Carfilzomib for the Prevention of Graft Versus Host Disease
NCT ID: NCT01991301
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2014-11-30
2017-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
carfilzumib
carfilzumib will be added to the standard regimen of drugs for prevention of graft-versus-host disease.
Interventions
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carfilzumib
carfilzumib will be added to the standard regimen of drugs for prevention of graft-versus-host disease.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Arnon Nagler, MD
Role: PRINCIPAL_INVESTIGATOR
Chaim Sheba Medical Center
Locations
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Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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Shimoni A, Shem-Tov N, Yerushalmi R, Danylesko I, Nagler A. Carfilzomib combined with cyclosporine and methotrexate for the prevention of graft-versus-host disease after allogeneic stem-cell transplantation from unrelated donors. Bone Marrow Transplant. 2021 Feb;56(2):451-456. doi: 10.1038/s41409-020-01044-5. Epub 2020 Sep 2.
Other Identifiers
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SHEBA-12-9997-AN-CTIL
Identifier Type: -
Identifier Source: org_study_id