Cannabidiol for the Treatment of Severe (Grades III/IV) A... | NCT02392780

Studies
Cannabidiol for the Treatment of Severe (Grades III/IV) Acute Graft-versus-host Disease

NCT02392780

Sponsor

moshe yeshurun

Status

Unknown status

Last Update Posted

Mar 19, 2015Estimated

Enrollment

10Estimated

Phase

Phase 2

Conditions

Acute-graft-versus-host Disease

Interventions

Cannabidiol
Methylprednisolone
Calcineurin inhibitor

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Apr 2018Estimated

Completion Date

Not provided

First Submitted Date

Mar 9, 2015

First Submission Date that Met QC Criteria

Mar 18, 2015

First Posted Date

Mar 19, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2015

Last Update Posted Date

Mar 19, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cannabidiol	Experimental		Drug: Cannabidiol Drug: Methylprednisolone Drug: Calcineurin inhibitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cannabidiol	Drug	Oral cannabidiol at a dose of 150 mg BID up to 90 days.	Cannabidiol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients with complete remission of acute GVHD		90 days

Secondary Outcomes

Measure	Description	Time Frame
Proportion of patients with partial remission of acute GVHD		90 days
Proportion of patients with chronic GVHD		12 months
Proportion of patients able to discontinue immunosuppression

Other Outcomes

Measure	Description	Time Frame
Subpopulations of peripheral blood cells and cytokine levels	T4, T8, Foxp3 T regulatory cells, TNFα, INFγ, IL-1β, IL-6, IL-17, IL-4, IL-5, IL-10 and IL-13	12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients 18 years or older
After allogeneic transplantation
Grade III or IV acute GVHD
No psychiatric contra-indication
Informed consent

Exclusion Criteria:

History of psychosis
Asthma
Known allergy to cannabis constituents

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Moshe Yeshurun, MD	Contact	972-50-4065543		moshey@clalit.org.il
Liat Shargian, MD	Contact	972-54-2394930		LIATSHR@clalit.org.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Davidof Cancer Center, Beilinson hospital, Rabin medical center		Petah Tikva			Israel

Intervention Browse Module

MeSH Terms

ID	Term
D002185	Cannabidiol
D008775	Methylprednisolone
D065095	Calcineurin Inhibitors

Ancestor Terms

ID	Term
D002186	Cannabinoids
D013729	Terpenes
D006838	Hydrocarbons
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided