An Open Label Study of Multiple Doses of Cannabidiol in the Prevention of Acute Graft-Versus-Host Disease (GVHD)

NCT ID: NCT03840512

Last Updated: 2021-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-12
• Study Completion Date: 2022-12-15

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) 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.

Conditions

Prevention aGVHD

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Oral CBD 75 BID

Group Type: EXPERIMENTAL

CBD

Intervention Type: DRUG

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.

Oral CBD 150 BID

Group Type: EXPERIMENTAL

CBD

Intervention Type: DRUG

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.

Oral CBD 300 BID

Group Type: EXPERIMENTAL

CBD

Intervention Type: DRUG

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.

Interventions

CBD

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Any malignant hematological disease in CR or Myelodysplastic Syndrome (MDS)

2. Age ≥ 18 years

3. Karnofsky Score (KS) ≥ 60%

4. HSCT-Comorbidity Index (HSCT-CI) score ≤ 3

5. No major organ dysfunction

6. Myeloablative or reduced intensity conditioning regimen

7. Matched (7/8 or 8/8) unrelated donor

8. Peripheral blood stem cell graft

9. 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.

10. Male subjects with partners of childbearing potential must agree to use adequate contraception (barrier method or abstinence) during the study.

11. Subject's written informed consent

Exclusion Criteria

1. Malignant hematological disease other than MDS, not in CR

2. Myelofibrosis

3. Allogeneic transplantation from a matched or mismatched sibling donor

4. Cord blood transplantation

5. Positive serology for HIV

6. Serious psychiatric or psychological disorders

7. Any uncontrolled infection at time of registration

8. Active consumption of illicit drugs (such as: Crack cocaine, Heroin, Methamphetamines, Cocaine, Bath Salts, Amphetamines, Methadone, Benzodiazepine, Ecstasy)

9. Use of Cannabis and/or its derivatives fourteen days prior to HSCT and for the duration of study participation

10. Uncontrolled hepatitis B or active hepatitis C infection.

11. QTc>450ms per Fridericia's correction and Impaired cardiac function or clinically significant cardiac diseases

12. Inadequate renal function defined as measured creatinine clearance > 2.0 mg/dl

13. Liver enzymes: ALT and AST > 3x upper limit of normal

14. Pregnancy or breastfeeding ((positive serum β-HCG 7 days before first dose)

15. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kalytera Therapeutics Israel, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Davidof Cancer Center, Beilinson hospital, Rabin medical center

Petah Tikva, , Israel

Tel-Aviv Sourasky Medical Center - Bone Marrow Transplantation Unit

Tel Aviv, , Israel

St Vincent's Hospital Sydney - The Kinghorn Cancer Centre

Sydney, , Australia

Rambam Health Care - Bone Marrow Transplantation Unit

Haifa, , Israel

Hadassah Medical Center - Bone Marrow Transplantation Department, Cancer Immunotherapy and Immunobiology Research Center

Jerusalem, , Israel

Countries

Australia; Israel

Other Identifiers

KAL05

Identifier Type: -

Identifier Source: org_study_id