Carfilzomib for the Prevention of Graft Versus Host Disease

Graft-versus-host Disease Clinical Trial

Official title:

The Safety and Efficacy of Carfilzomib -a Novel Proteasome Inhibitor- for the Prevention of Acute Graft Versus Host Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01991301
• Other study ID #: SHEBA-12-9997-AN-CTIL
• Status: Recruiting
• Phase: Phase 1
• First received: November 18, 2013
• Last updated: December 1, 2015
• Start date: November 2014
• Est. completion date: November 2017

Study information

• Verified date: December 2015
• Source: Sheba Medical Center
• Contact: Arnon Nagler, MD
• Phone: 972 3 530 5830
• Email: a.nagler[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the safety and efficacy of Carfilzumib, which is a novel biological agent used in the treatment of multiple myeloma in preventing graft-versus-host disease, after stem cells transplantation from unrelated donors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patients with MDS/AML

2. 18 years or older and willing and able to comply with the protocol requirements.

3. LVEF = 40%. 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation. Multigated Acquisition Scan (MUGA) is acceptable if ECHO is not available.

4. Patients undergoing 8-10/10 HLA matched unrelated and unmanipulated PBSC transplantation

5. Patients conditioned with reduced intensity or reduced toxicity conditioning i.e. Fludarabine combine with Treosulfan or 2-4 days of I.V Busulfan.

6. Patients must sign written informed consent.

7. Adequate birth control in fertile patients.

Exclusion Criteria:

1. Patients undergoing other type of transplantation or with other type of basic disease other than AML or MDS.

2. Patients with respiratory failure (DLCO < 30%).

3. Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention.

4. Patients with > grade II liver renal toxicity.

5. Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate

6. Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit

7. Creatinine > 2.0 mg/dl

8. ECOG-Performance status > 2

9. Uncontrolled infection

10. Pregnancy or lactation

11. CNS disease involvement

12. Pleural effusion or ascites > 1 liter.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft-versus-host Disease

Intervention

Drug:
• carfilzumib
carfilzumib will be added to the standard regimen of drugs for prevention of graft-versus-host disease.

Locations

Country	Name	City	State
Israel	Chaim Sheba Medical Center	Tel-Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of acute graft-versus host disease	We will evaluate the incidence of acute GVHD, grading and organ involvementBY STANDARD INTERNATIONAL CRITERIA.	3 months	Yes
Secondary	incidence of chronic graft-versus-host disease	We will evaluate the progression of acute graft-versus-host disease to chronic graft-versus-host disease and the grading and organ involvement.	1 year	Yes
Secondary	survival rate	We will evaluate overall and disease-free survival after stem cell transplantation	2 years	Yes