Status:
UNKNOWN
An Open Label Study of Multiple Doses of Cannabidiol in the Prevention of Acute Graft-Versus-Host Disease (GVHD)
Lead Sponsor:
Kalytera Therapeutics Israel, Ltd.
Conditions:
Prevention aGVHD
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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) af...
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)...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
June 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2022
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03840512
Start Date
June 12 2018
End Date
December 15 2022
Last Update
September 1 2021
Active Locations (5)
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1
St Vincent's Hospital Sydney - The Kinghorn Cancer Centre
Sydney, Australia, 2010
2
Rambam Health Care - Bone Marrow Transplantation Unit
Haifa, Israel, 3109601
3
Hadassah Medical Center - Bone Marrow Transplantation Department, Cancer Immunotherapy and Immunobiology Research Center
Jerusalem, Israel, 91120
4
Davidof Cancer Center, Beilinson hospital, Rabin medical center
Petah Tikva, Israel, 49100