Acute-graft-versus-host DiseasePhase 2NCT02392780
Cannabidiol for the Treatment of Severe (Grades III/IV) Acute Graft-versus-host Disease
A Phase 2 study testing Cannabidiol, Methylprednisolone and Calcineurin inhibitor in people with Acute-graft-versus-host Disease, run by moshe yeshurun at 1 site in Israel.
Trial summary
Graft-versus-host-disease (GVHD) is a major obstacle to successful allogeneic hematopoietic cell transplantation (alloHCT). Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa possesses potent anti-inflammatory and immunosuppressive properties. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute-graft-versus-host Disease
- What is being tested?
- Cannabidiol, Methylprednisolone and Calcineurin inhibitor
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2015to 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
- Patients 18 years or older
- After allogeneic transplantation
- Grade III or IV acute GVHD
- No psychiatric contra-indication
- Informed consent
Who cannot join
- History of psychosis
- Asthma
- Known allergy to cannabis constituents
Trial locations and contacts
1 site in 1 country.
Israel1 site
Davidof Cancer Center, Beilinson hospital, Rabin medical center
Petah Tikva
Moshe Yeshurun, MD, 972-50-4065543, moshey@clalit.org.il
Liat Shargian, MD, 972-54-2394930, LIATSHR@clalit.org.il
About this study
Graft-versus-host-disease (GVHD) is a major obstacle to successful allogeneic hematopoietic cell transplantation (alloHCT). Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa possesses potent anti-inflammatory and immunosuppressive properties. In a recent phase 2 study, CBD has been shown to be safe and reduced significantly the incidence of acute GVHD compared to control patients with a hazard ratio of 0.3. Based on these results the investigators propose a phase 2 study to explore the efficacy of oral CBD in the treatment of severe (grades III/IV) acute GVHD, a pathology with a dismal prognosis.
- Conditions
- Acute-graft-versus-host Disease
- Being tested
- Cannabidiol, Methylprednisolone, Calcineurin inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Oral cannabidiol at a dose of 150 mg BID up to 90 days.
IV methylprednisolone 2 mg/kg/day
Calcineurin inhibitorDrug
cyclosporine with dose adjusted based on drug trough levels (200-400 ng/ml) or tacrolimus with dose adjusted on drug trough levels (5-15 ng/ml)
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol | Experimental | Not described Receives: Drug: Cannabidiol; Drug: Methylprednisolone; Drug: Calcineurin inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with complete remission of acute GVHD
Measured: 90 days
Secondary outcomes (4)
Proportion of patients with partial remission of acute GVHD
Measured: 90 days
Proportion of patients with chronic GVHD
Measured: 12 months
Proportion of patients able to discontinue immunosuppression
Measured: 12 months
Transplant related mortality
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 posted19 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute-graft-versus-host DiseaseStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- moshe yeshurun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, moshe yeshurun, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392780
- Sponsor's protocol ID
- 0009-15-RMC
- Status last verified
- Mar 2015
- First submitted
- 9 Mar 2015
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabidiol for the Treatment of Severe (Grades III/IV) Acute Graft-versus-host Disease
- ClinicalTrials.gov ID
- NCT02392780
- Acronym / sponsor ID
- 0009-15-RMC
- Conditions
- Acute-graft-versus-host Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- moshe yeshurunUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2018 (estimated)
- First posted
- 19 Mar 2015 (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.
Graft-versus-host-disease (GVHD) is a major obstacle to successful allogeneic hematopoietic cell transplantation (alloHCT). Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa possesses potent anti-inflammatory and immunosuppressive properties. In a recent phase 2 study, CBD has been shown to be safe and reduced significantly the incidence of acute GVHD compared to control patients with a hazard ratio of 0.3. Based on these results the investigators propose a phase 2 study to explore the efficacy of oral CBD in the treatment of severe (grades III/IV) acute GVHD, a pathology with a dismal prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol | Experimental | Drug: Cannabidiol, Drug: Methylprednisolone, Drug: Calcineurin inhibitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients 18 years or older
- After allogeneic transplantation
- Grade III or IV acute GVHD
- No psychiatric contra-indication
- Informed consent
Key exclusion criteria (3 listed)
- History of psychosis
- Asthma
- Known allergy to cannabis constituents
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 |
|---|---|---|
| CannabidiolOral cannabidiol at a dose of 150 mg BID up to 90 days. | Drug | Cannabidiol |
| MethylprednisoloneIV methylprednisolone 2 mg/kg/day | Drug | Cannabidiol |
| Calcineurin inhibitorcyclosporine with dose adjusted based on drug trough levels (200-400 ng/ml) or tacrolimus with dose adjusted on drug trough levels (5-15 ng/ml) | Drug | Cannabidiol |
Primary outcome
Proportion of patients with complete remission of acute GVHD
Time frame: 90 days
4 secondary outcomes
Proportion of patients with partial remission of acute GVHD
Time frame: 90 days
Proportion of patients with chronic GVHD
Time frame: 12 months
Proportion of patients able to discontinue immunosuppression
Time frame: 12 months
Transplant related mortality
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
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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.
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 Cannabidiol, Methylprednisolone and Calcineurin inhibitor in people with Acute-graft-versus-host Disease, run by moshe yeshurun 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 3 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 19 Mar 2015. 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 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 Moshe Yeshurun, MD (972-50-4065543, moshey@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with complete remission of acute GVHD (time frame: 90 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 19 Mar 2015.