NCT03700229

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

October 10, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2020

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

1 year

First QC Date

October 4, 2018

Last Update Submit

November 20, 2018

Conditions

Acquired Hemophilia A

Outcome Measures

Primary Outcomes (1)

  • The time to attain first complete remission (CR)

    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

    Last day of the treatment regimen (up to 3 months)

Secondary Outcomes (3)

  • The time to durable treatment response

    During 24 month

  • Adverse events

    During 24 month

  • Overall survival

    During 24 month

Study Arms (1)

Bortezomib +Rituximab

EXPERIMENTAL

Bortezomib +Rituximab

Drug: BortezomibDrug: Rituximab

Interventions

BortezomibDRUG

Bortezomib intravenously 1.3mg/m2 d1,4,8,11 for 4 doses

Bortezomib +Rituximab
RituximabDRUG

rituximab intravenously 500 mg for one dose

Bortezomib +Rituximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (4)

  • Collins P, Baudo F, Knoebl P, Levesque H, Nemes L, Pellegrini F, Marco P, Tengborn L, Huth-Kuhne A; EACH2 registry collaborators. Immunosuppression for acquired hemophilia A: results from the European Acquired Haemophilia Registry (EACH2). Blood. 2012 Jul 5;120(1):47-55. doi: 10.1182/blood-2012-02-409185. Epub 2012 Apr 18.

    PMID: 22517903BACKGROUND

  • Bras GP, Pinto RJ, Carvalho MM, Fernandes SP, Andrade JJ, Guimaraes JE. Bortezomib: Potential Key Role in the Treatment of Multiple Myeloma-Related Acquired Hemophilia A. Semin Thromb Hemost. 2017 Feb;43(1):109-112. doi: 10.1055/s-0036-1597648. Epub 2016 Dec 19. No abstract available.

    PMID: 27992938BACKGROUND

  • Bonfanti C, Crestani S, Frattini F, Sissa C, Franchini M. Role of rituximab in the treatment of postpartum acquired haemophilia A: a systematic review of the literature. Blood Transfus. 2015 Jul;13(3):396-400. doi: 10.2450/2014.0242-14. Epub 2014 Dec 17. No abstract available.

    PMID: 25545867BACKGROUND

  • Ratnasingam S, Walker PA, Tran H, Kaplan ZS, McFadyen JD, Tran H, Teh TC, Fleming S, Catalano JV, Chunilal SD, Johnston A, Opat SS, Shortt J. Bortezomib-based antibody depletion for refractory autoimmune hematological diseases. Blood Adv. 2016 Nov 22;1(1):31-35. doi: 10.1182/bloodadvances.2016001412. eCollection 2016 Nov 29.

    PMID: 29296693RESULT

MeSH Terms

Conditions

Factor 8 deficiency, acquired

Interventions

BortezomibRituximab

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Tienan Zhu

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Huacong Cai

CONTACT

01069158271caihc@pumch.cn

Tienan Zhu

CONTACT

01069158271zhutn@pumch.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate chief physician

Study Record Dates

First Submitted

October 4, 2018

First Posted

October 9, 2018

Study Start

October 10, 2018

Primary Completion

October 15, 2019

Study Completion

April 15, 2020

Last Updated

November 23, 2018

Record last verified: 2018-11

Locations

CN(1)