| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| GVHD | Drug: Bortezomib Drug: Cyclophosphamide | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 47 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Study of High-Dose Post-Transplant Cyclophosphamide and Bortezomib (CyBor) for the Prevention of Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) |
| Actual Study Start Date : | June 20, 2019 |
| Estimated Primary Completion Date : | November 2022 |
| Estimated Study Completion Date : | November 2022 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Cyclophosphamide and Bortezomib |
Drug: Bortezomib
1.3 mg/m2 IV 6 hours after graft infusion and 72 hours thereafter.
Drug: Cyclophosphamide 50 mg/kg IV over 2 hours on Day +3 and +4
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Ankeeta Joshi | 2122634431 | Ankeeta.Joshi@nyulangone.org |
| United States, New York | |
| New York University School of Medicine | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Ankeeta Joshi 212-263-4431 Ankeeta.Joshi@nyulangone.org | |
| Principal Investigator: Ahmad Al-Homsi, MD | |
| Principal Investigator: | Ahmad Al-Homsi, MD | New York Langone Medical Center |
| Tracking Information | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 8, 2019 | ||||||||||
| First Posted Date ICMJE | May 10, 2019 | ||||||||||
| Last Update Posted Date | April 22, 2021 | ||||||||||
| Actual Study Start Date ICMJE | June 20, 2019 | ||||||||||
| Estimated Primary Completion Date | November 2022 (Final data collection date for primary outcome measure) | ||||||||||
| Current Primary Outcome Measures ICMJE |
|
||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||
| Change History | |||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||
| Descriptive Information | |||||||||||
| Brief Title ICMJE | High-Dose Post-Transplant Cyclophosphamide and Bortezomib (CyBor) for the Prevention of Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) | ||||||||||
| Official Title ICMJE | A Phase II Study of High-Dose Post-Transplant Cyclophosphamide and Bortezomib (CyBor) for the Prevention of Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) | ||||||||||
| Brief Summary | This is a single arm open label phase II clinical trial. Adult patients with hematological malignancies undergoing allogeneic HSCT from matched-related or unrelated donor are eligible for the study if they meet the standard criteria defined in the investigator's institutional standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Patients will receive reduced-intensity or myeloablative conditioning regimen of fludarabine, busulfan, and rabbit anti-thymocyte globulin (rATG). Patients will receive PTCyBor as GvHD prophylaxis. | ||||||||||
| Detailed Description | Not Provided | ||||||||||
| Study Type ICMJE | Interventional | ||||||||||
| Study Phase ICMJE | Phase 2 | ||||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | GVHD | ||||||||||
| Intervention ICMJE |
|
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| Study Arms ICMJE | Experimental: Cyclophosphamide and Bortezomib
Interventions:
|
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| Publications * | Not Provided | ||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||
| Estimated Enrollment ICMJE |
47 | ||||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||||
| Estimated Study Completion Date ICMJE | November 2022 | ||||||||||
| Estimated Primary Completion Date | November 2022 (Final data collection date for primary outcome measure) | ||||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||||
| Removed Location Countries | |||||||||||
| Administrative Information | |||||||||||
| NCT Number ICMJE | NCT03945591 | ||||||||||
| Other Study ID Numbers ICMJE | 18-01185 | ||||||||||
| Has Data Monitoring Committee | No | ||||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | NYU Langone Health | ||||||||||
| Study Sponsor ICMJE | NYU Langone Health | ||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||
| Investigators ICMJE |
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| PRS Account | NYU Langone Health | ||||||||||
| Verification Date | April 2021 | ||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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