CML, Chronic PhasePhase 2ICT10NCT02949570
Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study
A Phase 2 study testing Inecalcitol in people with CML, Chronic Phase, run by Hybrigenics Corporation at 1 site in France.
Trial summary
To assess the efficacy of inecalcitol in combination with imatinib in CML patients with molecular residual disease on imatinib monotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CML, Chronic Phase
- What is being tested?
- Inecalcitol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Apr 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged of at least 18 years at the time of informed consent signature;
- Patients have signed written informed consent;
- ECOG performance status < 2;
- Patients with Philadelphia chromosome positive chronic phase CML and M BCR-ABL transcript positivity (e13a2 or e14a2);
- Treatment with imatinib for more than 2 years (a history of treatment with interferon is tolerated);
- Patient in complete cytogenetic response with BCR-ABL/ABL status between 0.1% International Scale (IS) and 0.01% IS and no BCR-ABL checkpoint in the last six months better than Molecular Response MR4 ( i.e. BCR-ABL ratio < 0.01% IS);
Show all 10Show fewer
- Women of child bearing potential have a negative pregnancy test prior to first dose and agree to practice effective contraception during the study;
- Fertile men agree to practice effective contraception during the study;
- Patients agree to comply with the study requirements and agree to come to the clinic for required study visits;
- Patients agree to follow medication restrictions during the study;
Who cannot join
- Expression of unusual BCR-ABL transcripts (other than e13a2 or e14a2);
- Pregnant or lactating women;
- Participating in another clinical trial with any investigative drug within 30 days prior to study enrolment(except for OPTIM imatinib);
- Treatment with interferon within the last 24 months;
- Imatinib dose modification within the last 3 months;
- Prior history of haematopoietic stem cell transplantation;
Show all 16Show fewer
- Impaired renal function with creatinine clearance < 30 ml/min/1.73m² according to the MDRD formula;
- Hypercalcemia (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;
- 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);
- Patients with a chronic condition which is not well controlled that, according to the investigator, would interfere with the completion of the study;
- Use of any other experimental drug, therapy or vitamin D supplementation within 30 days of first inecalcitol administration;
- Patients with a mental deficiency preventing proper understanding of trial protocol requirements;
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Côte de Nacre
Caen, 14033
Hyacinthe Johnson- Ansah, MD, +33-2-31-27-25-39, johnsonansah-a@chu-caen.fr
About this study
Official title: Phase 2 Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study
To assess the efficacy of inecalcitol in combination with imatinib in CML patients with molecular residual disease on imatinib monotherapy.
Read the detailed description
To determine:
- Duration of response
- Progression free survival
- Proportion of responders 2 years after discontinuation of inecalcitol
- Duration of response after discontinuation of inecalcitol and imatinib
- Bone remodelling effect
- Safety of inecalcitol in combination with imatinib
- Quality of Life
- Conditions
- CML, Chronic Phase
- Being tested
- Inecalcitol
- Medical subject headings
- Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InecalcitolDrug
Prospective open label, non-comparative, multicentre exploratory study. Divided in 2 parts Part1: Inecalcitol treatment will be added to imatinib for 12 months. Part 2: Follow-up after discontinuation of inecalcitol. Imatinib will be maintained for 2 years and then will be stopped for those still in MR4.5. These patients will then be followed for 2 additional years after discontinuation of imatinib.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: Inecalcitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the proportion of responders
Proportion of responder defined as patients achieving MR4.5 (i.e. detectable disease ≤ 0.0032 % BCR-ABLIS or undetectable disease with cDNA with ≥32,000 ABL1 transcripts) at any time within 12 months after the initiation of inecalcitol.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startFeb 2014
- Primary completionFeb 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CML, Chronic PhaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hybrigenics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Francois Dufour-Lamartinie, MD, Study director, Hybrigenics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949570
- Sponsor's protocol ID
- ICT10
- Other IDs
- 2014-004347-12, 2014
- Acronym
- ICT10
- Status last verified
- Oct 2016
- First submitted
- 27 Oct 2016
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study
- ClinicalTrials.gov ID
- NCT02949570
- Acronym / sponsor ID
- ICT10 / ICT10
- Conditions
- CML, Chronic Phase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Hybrigenics CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 31 Oct 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.
To assess the efficacy of inecalcitol in combination with imatinib in CML patients with molecular residual disease on imatinib monotherapy.
Detailed description
To determine:
- Duration of response
- Progression free survival
- Proportion of responders 2 years after discontinuation of inecalcitol
- Duration of response after discontinuation of inecalcitol and imatinib
- Bone remodelling effect
- Safety of inecalcitol in combination with imatinib
- Quality of Life
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Inecalcitol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men or women aged of at least 18 years at the time of informed consent signature;
- Patients have signed written informed consent;
- ECOG performance status < 2;
- Patients with Philadelphia chromosome positive chronic phase CML and M BCR-ABL transcript positivity (e13a2 or e14a2);
- Treatment with imatinib for more than 2 years (a history of treatment with interferon is tolerated);
Key exclusion criteria (16 listed)
- Expression of unusual BCR-ABL transcripts (other than e13a2 or e14a2);
- Pregnant or lactating women;
- Participating in another clinical trial with any investigative drug within 30 days prior to study enrolment(except for OPTIM imatinib);
- Treatment with interferon within the last 24 months;
- Imatinib dose modification within the last 3 months;
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 |
|---|---|---|
| InecalcitolProspective open label, non-comparative, multicentre exploratory study. Divided in 2 parts Part1: Inecalcitol treatment will be added to imatinib for 12 months. Part 2: Follow-up after discontinuation of inecalcitol. Imatinib will be maintained for 2 years and then will be stopped for those still in MR4.5. These patients will then be followed for 2 additional years after discontinuation of imatinib. | Drug | Treatment |
Primary outcome
Measure the proportion of responders
Time frame: 12 months
Proportion of responder defined as patients achieving MR4.5 (i.e. detectable disease ≤ 0.0032 % BCR-ABLIS or undetectable disease with cDNA with ≥32,000 ABL1 transcripts) at any time within 12 months after the initiation of inecalcitol.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for CML, Chronic Phase
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 2
Personalized NK Cell Therapy in CBT
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Biphenotypic Leukemia
RecruitingPhase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Malignancy, Hematologic, Neoplasms, Hematologic
Not yet recruitingPhase 1/2
Phase 1/2 FLAG-IDA, VEN and Asciminib in CML and Ph+ AML
Myeloid Leukemia
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 study director
Hybrigenics
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 Inecalcitol in people with CML, Chronic Phase, run by Hybrigenics Corporation at 1 site in France.
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 10 inclusion and 16 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 31 Oct 2016. 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 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. 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 Jean-Francois Dufour-Lamartinie, MD (+33-158103805, jfdufour@hybrigenics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the proportion of responders (time frame: 12 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 31 Oct 2016.