Condition or disease | Intervention/treatment | Phase |
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Acquired Hemophilia A | Drug: Bortezomib Drug: Rituximab | Phase 2 |
This is a prospective, single-arm, open-label clinical trial to evaluate the efficacy and safety the regimen of Bortezomib with rituximab as first-line treatment to eradicate anti-factor VIII antibodies in newly diagnosed acquired hemophilia A.
All of enrolled patients in this study will be injected Bortezomib plus rituximab. This study will be performed for about 2 years and approximately 22 patients will be enrolled in our insititution.
After obtaining the written informed consent from the patients, the information of demographic and medical history will be collected and laboratory tests will be performed.
Patients who meet the inclusion/exclusion criteria will be received the regimens: Bortezomib (1.3mg/m2 d1,4,8,11) with rituximab (375mg/m2 for one dose). The information of adverse events will be collected. In case that the evaluation of treatment response might be performed in regular clinical practice, those data will also be collected as well.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 22 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label Phase II Study to Determine the Efficacy and Safety of Rituximab and Bortezomib in Patients With Newly Diagnosed Acquired Hemophilia A |
Actual Study Start Date : | October 10, 2018 |
Estimated Primary Completion Date : | October 15, 2019 |
Estimated Study Completion Date : | April 15, 2020 |
Arm | Intervention/treatment |
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Experimental: Bortezomib +Rituximab
Bortezomib +Rituximab
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Drug: Bortezomib
Bortezomib intravenously 1.3mg/m2 d1,4,8,11 for 4 doses
Drug: Rituximab rituximab intravenously 500 mg for one dose
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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: Huacong Cai | 01069158271 | caihc@pumch.cn | |
Contact: Tienan Zhu | 01069158271 | zhutn@pumch.cn |
China, Beijing | |
Peking Union Medical College Hospital | Recruiting |
Beijing, Beijing, China, 100730 | |
Contact: Huacong Cai 01069158271 caihc@pumch.cn | |
Contact: Tienan Zhu, MD 01069158271 zhutn@pumch.cn | |
Principal Investigator: Tienan Zhu, MD |
Principal Investigator: | Tienan Zhu | Peking Union Medical College Hospital |
Tracking Information | |||||
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First Submitted Date ICMJE | October 4, 2018 | ||||
First Posted Date ICMJE | October 9, 2018 | ||||
Last Update Posted Date | November 23, 2018 | ||||
Actual Study Start Date ICMJE | October 10, 2018 | ||||
Estimated Primary Completion Date | October 15, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
The time to attain first complete remission (CR) [ Time Frame: Last day of the treatment regimen (up to 3 months) ] Complete remission defined as titer FVIII inhibitor lower than 0.6 Bethesda unit, factor VIII level> 50% and no bleeding events without bypass treatments for 24 hours
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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 | Study to Evaluate Rituximab and Bortezomib in Patients With Newly Diagnosed Acquired Hemophilia A | ||||
Official Title ICMJE | An Open-label Phase II Study to Determine the Efficacy and Safety of Rituximab and Bortezomib in Patients With Newly Diagnosed Acquired Hemophilia A | ||||
Brief Summary | The purpose of this prospective study is to determine the efficacy and safety of Rituximab plus Bortezomib in patients with newly diagnosed acquired hemophilia A. | ||||
Detailed Description |
This is a prospective, single-arm, open-label clinical trial to evaluate the efficacy and safety the regimen of Bortezomib with rituximab as first-line treatment to eradicate anti-factor VIII antibodies in newly diagnosed acquired hemophilia A. All of enrolled patients in this study will be injected Bortezomib plus rituximab. This study will be performed for about 2 years and approximately 22 patients will be enrolled in our insititution. After obtaining the written informed consent from the patients, the information of demographic and medical history will be collected and laboratory tests will be performed. Patients who meet the inclusion/exclusion criteria will be received the regimens: Bortezomib (1.3mg/m2 d1,4,8,11) with rituximab (375mg/m2 for one dose). The information of adverse events will be collected. In case that the evaluation of treatment response might be performed in regular clinical practice, those data will also be collected as well. |
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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 | Acquired Hemophilia A | ||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Bortezomib +Rituximab
Bortezomib +Rituximab
Interventions:
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Publications * |
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* 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 | Unknown status | ||||
Estimated Enrollment ICMJE |
22 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | April 15, 2020 | ||||
Estimated Primary Completion Date | October 15, 2019 (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 | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03700229 | ||||
Other Study ID Numbers ICMJE | PUMCH-AHA-001 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Tienan Zhu, Peking Union Medical College Hospital | ||||
Study Sponsor ICMJE | Peking Union Medical College Hospital | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Peking Union Medical College Hospital | ||||
Verification Date | November 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |