherapy in the opinion of the investigator and are not contra-indicated for non-intensive chemotherapy.
- or ≥ 75 years with or without any comorbidity at the time of the informed consent signature;
- Newly diagnosed, untreated de novo or secondary AML according to WHO classification;
Who cannot join
- Prior or current treatment with chemotherapy for any myeloid disorder (excluding hydroxyurea) or radiotherapy for extramedullary involvement within 2 weeks of randomization;
- Prior treatment with decitabine, azacitidine, or cytarabine;
- Prior malignancies for 5 years with exception of basal cell, squamous cell carcinoma of the skin, or carcinoma " in situ " of the cervix or breast;
- Chronic myelogenous or acute promyelocytic leukaemia;
- Known CNS involvement;
- Patient eligible to bone marrow or stem cell transplant;
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- WBC ≥ 30.000/mm3;
- Impaired renal function with Creatinine clearance < 30 mL/min/1.73m² according to the MDRD formula;
- Serum bilirubin ≥ 2.5 x ULN and/or AST and/or ALT ≥ 2.5 x ULN (upper limit of normal value);
- Calcemia ≥ 2.65 mmol/L (106 mg/L) at screening assessment (corrected with albuminemia);
- History of diseases known to be associated with calcium disorders: ongoing hyperparathyroidism, sarcoidosis….;
- Presence or history of symptomatic kidney stones in the last 5 years;
- Hypersensitivity to any of the excipients of decitabine (Potassium dihydrogen phosphate (E340) ; Sodium hydroxide (E524) ; Hydrochloric acid (for pH adjustment) or to the excipient of inecalcitol tablets (lactose);
- Current use of drugs known to influence serum calcium (such as thiazide diuretics, teriparatide, calcitonin and multivitamin supplements containing > 400 IU of vitamin D or calcium);
- Current use of digitalis;
- Current use of drugs which could influence bioavailability of inecalcitol (such as magnesium-containing antacids, bile-resin binders);
- Use of any other experimental drug or therapy or vitamin D supplementation within 4 weeks of randomization;
- Known HIV;
- Patients who are eligible for intensive induction therapy with curative intent;
- Refractory congestive heart failure;
- Active infection resistant to anti-infective therapy;
- Documented pulmonary disease with DLCO ≤ 65% or FEV1≤ 65%, or dyspnea at rest or requiring oxygen, or any pleural neoplasm or uncontrolled lung neoplasm;
- Liver cirrhosis Child B or C or acute viral hepatitis;
- Current mental illness requiring psychiatric hospitalization, institutionalization or intensive outpatient management, or current cognitive status that produces dependence (as confirmed by the specialist) not controlled by the caregiver;
- Uncontrolled neoplasia;
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites, 7 recruiting
- Recruiting
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, 87106
Kaylee Deutsch, MHA, CCRP, kdeutsch@nmcca.org
April Encee, RN, OCN, aencee@salud.unm.edu
- Recruiting
Georgia Cancer Center-Augusta University
Augusta, Georgia, 30912
Jeremy M Pantin, M.D.
Christine Sanchez, csanchez@augusta.edu
- Recruiting
Duke Cancer Institute, Duke Univ Medical Center
Durham, North Carolina, 27710
David Rizzieri, M.D.
Rachel Stowe, rachel.stowe@duke.edu
- Recruiting
University of Texas; M D Anderson Cancer Center
Houston, Texas, 77030
Jorge Cortes, M.D.
Jane A Autry, JAAutry@mdanderson.org
- Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Khin Win, MBBS, CCRC, khin.win@usoncology.com
Tiffany Gordon, tiffany.gordon@usoncology.com
- Recruiting
Scripps Health
San Diego, California, 92103
Marin Xavier, M.D.
Boyka S Petrov, Petrov.Boyka@scrippshealth.org
- Not yet recruiting
ProHealth Care Inc
Waukesha, Wisconsin, 53188
Dawn Minikel, dawn.minikel@phci.org
Amelia Crouse, amelia.crouse@phci.org
France1 site, 1 recruiting
- Recruiting
Necker Hospital- APHP
Paris, 75015
Olivier Hermine, MD, PhD
About this study
Official title: Efficacy Study of Inecalcitol in Combination With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy
Evaluate the effect of the addition of inecalcitol to decitabine treatment on overall survival in previously untreated AML patients aged 65 years or more who are randomly assigned to receive decitabine with or without inecalcitol.
- Conditions
- Acute Myelogenous Leukemia
- Being tested
- Inecalcitol, Placebo Oral Tablet
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InecalcitolDrug
vitamin D receptor agonist
Placebo Oral TabletDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| inecalcitol | Experimental | Two tablets of Inecalcitol 2mg each (total 4mg) taken orally every other day. Receives: Drug: Inecalcitol |
| placebo | Placebo comparator | Two tablets of placebo 2mg each (total 4mg) taken orally every other day Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myelogenous 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hybrigenics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Francois Dufour-Lamartinie, MD, Principal investigator, Hybrigenics Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802267
- Sponsor's protocol ID
- ICT8
- Status last verified
- Jun 2017
- First submitted
- 13 Jun 2016
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of Inecalcitol in Combination With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy
- ClinicalTrials.gov ID
- NCT02802267
- Acronym / sponsor ID
- ICT8
- Conditions
- Acute Myelogenous Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Hybrigenics CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 16 Jun 2016 (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.
Evaluate the effect of the addition of inecalcitol to decitabine treatment on overall survival in previously untreated AML patients aged 65 years or more who are randomly assigned to receive decitabine with or without inecalcitol.
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 |
|---|---|---|
| inecalcitol | Experimental | Drug: InecalcitolTwo tablets of Inecalcitol 2mg each (total 4mg) taken orally every other day. |
| placebo | Placebo comparator | Drug: Placebo Oral TabletTwo tablets of placebo 2mg each (total 4mg) taken orally every other day |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients aged 65 to < 75 years with at least one non severe comorbidity ie disease or syndrome with mild to moderate clinical or diagnostic observations or lab abnormalities which could increase the risk of toxicity and/or early death of intensive chemotherapy in the opinion of the investigator and are not contra-indicated for non-intensive chemotherapy.
- or ≥ 75 years with or without any comorbidity at the time of the informed consent signature;
- Newly diagnosed, untreated de novo or secondary AML according to WHO classification;
Key exclusion criteria (25 listed)
- Prior or current treatment with chemotherapy for any myeloid disorder (excluding hydroxyurea) or radiotherapy for extramedullary involvement within 2 weeks of randomization;
- Prior treatment with decitabine, azacitidine, or cytarabine;
- Prior malignancies for 5 years with exception of basal cell, squamous cell carcinoma of the skin, or carcinoma " in situ " of the cervix or breast;
- Chronic myelogenous or acute promyelocytic leukaemia;
- Known CNS involvement;
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 |
|---|---|---|
| Inecalcitolvitamin D receptor agonist | Drug | inecalcitol |
| Placebo Oral Tabletplacebo | Drug | placebo |
Primary outcome
overall survival
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Jean-Francois Dufour-Lamartinie, MD principal investigator
Hybrigenics Corporation
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inecalcitol in people with Acute Myelogenous Leukemia, run by Hybrigenics Corporation at 8 sites in 2 countries.
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 25 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, France. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shankar Srinivasan, PhD (+1-2246221775, ssrinivasan@hybrigenics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 24 months). 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 2 Jul 2017.