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Carfilzomib for the Prevention of Graft Versus Host Disease

This study is currently recruiting participants.
Verified December 2015 by Sheba Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01991301
First Posted: November 25, 2013
Last Update Posted: December 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sheba Medical Center
  Purpose
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.

Condition Intervention Phase
Graft-versus-host Disease Drug: carfilzumib Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Carfilzomib -a Novel Proteasome Inhibitor- for the Prevention of Acute Graft Versus Host Disease

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • incidence of acute graft-versus host disease [ Time Frame: 3 months ]
    We will evaluate the incidence of acute GVHD, grading and organ involvementBY STANDARD INTERNATIONAL CRITERIA.


Secondary Outcome Measures:
  • incidence of chronic graft-versus-host disease [ Time Frame: 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.

  • survival rate [ Time Frame: 2 years ]
    We will evaluate overall and disease-free survival after stem cell transplantation


Estimated Enrollment: 30
Study Start Date: November 2014
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: carfilzumib
Carfilzomib at a dose of 20mg/m2 I.V. will be administrated at day 1, 2 post infusion of the stem cell (SC) graft to the first 10 patients. If no > grade II toxicity* the next 10 patients will receive Carfilzomib (27 mg/m2) at day 1,2 and 8, 9, 15 and 16. If no > grade II toxicity* the next 10 patients will receive 2-3 cycles of Carfilzomib (27 mg/m2) administered at day 1,2 8,9,15 and 16 post SC graft infusion.
Drug: carfilzumib
carfilzumib will be added to the standard regimen of drugs for prevention of graft-versus-host disease.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991301


Contacts
Contact: Arnon Nagler, MD 972 3 530 5830 a.nagler@sheba.health.gov.il
Contact: Avichai Shimoni, MD 972 3 530 5830 ashimoni@sheba.health.gov.il

Locations
Israel
Chaim Sheba Medical Center Recruiting
Tel-Hashomer, Israel, 52621
Contact: Arnon Nagler, MD    972 3 530 5830    a.nagler@sheba.health.gov.il   
Contact: Avichai Shimoni, MD    972 3 530 5830    ashimoni@sheba.health.gov.il   
Principal Investigator: Arnon Nagler, MD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Arnon Nagler, MD Chaim Sheba Medical Center
  More Information

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01991301     History of Changes
Other Study ID Numbers: SHEBA-12-9997-AN-CTIL
First Submitted: November 18, 2013
First Posted: November 25, 2013
Last Update Posted: December 2, 2015
Last Verified: December 2015

Keywords provided by Sheba Medical Center:
graft-versus-host disease
stem cell transplantation
matched unrelated donors
proteosmoe inhibitor
carfilzumib

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Proteasome Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action