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Study to Evaluate Rituximab and Bortezomib in Patients With Newly Diagnosed Acquired Hemophilia A

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03700229
Recruitment Status : Unknown
Verified November 2018 by Tienan Zhu, Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : October 9, 2018
Last Update Posted : November 23, 2018
Sponsor:
Information provided by (Responsible Party):
Tienan Zhu, Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
Acquired Hemophilia A Drug: Bortezomib Drug: Rituximab Phase 2

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 : 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
Experimental: Bortezomib +Rituximab
Bortezomib +Rituximab
Drug: Bortezomib
Bortezomib intravenously 1.3mg/m2 d1,4,8,11 for 4 doses

Drug: Rituximab
rituximab intravenously 500 mg for one dose




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. The time to durable treatment response [ Time Frame: During 24 month ]
    The time to durable treatment response was defined as the time from date of achieving CR until the date of relapse or date of death from any cause(whichever came first)

  2. Adverse events [ Time Frame: During 24 month ]
    Include major bleeding, infection, nerve toxicity, and so on.

  3. Overall survival [ Time Frame: During 24 month ]
    Overall survival was defined as the time from date of first diagnosis until the date of death from any cause,and death from any cause will be recorded.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must be ≥ 18 years;
  2. Understand and voluntarily sign an ICD prior to any study related assessments/procedures are conducted;
  3. Diagnosis of acquired hemophilia A;
  4. acute bleeding episodes(≥once).

Exclusion Criteria:

  1. Uncontrolled systemic infection;
  2. Allergy to rituximab;
  3. Positive for Lupus anticoagulant;
  4. Life expectancy < 3 months;
  5. Pregnant and breastfeeding women;
  6. Neuropathy>Grade 1;
  7. Positive for Hepatitis B surface antigen or hepatitis C antibody or human immunodeficiency virus(HIV)antibody;
  8. Patients with poor compliance;
  9. Patient who is considered by the investigator not suitable for clinical study.

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): NCT03700229


Contacts
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Contact: Huacong Cai 01069158271 caihc@pumch.cn
Contact: Tienan Zhu 01069158271 zhutn@pumch.cn

Locations
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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         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Tienan Zhu Peking Union Medical College Hospital
Publications of Results:
Other Publications:
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Responsible Party: Tienan Zhu, Associate chief physician, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03700229    
Other Study ID Numbers: PUMCH-AHA-001
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: November 23, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Rituximab
Bortezomib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents