Carfilzomib for the Prevention of Graft Versus Host Disease

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01991301

Enrollment

Registered

2013-11-25

Start date

2014-11-30

Completion date

2017-11-30

Last updated

2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft-versus-host Disease

Keywords

graft-versus-host disease, stem cell transplantation, matched unrelated donors, proteosmoe inhibitor, carfilzumib

Brief 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.

Interventions

DRUGcarfilzumib

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
incidence of acute graft-versus host disease	3 months	We will evaluate the incidence of acute GVHD, grading and organ involvementBY STANDARD INTERNATIONAL CRITERIA.

Secondary

Measure	Time frame	Description
survival rate	2 years	We will evaluate overall and disease-free survival after stem cell transplantation
incidence of chronic graft-versus-host disease	1 year	We will evaluate the progression of acute graft-versus-host disease to chronic graft-versus-host disease and the grading and organ involvement.

Countries

Israel

Contacts

Primary ContactArnon Nagler, MD

a.nagler@sheba.health.gov.il972 3 530 5830

Backup ContactAvichai Shimoni, MD

ashimoni@sheba.health.gov.il972 3 530 5830

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026