Graft vs Host DiseasePhase 2NCT02478424
Extended Use of Cannabidiol for the Prevention of Graft-versus-host-disease
A Phase 2 study testing Cannabidiol, cyclosporine and Methotrexate in people with Graft vs Host Disease, run by Rabin Medical Center.
Trial summary
Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa possesses potent anti-inflammatory and immunosuppressive properties. In a recent prospective phase II study (NCT01385124) 48 consecutive adult patients undergoing allogeneic hematopoietic cell transplantation were given CBD 300 mg/day starting 7 days… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft vs Host Disease
- What is being tested?
- Cannabidiol, cyclosporine and Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jun 2017
- 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
- Acute leukemia in complete remission
- Myeloablative conditioning
- Matched or one antigen or allele mismatched sibling or unrelated donor
Who cannot join
- History of psychosis
- Bronchial asthma
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Extended Use of Cannabidiol for the Prevention of Graft-versus-host Disease After Allogeneic Hematopoietic Cell Transplantation
Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa possesses potent anti-inflammatory and immunosuppressive properties. In a recent prospective phase II study (NCT01385124) 48 consecutive adult patients undergoing allogeneic hematopoietic cell transplantation were given CBD 300 mg/day starting 7 days before transplantation until day 30, on top of standard GVHD prophylaxis consisting of cyclosporine and a short course of methotrexate. There were no grade 3-4 toxicities attributed to CBD. None of the patients developed acute GVHD while consuming CBD. With a median follow-up of 16 months, the cumulative incidence rates of grade 2-4 and grade 3-4 acute GVHD by day 100 were 12.1% and 5%, respectively. Compared to 101 historical control subjects given standard GVHD prophylaxis, the hazard ratio of developing grade 2-4 acute GVHD among subjects treated with CBD plus standard GVHD prophylaxis was 0.3 (p=0.0002). Among patients surviving more than 100 days, the cumulative incidence of moderate-to-severe chronic GVHD at 12 and 18 months were 20% and 33%, respectively.
The aim of this study is to explore the safety and efficacy of extended use of CBD until day 100 in the prevention of acute and chronic GVHD.
- Conditions
- Graft vs Host Disease
- Being tested
- Cannabidiol, cyclosporine, Methotrexate
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called CBD
Patients will receive standard GVHD prophylaxis consisting of cyclosporine A twice daily starting on day -1 with target trough levels of 200-400 ng/mL and a short course of methotrexate (15 mg/ m2 on day 1 and 10 mg/ m2 on days days 3 and 6). Patients transplanted from unrelated donors will receive ATG Fresenius at a low dose of 5 mg/kg on days -3 to -1.
Patients will be given oral CBD 150 mg BID starting 7 days before transplantation until day 100.
cyclosporineDrug
MethotrexateDrug
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol arm | Experimental | Patients undergoing an allogeneic hematopoietic cell transplantation will be given standard GVHD prophylaxis comprising cyclosporine and a short course of methotrexate plus CBD 150 mg BID starting 7 days before transplantation until day 100. Receives: Drug: Cannabidiol; Drug: cyclosporine; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade 2-4 and grade 3-4 acute GVHD by day 100
Measured: 100 days
grade 3-4 adverse effects attributed to CBD consumption
Measured: 180 days
Incidence of overall chronic GVHD and moderate to severe chronic GVHD by 12 months
Measured: 12 months
Incidence of late onset acute GVHD
Measured: 12 months
Secondary outcomes (5)
Non relapse mortality
Measured: 12 months
Relapse rate
Measured: 12 months
Overall survival
Measured: 12 months
Adherence to study protocol
Percentage of doses actually taken as reported by patients
Measured: Until day 100
Disease free and immunosuppression free survival by 12 months
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 posted23 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft vs 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478424
- Sponsor's protocol ID
- RMC-0208-14
- Status last verified
- Jun 2015
- First submitted
- 15 Jun 2015
- Last updated
- 23 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Use of Cannabidiol for the Prevention of Graft-versus-host Disease After Allogeneic Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT02478424
- Acronym / sponsor ID
- RMC-0208-14
- Conditions
- Graft vs Host Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 23 Jun 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.
Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa possesses potent anti-inflammatory and immunosuppressive properties. In a recent prospective phase II study (NCT01385124) 48 consecutive adult patients undergoing allogeneic hematopoietic cell transplantation were given CBD 300 mg/day starting 7 days before transplantation until day 30, on top of standard GVHD prophylaxis consisting of cyclosporine and a short course of methotrexate. There were no grade 3-4 toxicities attributed to CBD. None of the patients developed acute GVHD while consuming CBD. With a median follow-up of 16 months, the cumulative incidence rates of grade 2-4 and grade 3-4 acute GVHD by day 100 were 12.1% and 5%, respectively. Compared to 101 historical control subjects given standard GVHD prophylaxis, the hazard ratio of developing grade 2-4 acute GVHD among subjects treated with CBD plus standard GVHD prophylaxis was 0.3 (p=0.0002). Among patients surviving more than 100 days, the cumulative incidence of moderate-to-severe chronic GVHD at 12 and 18 months were 20% and 33%, respectively.
The aim of this study is to explore the safety and efficacy of extended use of CBD until day 100 in the prevention of acute and chronic GVHD.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol arm | Experimental | Drug: Cannabidiol, Drug: cyclosporine, Drug: MethotrexatePatients undergoing an allogeneic hematopoietic cell transplantation will be given standard GVHD prophylaxis comprising cyclosporine and a short course of methotrexate plus CBD 150 mg BID starting 7 days before transplantation until day 100. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute leukemia in complete remission
- Myeloablative conditioning
- Matched or one antigen or allele mismatched sibling or unrelated donor
Key exclusion criteria (2 listed)
- History of psychosis
- Bronchial asthma
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 |
|---|---|---|
| CannabidiolAlso: CBDPatients will receive standard GVHD prophylaxis consisting of cyclosporine A twice daily starting on day -1 with target trough levels of 200-400 ng/mL and a short course of methotrexate (15 mg/ m2 on day 1 and 10 mg/ m2 on days days 3 and 6). Patients transplanted from unrelated donors will receive ATG Fresenius at a low dose of 5 mg/kg on days -3 to -1. Patients will be given oral CBD 150 mg BID starting 7 days before transplantation until day 100. | Drug | Cannabidiol arm |
| cyclosporine | Drug | Cannabidiol arm |
| Methotrexate | Drug | Cannabidiol arm |
Primary outcome
Incidence of grade 2-4 and grade 3-4 acute GVHD by day 100
Time frame: 100 days
grade 3-4 adverse effects attributed to CBD consumption
Time frame: 180 days
Incidence of overall chronic GVHD and moderate to severe chronic GVHD by 12 months
Time frame: 12 months
Incidence of late onset acute GVHD
Time frame: 12 months
5 secondary outcomes
Non relapse mortality
Time frame: 12 months
Relapse rate
Time frame: 12 months
Overall survival
Time frame: 12 months
Adherence to study protocol
Time frame: Until day 100
Disease free and immunosuppression free survival by 12 months
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 23 Jun 2015.
Related trials for Graft vs Host Disease
Active, not recruitingPhase 2
De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis
Graft-versus-host Disease
RecruitingEarly Phase 1
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Hematologic Malignancy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
RecruitingPhase 1/2
The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation
Peripheral Blood Stem Cell Transplantation, Hematopoietic Stem Cell Transplantation
RecruitingPhase 1/2
Phase I/II Study of Pacritinib, A JAK2/IRAK1/CSF1R Inhibitor, in Refractory Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Graft vs Host Disease
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol, cyclosporine and Methotrexate in people with Graft vs Host Disease, run by Rabin Medical Center.
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 2 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 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of grade 2-4 and grade 3-4 acute GVHD by day 100 (time frame: 100 days). The study lists 4 primary outcomes in all. 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 23 Jun 2015.