Prevention aGVHDPhase 2NCT03840512
An Open Label Study of Multiple Doses of Cannabidiol in the Prevention of Acute Graft-Versus-Host Disease (GVHD)
A Phase 2 study testing CBD in people with Prevention aGVHD, run by Kalytera Therapeutics Israel, Ltd. at 5 sites in 2 countries.
Trial summary
A prospective, open-label, phase 2a study, to evaluate the pharmacokinetic (PK) profile, safety, and efficacy of multiple doses of Cannabidiol (CBD) in participants Graft-Versus-Host Disease (GVHD) after allogeneic hematopoietic stem cell transplantation (HSCT) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prevention aGVHD
- What is being tested?
- CBD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 12 Jun 2018to 15 Dec 2022
- 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
- Any malignant hematological disease in CR or Myelodysplastic Syndrome (MDS)
- Age ≥ 18 years
- Karnofsky Score (KS) ≥ 60%
- HSCT-Comorbidity Index (HSCT-CI) score ≤ 3
- No major organ dysfunction
- Myeloablative or reduced intensity conditioning regimen
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- Matched (7/8 or 8/8) unrelated donor
- Peripheral blood stem cell graft
- Female subjects of childbearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for the follow-up time period. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.
- Male subjects with partners of childbearing potential must agree to use adequate contraception (barrier method or abstinence) during the study.
- Subject's written informed consent
Who cannot join
- Malignant hematological disease other than MDS, not in CR
- Myelofibrosis
- Allogeneic transplantation from a matched or mismatched sibling donor
- Cord blood transplantation
- Positive serology for HIV
- Serious psychiatric or psychological disorders
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- Any uncontrolled infection at time of registration
- Active consumption of illicit drugs (such as: Crack cocaine, Heroin, Methamphetamines, Cocaine, Bath Salts, Amphetamines, Methadone, Benzodiazepine, Ecstasy)
- Use of Cannabis and/or its derivatives fourteen days prior to HSCT and for the duration of study participation
- Uncontrolled hepatitis B or active hepatitis C infection.
- QTc>450ms per Fridericia's correction and Impaired cardiac function or clinically significant cardiac diseases
- Inadequate renal function defined as measured creatinine clearance > 2.0 mg/dl
- Liver enzymes: ALT and AST > 3x upper limit of normal
- Pregnancy or breastfeeding ((positive serum β-HCG 7 days before first dose)
- Treatment with another investigational drug, biological agent, or device within 30 days of first dose, or investigational cell therapy within 6 months of first dose
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Israel4 sites
Rambam Health Care - Bone Marrow Transplantation Unit
Haifa, 3109601
Hadassah Medical Center - Bone Marrow Transplantation Department, Cancer Immunotherapy and Immunobiology Research Center
Jerusalem, 91120
Davidof Cancer Center, Beilinson hospital, Rabin medical center
Petah Tikva, 49100
Tel-Aviv Sourasky Medical Center - Bone Marrow Transplantation Unit
Tel Aviv
Australia1 site
St Vincent's Hospital Sydney - The Kinghorn Cancer Centre
Sydney, 2010
About this study
Official title: A Phase 2a, Open-label, Multicenter, Study to Evaluate the Pharmacokinetic (PK), Safety and Efficacy of Multiple Doses of Cannabidiol for the Prevention of aGVHD After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
A prospective, open-label, phase 2a study, to evaluate the pharmacokinetic (PK) profile, safety, and efficacy of multiple doses of Cannabidiol (CBD) in participants Graft-Versus-Host Disease (GVHD) after allogeneic hematopoietic stem cell transplantation (HSCT)
Read the detailed description
The study contains 3 cohorts of 12 participants each: All participants will be orally administered for 105 days with CBD at doses of 75, 150 or 300 mg (PO) BID for the prevention of acute GVHD (aGVHD) following allogeneic HSCT.
In addition to the study drug, all participants will receive standard aGVHD prophylaxis consisting of a calcineurin inhibitor (cyclosporine or tacrolimus) and a short course of methotrexate (MTX). After completion of 105 treatment days, the participant will be followed-up until day 180.
- Conditions
- Prevention aGVHD
- Being tested
- CBD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBDDrug
CBD + Standard aGVHD prophylaxis calcineurin inhibitor (cyclosporine or tacrolimus) + methotrexate (MTX).
Subjects transplanted from unrelated donors or from mismatched siblings will also receive anti-T cell globulin.
| Study group | Role | What they receive |
|---|---|---|
| Oral CBD 75 BID | Experimental | Not described Receives: Drug: CBD |
| Oral CBD 150 BID | Experimental | Not described Receives: Drug: CBD |
| Oral CBD 300 BID | Experimental | Not described Receives: Drug: CBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs) and serious adverse events (SAEs) Reporting
All AEs will be recorded, whether considered minor or serious, drug-related or not
Measured: Up to day 180
Cumulative incidence of aGVHD at day 100 post-transplant
Cumulative Incidence of Grade B-D aGvHD
Measured: First 100 days after transplant
Pharmacokinetic parameters of Cannabidiol (CBD) - Cmax
Pharmacokinetic (PK) profile - Cmax - Maximum Plasma Concentration
Measured: Blood samples will be obtained on Day 7 before HSCT and Day 7 post HSCT. Sampling times: immediately after CBD dosing and at 15, 30, 45, 60, 120, 180, and 240 minutes, and 8, 12 and 24 hours after dosing of CBD
Pharmacokinetic parameters of Cannabidiol (CBD) - Tmax
Pharmacokinetic (PK) profile - Tmax - time to reach maximum plasma concentration
Measured: Blood samples will be obtained on Day 7 before HSCT and Day 7 post HSCT. Sampling times: immediately after CBD dosing and at 15, 30, 45, 60, 120, 180, and 240 minutes, and 8, 12 and 24 hours after dosing of CBD
Pharmacokinetic parameters of Cannabidiol (CBD) - Tlag
Pharmacokinetic (PK) profile - Tlag - Absorption lag-time defined as the time of the first concentration ≥ Limit of Quantitation (LOQ)
Measured: Blood samples will be obtained on Day 7 before HSCT and Day 7 post HSCT. Sampling times: immediately after CBD dosing and at 15, 30, 45, 60, 120, 180, and 240 minutes, and 8, 12 and 24 hours after dosing of CBD
Pharmacokinetic parameters of Cannabidiol (CBD) - AUC0-t
Pharmacokinetic (PK) profile - AUC0-t - area under the plasma concentration-time curve (AUC0-t) up to the last quantifiable concentration (LOQ) from time of administration (t=0) up to the selected
Measured: Blood samples will be obtained on Day 7 before HSCT and Day 7 post HSCT. Sampling times: immediately after CBD dosing and at 15, 30, 45, 60, 120, 180, and 240 minutes, and 8, 12 and 24 hours after dosing of CBD
Pharmacokinetic parameters of Cannabidiol (CBD) - λz
Pharmacokinetic (PK) profile: λz - Elimination rate constant determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve
Measured: Blood samples will be obtained on Day 7 before HSCT and Day 7 post HSCT. Sampling times: immediately after CBD dosing and at 15, 30, 45, 60, 120, 180, and 240 minutes, and 8, 12 and 24 hours after dosing of CBD
Pharmacokinetic parameters of Cannabidiol (CBD) - T1/2
Pharmacokinetic (PK) profile: T1/2 - Terminal elimination half-life
Measured: Blood samples will be obtained on Day 7 before HSCT and Day 7 post HSCT. Sampling times: immediately after CBD dosing and at 15, 30, 45, 60, 120, 180, and 240 minutes, and 8, 12 and 24 hours after dosing of CBD
Pharmacokinetic parameters of Cannabidiol (CBD) - AUC0-∞
Pharmacokinetic (PK) profile: AUC0-∞ - area under the plasma concentration-time curve extrapolated to infinity
Measured: Blood samples will be obtained on Day 7 before HSCT and Day 7 post HSCT. Sampling times: immediately after CBD dosing and at 15, 30, 45, 60, 120, 180, and 240 minutes, and 8, 12 and 24 hours after dosing of CBD
Cumulative incidence of aGVHD at day 180 post-transplant
Cumulative Incidence of Grade 2-4 aGvHD
Measured: Day 180 post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start12 Jun 2018
- Primary completion15 Nov 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention aGVHDStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kalytera Therapeutics Israel, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840512
- Sponsor's protocol ID
- KAL05
- Status last verified
- Aug 2021
- First submitted
- 10 Feb 2019
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Open-label, Multicenter, Study to Evaluate the Pharmacokinetic (PK), Safety and Efficacy of Multiple Doses of Cannabidiol for the Prevention of aGVHD After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
- ClinicalTrials.gov ID
- NCT03840512
- Acronym / sponsor ID
- KAL05
- Conditions
- Prevention aGVHD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Kalytera Therapeutics Israel, Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 15 Nov 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 15 Feb 2019 (actual)
- 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.
A prospective, open-label, phase 2a study, to evaluate the pharmacokinetic (PK) profile, safety, and efficacy of multiple doses of Cannabidiol (CBD) in participants Graft-Versus-Host Disease (GVHD) after allogeneic hematopoietic stem cell transplantation (HSCT)
Detailed description
The study contains 3 cohorts of 12 participants each: All participants will be orally administered for 105 days with CBD at doses of 75, 150 or 300 mg (PO) BID for the prevention of acute GVHD (aGVHD) following allogeneic HSCT.
In addition to the study drug, all participants will receive standard aGVHD prophylaxis consisting of a calcineurin inhibitor (cyclosporine or tacrolimus) and a short course of methotrexate (MTX). After completion of 105 treatment days, the participant will be followed-up until day 180.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral CBD 75 BID | Experimental | Drug: CBD |
| Oral CBD 150 BID | Experimental | Drug: CBD |
| Oral CBD 300 BID | Experimental | Drug: CBD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Any malignant hematological disease in CR or Myelodysplastic Syndrome (MDS)
- Age ≥ 18 years
- Karnofsky Score (KS) ≥ 60%
- HSCT-Comorbidity Index (HSCT-CI) score ≤ 3
- No major organ dysfunction
Key exclusion criteria (15 listed)
- Malignant hematological disease other than MDS, not in CR
- Myelofibrosis
- Allogeneic transplantation from a matched or mismatched sibling donor
- Cord blood transplantation
- Positive serology for HIV
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 |
|---|---|---|
| CBDCBD + Standard aGVHD prophylaxis calcineurin inhibitor (cyclosporine or tacrolimus) + methotrexate (MTX). Subjects transplanted from unrelated donors or from mismatched siblings will also receive anti-T cell globulin. | Drug | Oral CBD 150 BID, Oral CBD 300 BID, Oral CBD 75 BID |
Primary outcome
Adverse Events (AEs) and serious adverse events (SAEs) Reporting
Time frame: Up to day 180
All AEs will be recorded, whether considered minor or serious, drug-related or not
Cumulative incidence of aGVHD at day 100 post-transplant
Time frame: First 100 days after transplant
Cumulative Incidence of Grade B-D aGvHD
Pharmacokinetic parameters of Cannabidiol (CBD) - Cmax
Time frame: Blood samples will be obtained on Day 7 before HSCT and Day 7 post HSCT. Sampling times: immediately after CBD dosing and at 15, 30, 45, 60, 120, 180, and 240 minutes, and 8, 12 and 24 hours after dosing of CBD
Pharmacokinetic (PK) profile - Cmax - Maximum Plasma Concentration
Pharmacokinetic parameters of Cannabidiol (CBD) - Tmax
Time frame: Blood samples will be obtained on Day 7 before HSCT and Day 7 post HSCT. Sampling times: immediately after CBD dosing and at 15, 30, 45, 60, 120, 180, and 240 minutes, and 8, 12 and 24 hours after dosing of CBD
Pharmacokinetic (PK) profile - Tmax - time to reach maximum plasma concentration
Pharmacokinetic parameters of Cannabidiol (CBD) - Tlag
Time frame: Blood samples will be obtained on Day 7 before HSCT and Day 7 post HSCT. Sampling times: immediately after CBD dosing and at 15, 30, 45, 60, 120, 180, and 240 minutes, and 8, 12 and 24 hours after dosing of CBD
Pharmacokinetic (PK) profile - Tlag - Absorption lag-time defined as the time of the first concentration ≥ Limit of Quantitation (LOQ)
Pharmacokinetic parameters of Cannabidiol (CBD) - AUC0-t
Time frame: Blood samples will be obtained on Day 7 before HSCT and Day 7 post HSCT. Sampling times: immediately after CBD dosing and at 15, 30, 45, 60, 120, 180, and 240 minutes, and 8, 12 and 24 hours after dosing of CBD
Pharmacokinetic (PK) profile - AUC0-t - area under the plasma concentration-time curve (AUC0-t) up to the last quantifiable concentration (LOQ) from time of administration (t=0) up to the selected
Pharmacokinetic parameters of Cannabidiol (CBD) - λz
Time frame: Blood samples will be obtained on Day 7 before HSCT and Day 7 post HSCT. Sampling times: immediately after CBD dosing and at 15, 30, 45, 60, 120, 180, and 240 minutes, and 8, 12 and 24 hours after dosing of CBD
Pharmacokinetic (PK) profile: λz - Elimination rate constant determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve
Pharmacokinetic parameters of Cannabidiol (CBD) - T1/2
Time frame: Blood samples will be obtained on Day 7 before HSCT and Day 7 post HSCT. Sampling times: immediately after CBD dosing and at 15, 30, 45, 60, 120, 180, and 240 minutes, and 8, 12 and 24 hours after dosing of CBD
Pharmacokinetic (PK) profile: T1/2 - Terminal elimination half-life
Pharmacokinetic parameters of Cannabidiol (CBD) - AUC0-∞
Time frame: Blood samples will be obtained on Day 7 before HSCT and Day 7 post HSCT. Sampling times: immediately after CBD dosing and at 15, 30, 45, 60, 120, 180, and 240 minutes, and 8, 12 and 24 hours after dosing of CBD
Pharmacokinetic (PK) profile: AUC0-∞ - area under the plasma concentration-time curve extrapolated to infinity
Cumulative incidence of aGVHD at day 180 post-transplant
Time frame: Day 180 post-transplant
Cumulative Incidence of Grade 2-4 aGvHD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 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 CBD in people with Prevention aGVHD, run by Kalytera Therapeutics Israel, Ltd. at 5 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 11 inclusion and 15 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 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Israel, Australia. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) and serious adverse events (SAEs) Reporting (time frame: Up to day 180). The study lists 10 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 1 Sep 2021.